BIOPESTICIDES REGISTRATION ACTION DOCUMENT



# 3

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- one PC Code : 068403

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

January 1 6 , 201 33 - decen - 2 - one Page 2 of 30 Biopesticides Registration Action Document TABLE OF CONTENTS I. EXECUTIVE SUMMARY: ................................ ................................ ................................ 5 II. ACTIVE INGREDIENT OV ERVIEW ................................ ................................ .............. 7 II I. REGULATORY BACKGROUN D ................................ ................................ ...................... 7 A. Classification ................................ ................................ ................................ ........................ 7 B. Food Clearances/Tolerances ................................ ................................ ............................... 8 IV. RISK ASSESSMENT ................................ ................................ ................................ ......... 9 A. Active Ingredient Characterization ................................ ................................ .................... 9 B. Human Health Assessment ................................ ................................ ................................ 10 1. Toxicology ................................ ................................ ................................ ................................ .................... 10 2. Dose Response A ssessment ................................ ................................ ................................ ......................... 13 3. Food Quality Protection Act (FQPA) Considerations ................................ ................................ .............. 13 4. Occupational, Residential, School and Day Care Exposure and Risk Characterization ...................... 17 5. Aggregate Exposure from Multiple Routes Including Dermal, Oral, and Inhalation ........................... 18 6. Cumulative Effects ................................ ................................ ................................ ................................ ...... 18 7. Risk Characterization ................................ ................................ ................................ ................................ . 19 C. Environmental Assessment ................................ ................................ ............................... 19 1. Ecological Hazards ................................ ................................ ................................ ................................ ...... 19 2. Environmental Fate and Ground Water Data ................................ ................................ .......................... 19 3. Ecological Exposure and Risk Characterization ................................ ................................ ...................... 20 4. Endangered S pecies Assessment ................................ ................................ ................................ ................ 20 D. Efficacy Data ................................ ................................ ................................ ..................... 20 V. RISK MANAGEMENT DECI SION ................................ ................................ ................ 21 A. D etermination of Eligibility for Registration ................................ ................................ .. 21 B. Regulatory Decision ................................ ................................ ................................ ........... 21 C. Environmental Justice ................................ ................................ ................................ ....... 21 VI. A CTIONS REQUIRED BY R EGISTRANTS ................................ ................................ . 22 A. R eporting of Adverse Effects ................................ ................................ ............................ 22 B. Reporting of Hypersensitivity Incidents ................................ ................................ .......... 223 - decen - 2 - one Page 3 of 30 Biopesticides Registration Action Document VII. APPENDIX A. DATA REQ UIREMENTS (40 CFR PA RT 158 - SUBPART U) .......... 22 VIII. APPENDIX B. ................................ ................................ ................................ .................... 27 IX. APPENDIX C. ................................ ................................ ................................ ................... 27 X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS ................................ ............. 283 - decen - 2 - one Page 4 of 30 Biopesticides Registration Action Document 

### BIOPESTICIDES REGISTRATION ACTION DOCUMENT (BRAD) TEAM



## Branch Chief Linda A. Hollis, M.S. Product Chemistry/ Human Health Effects/Nontarget Organisms Angela L. Gonzales, Biologist Regulatory Action Leader Colin G. Walsh, M.S., Biologist3 - decen - 2 - one Page 5 of 30 Biopesticides Registration Action Document I. EXECUTIVE SUMMARY: 3

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- one is a new biochemical pesticide active ingredient intended for postharvest use on stored potatoes as a sprout inhibitor
. 3

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- one is a naturally occurring biochemical substance, with a history of unremarkable human exposure. 3

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- one functions as a plant growth regulator, a ffecting plant growth by increasing tuber respiration. D ata on file indicate that 3

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- one interferes with membrane integrity, which results in increased oxidative stress, desiccation, and rapid necrosis of the meristems and surrounding sprout tissues. Thus, 3

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- one inhibits spro uting, with no observed affects on the potato, potato sweetening, or processing quality. Based on this information, the Agency considers the mode of action to be non

- toxic ( EPA, 2011 ). The Biopesticides and Pollution Prevention Division (BPPD) determined that the data and information submitted for p roduct c hemistry and Tier I a cute t oxicity for 3

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- one satisf y the current guideline requirements. Based on the primary eye and dermal irritation acute toxicity data for 3

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- one, the active ingredien t is toxicity category II. A subchronic 90

- day oral toxicity study (OCSPP 870.3100) on the active ingredient (a.i.) was not conducted. In lieu of the study, EPA used a weight

- of

- the

- evidence (WOE) approach to estimate the likelihood of potential of toxicity from repeat oral exposure to this substance (EPA, 2013)
. First, using an expert system computer program (DEREK Nexus), EPA identified two potential toxicological endpoints for 3

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- one (potential derma l sensitization and in vitro chromosome damage); however, follow

- up studies did not support these as toxicological endpoints. Second, the metabolic pathways of 3

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- one have been characterized and demonstrate that the biochemical is metabolized into innocuous compounds that are either excreted or further metabolized in the fatty acid pathway or citric acid cycle. Third, 3

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- one occurs naturally in some foods and has been used as a food additive without specific repor ts of adverse effects. Fina lly , U.S. Food and Drug Administration ( FDA ) has approved the use of 3

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- one as a synthetic flavoring agent and adjuvant that may be directly added to food under 21 CFR § 172.515 . Based on this evidence, EPA conclude d that 3

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- one has relative ly low toxicity via the repeated oral exposure route
. BPPD granted waiver s from conducting subchronic 90

- day dermal (OCSPP 870.3250) and 90

- day inhalation (OCSPP 870.3465) studies based on the fact that p rolonged dermal exposure is not expected because 3

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- one is not purposely applied to the skin and r epeated inhalation exposure is unlikely due to 3

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- one being applied by a thermal fog generator in a closed system. In addition, significant exposure to humans is not anticipated for 3

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- one based on its indoor use pattern in a closed system and appropriate Personal Protective Equipment (PPE) requirements on the product label. BPPD received data for the prenatal developmental data requirement ( OCSPP 870.3700 ) , T ier I mutagenicity studies [bacterial reverse mutation test (OCSPP 870.5100) and in vitro mammalian cell assay (OCSPP 870.5300 ) ], and a T ier II mutagenicity study [in vivo mammalian erythrocyte micronucleus test assay (OCSPP 870.5395)]. The prenatal develo pmental toxicity study showed a no

- observed

adverse

- effects

- level (NOAEL) of 1,000 mg/kg/day (highest dose tested) for maternal and fetal toxici ty. EPA’s WOE approach showed that 3

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- one was not a mutagen based on the results of the T ier I and T ier I I mutagenicity data. Although the data requirements were satisfied for the new active ingredient, 3

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- one , BPPD notes that s hould future intended end

- use product ( EP ) applications result in different anticipated exposures to humans, the se data requir ements may need to be re addressed.3 - decen - 2 - one Page 6 of 30 Biopesticides Registration Action Document For nontarget organisms and environmental fate data requirements (OCSPP 850.1010 to 850.4450), the nontarget organism data requirements for 3

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- one were waived based on the proposed indoor use pattern. 3

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- on e is proposed for use in end

- use formulations that are applied indoors only as sprout inhibitors on potatoes. The end

- use formulations will be introduced and dispersed as a vapor through air circulation systems in potato storage warehouse facilities and is not expected to be available to nontarget organisms. Based on the indoor use pattern, exposure of 3

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- one to nontarget organisms is expected to be minimal. EPA has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, or soil organisms. Based on the information provided, EPA has no concerns , at this time, for any nontarget organisms exposed to 3

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- one when used in accordance with approved label directions. Given that 3

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- one is applied indoors in a closed system, has low toxicity and presents little, if any , risk to nontarget organisms, EPA has concluded that it is in the best interests of the public to issue the registration for the manufacturing

- use product ( M P ) , AMV

1018 Te chnical (EPA File Symbol No. 5481

- LAI) and the EP , AMV

- 1018 EP (EPA File Symbol No. 5481

- LTR ) , which contain this new active ingredient, 3

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- one . BPPD has reviewed the data and information in support of the requirements for granting registration und er Section 3(c)(5) of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). BPPD has determined that the data and information submitted adequately satisfy current data 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 before they occur. According to this policy, EPA provide s a public comment period prior to making a registration decisio n 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 polic y of making registration actions more transparent, 3

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- one is subject to a 15

- day comment period as a “new active ingredient
. ” EPA has established a comment period of 15 days on the basis of 3

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- one’s minimal toxicity, the determination that 3

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- one presents low risk of any adverse effects to human health and the environment, and critical need for this active ingredient. The notice for this comment period include s the draft Biopesticides Registration Action Document ( BRAD) and draft produc t label s for the M P, AMV

- 1018 Technical, and EP, AMV

- 1018 EP , which contain this new active ingredient, 3

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- one . The docket identification ( ID ) number is EPA

- HQ

- OPP

- 20 10

- 0 064 . The Agency believes that based on the risk assessment and information subm itted in support of the registration of the MP and EP containing 3

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- one , it is in the best interests of the public to issue the registration for AMV

- 1018 Technical and AMV

- 1018 EP
. The basis for this decision can be found in the risk assessment for 3

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- one , which is characterized in this BRAD.3 - decen - 2 - one Page 7 of 30 Biopesticides Registration Action Document II. ACTIVE INGREDIENT OVERVIEW Common Name: 3

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- one Chemical Names: 3

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- one; Heptylidene acetone ; Oenanthylidene acetone Trade & Other Names: AMV

- 1018 Technical CAS Registry Number: 10519

- 33

- 2 OPP Chemical Code: 068403 Type of Pesticide: Plant Growth Regulator (Sprout Inhibitor)
III. REGULATORY BACKGROUND On December 8 , 20 09 , EPA received an application filed by Technology Sciences Group, Inc. (TSG) Exponent, 1150 18 th Street, NW, Suite 1000, Washington, DC 20036 , on behalf of Amvac Chemical Corporation (AMVAC), 4695 MacArthur Court, Ste. 1250, Newport Beach, CA 90660 , to register the product s, AMV

- 1018 Technical (EPA File Symbol No. 5481

- LAI ) , AMV

1018 EP ( EPA File Symbol No. 5481

- LTR ) , AMV

- 1018 90EC (EPA File Symbol N o. 5481

- LTN), and AMV

- 1018 67.5 EC (EPA File Symbol No. 5481

- LAO) co ntaining the new biochemical active ingredient, 3

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- one . The applicant with drew AMV

- 1018 90EC (EPA File Symbol No. 5481

- LTN) and AMV

- 1018 67.5EC (EPA File Symbol No. 5481

- LAO) from consideration by EPA with the letter dated March 2, 2011. A notice of receipt (NOR) of this application, allowing for a 30

- day comment period, was pub lished in the Federal Register o n March 10 , 20 10 (7 5 FR 11175 )
. No comments were received following this publication
. A. Classification On September 22, 2008 , EPA’s B iochemical C lassification C ommittee determined that 3

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- one is a biochemical pesticide. The biochemical classification committee indicated that 3

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- one is a plant growth regulator and the mode of action is to induce a transient increase in tuber respiration rate and seemed to interfere with membrane integrity, r esulting in increased oxidative stress, dessication , and rapid necrosis of meristem and surrounding sprout tissues. The observed effect is primarily mechanical damage to sprout cell membranes. Sweetening and processing quality of potatoes and the mature tu ber were unaffected. 3

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- one is related to class of secondary alcohols, ketones, and related esters naturally occurring in foods, flavor additives, and fragrances. No safety concerns were identified and the substance is rapidly metabolized and excreted from mammals. 3

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- one is approved for use as a synthetic flavor under 21 CFR § 172.515.3 - decen - 2 - one Page 8 of 30 Biopesticides Registration Action Document B. F ood Clearances/Tolerances The applicant filed a petition (PP 9F7670 ) proposing to establish an exemption from the requirement of a tolerance for residues of 3

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- one 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 March 10, 2010 ( 7 5 FR 11171 )
. One comment w as received following this publication and is described below
. A comment was posted to the NOF docket ID number EPA

- HQ

- OPP

- 2010

- 0065 from Mich a el J. Keim, Keim Aerosol Technologies, on April 21, 2010. Mr. Keim believes that EPA has not been adequately informed by the registrants with respect to the use of chemicals for the postharvest treatment of stored potatoes and that 3

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- one does pose a risk to humans and the environment. Mr. Keim’s states that the p rimary reason for his claim stems from the registrant’s use of the same equipment to apply the proposed product, AMV

- 1018 EP, as conventional products containing Chlorpropham (CIPC). Mr. Keim has concerns with EPA’s evaluation of the proposed 3

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- one products and the following year’s (2011) registration review of CIPC applications because there is no mention of the significant displacement and degradation of the chemicals to the outside atmosphere during the application process. Mr. Keim indicates tha t he believes that half of the applied CIPC to stored potatoes does not deposit on the potatoes and, therefore, is expelled to the outside environment. Mr. Keim estimates that approximately 227,500 pounds of CIPC and over 900,000 pounds of 3

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- one ar e lost to the outside environment in the U.S. each year and believes that this displacement must be evaluated in order to determine what testing must be performed to insure no harm comes to humans and the environment. Mr. Keim also provided copies of his c ommunications to Canada’s Pesticide Management Regulatory Authority (PMRA) during its re

- evaluation decision for CIPC in 2007

- 2009, where he did not agree with PMRA’s approval of CIPC. In summary, Mr. Keim indicated that the following data must be submitte d due to the gross displacement and degradation of the proposed product, AMV

1018 EP: 1) product performance data, 2) mammalian toxicity data, 3) nontarget organism data, 4) post

- application exposure data, 5) applicator/user exposure data, 6) spray drift e valuation, 7) environmental fate data, and 8) residue chemistry data. EPA thanks Keim Aerosol Technologies for its comment regarding the NOF for 3

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- one. D ocuments in the docket for the Registration Review of CIPC (docket ID number EPA

- HQ

OPP

- 2010

- 0923 ) prepared by the Agency’s Health Effects Division (HED) and Environmental Fate and Effects Division (EFED) have already responded to Mr. Keim’s comments about the application equipment used for CIPC products and the potential for expos ure based on the displacement and degradation of CIPC. Moreover, with respect to 3

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- one, the Agency has received and reviewed product chemistry, mammalian toxicity, and nontarget organism data and/or information for this new a.i., 3

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- one , as outlined in 40 CFR §§ 158.2030, 158.2050, and 158.2060 (see infra, Section IV) . Based on the risk assessment discussed in the subsequent sections , the Agency has concluded that no unreasonable adverse effects to the U.S. population in general, and to infan ts and children in particular, will result from the use of 3

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- one as a pesticide when label instructions are followed. The data and information submitted to the Agency indicate that 3

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- one is of low acute and subchronic toxicity , with the exc eption that it is a primary eye and dermal irritant , is not a developmental toxicant, and is not mutagenic. With regard to worker exposure, the thermal fogging application method on the3 - decen - 2 - one Page 9 of 30 Biopesticides Registration Action Document proposed product label used for stored potatoes is an automated system and as such, the Agency considers this method a closed

- delivery system and does not expect occupational handler exposure . The only occupational exposure expected is the handling of the product prior to application, which is mitigated by appropriate precau tionary statements and PPE requirements listed on the label. T he Agency has not identified any toxic endpoints for nontarget mammals, birds, plants, aquatic, or soil organisms; therefore, EPA has no concerns for any nontarget organisms exposed to 3

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- one when used in accordance with approved label directions. The applicant did submit information that estimated the physical and chemical properties for 3

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- one by using QSAR modeling based on the Estimation Programs Interface Model (EPI SuiteTM 4.0)
. Using Henry’s Law, which states that the solubility of a gas in a liquid is directly proportional to the partial pressure of the gas above the liquid, 3

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- one is e stimated to be 5.4 x 10 - 4 atm· m 3 /mol and indicates that the a.i. has a potential for volatility from water or moist soil. In soil, the estimated K oc of 165.2

– 860.9 L/kg indicates that the active would have medium to low mobility in soil. In water, an estimated log K ow of 3.28 and an estimated bioconcentration factor ( BCF ) of 67.41 L/kg wet

- wt indicate that bioaccumulation in aquatic organisms is unlikely. In the air, atmospheric oxidation by reaction of hydroxyl radicals is expected to occur with estimated half

- lives of 1.9

– 2.2 hours. The probability of biodegradation o f 3

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- one was evaluated using EPI SuiteTM 4.0 in the BIOWIN module. Various models in the BIOWIN module predicted rapid biodegradation of 3

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- one . Based on a total air volume in potato warehouse of 1910 m 3 and total applied 3

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- one of 122, 475 g calculated by the applicant, the maximum air concentration of 3

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- one in warehouse was estimated to be 64.14 mg/L of air. With an estimated ventilation rate of 825 m 3 of air/min, the air volume in a warehouse will be exchanged within 2.5 minute s when the vents to the outdoors are opened. Thus, the concentration emitted will be rapidly diluted in the outside air , which further demonstrates insignificant exposure to nontarget organisms
. In summary, g iven that 3

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- one is applied indoors in a closed system, has low toxicity , and presents little, if any , risk to nontarget organisms, the Agency has concluded that products containing this new a.i., 3

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- one, are not expected to cau se unreasonable adverse effects to humans, including infants and children, and nontarget organisms. EPA determined during the initial review of the petition that the data and/or information submitted was insufficient to support the use of the active ingredient, 3

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- one , in or on all food commodities . T he applicant filed a revised petition (PP 9F7670) proposing to establish an exemption from the requirement of a tolerance for residues of 3

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- one in or on stored potatoes only. A NOF, allowing for a 30

- day comment period, was published in the Federal Re gister on March 14, 2012 (77 FR 15012). No comments were received following this publication. IV. RISK ASSESSMENT A. Active Ingredient Characterization 3

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- one is a new biochemical pesticide active ingredient intended for postharvest use on stored potatoes as a sprout inhibitor
. 3

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- one is a naturally occurring biochemical substance, with a history of unremarkable human exposure. 3

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- one functions as a plant3 - decen - 2 - one Page 10 of 30 Biopesticides Registration Action Document growth regulator, effecting plant growth by increasing tuber respiration. D ata on file indicate that 3

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- one interferes with membrane integrity, which results in increased oxidative stress, desiccation, and rapid necrosis of the meristems and surroun ding sprout tissues. Thus, 3

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- one inhibits sprouting, with no observed affects on the potato, potato sweetening, or processing quality. Based on this information, the Agency considers the mode of action to be nontoxic ( EPA, 201 1 ). 3

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- one has been found to naturally occur in yogurt, skipjack tuna, edible porcini mushrooms , and Iberian ham (EPA, 2013 ). Additionally, in a 2003 report, the Joint FAO/WHO Expert Committee on Food Additives (JECFA) indicated that 3

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- one is one in a group of c ompounds that have been identified in fruits, vegetables, spices, cocoa, coffee , and tea ( JECFA , 20 03 ). JECFA also concluded in their report that there is no safety concern at current intake levels when the chemical is used as a flavoring agent. The chemic al has been approved by FDA as a food additive without limitation under 21 CFR § 172.515. According to a report by an independent panel of experts retained by the Flavor and Extract Manufacturer’s Association (FEMA), 3

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- one is considered safe for it s intended use when added at an average maximum level of 19 ppm in baked goods, 7.8 ppm in soft candy, 5.8 ppm in frozen dairy products, 4.8 ppm in gelatins and puddings, 4.3 ppm in non

- alcoholic beverages , and 4.0 ppm in alcoholic beverages (EPA, 2013 ). D escriptions of the product formulation and production process, formation of impurities, and physical and chemical characteristics were examined by BPPD and found to be acceptable in meeting current guideline standards
. All product chemistry data requireme nts for registration of 3

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- one have been satisfied. For more information regarding product chemistry data requirements, refer to Tables 3 and 4 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
. Adequate mammalian toxicology data /information is available to support registration of 3

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- one . All toxicology data requirements for 3

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- one 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).3 - decen - 2 - one Page 11 of 30 Biopesticides Registration Action Document Tier I acute toxicity studies submitted and reviewed showed that 3

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- one is moderately irritating to the eye and severely irritating to the skin based on the res ults of primary eye irritation and primary dermal irritation studies in rabbits, respectively ( t oxicity c ategory II). 3

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- one is a toxicity category II I (slightly toxic) compound via the inhalation route of exposure, based on LC 50 0.52

- 2.04 mg/L in m ale rats and > 2.04 mg/L in female rats
. 3

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- one falls in t oxicity c ategory IV (not toxic) for acute oral toxicity and acute dermal toxicity
. 3

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- one is not a dermal sensitizer. For more information regarding acute toxicity data requirements, refer to Table 5 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 cont inuous exposure to a te st substance for a period of 90 days
. A subchronic 90

- day oral toxicity study (OCSPP 870.3100) on the a.i. was not conducted. In lieu of the study, EPA used a WOE approach to estimate the likelihood of potential of toxicity from r epeat oral exposure to this substance. EPA considered the following evidence: (1) lack of toxicological endpoints; (2) metabolic pathways, (3) lack of incidents associated with naturally occurring levels of 3

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- one in foods, and (4) FDA’s approval o f this biochemical as a direct food additive. This evidence is further expanded on below. i. U sing an expert system computer program (DEREK Nexus), EPA identified two potential toxicological endpoints for 3

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- one (potential dermal sensitization a nd in vitro chromosome damage); however, follow

- up studies did not support these as toxicological endpoints. ii. T he metabolic pathways of 3

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- one have been characterized and demonstrate that the biochemical is metabolized into innocuous compounds th at are either excreted or further metabolized in the fatty acid pathway or citric acid cycle
. ii i
. 3

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- one occurs naturally in some foods and has been used as a food additive without specific reports of adverse effects
. iv
. FDA has approved the use of 3

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- one as a synthetic flavoring agent and adjuvant that may be directly added to food under 21 CFR § 172.515
. Based on th e above evidence, EPA concluded that 3

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- one has relatively low toxicity via the repeated oral exposure route and 90 d ay oral toxicity data requirement for this a.i. has been satisfied
. W aiver request s for the subchronic 90

- day dermal toxicity (O CS PP 870.325 0) and 90

- day inhalation toxicity (OCSPP 870.3465) data requirements w ere granted by BPPD, based on the 3

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- o ne’s toxicological and exposure profile , summarized below. i. Prolonged dermal exposure is not expected because 3

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- one is not purposely applied to the skin and do not result in comparable human exposure to the3 - decen - 2 - one Page 12 of 30 Biopesticides Registration Action Document product
. ii. Repeated inhalation exp osure is unlikely because 3

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- one is applied by a thermal fog generator in a closed system. Personnel are not allowed in the potato storage facilities during application and evacuation of the product. In addition, any unlikely inhalation exposure wil l be mitigated on the label by precautionary statements and PPE requirements. For more information regarding the subchronic toxicity data requirements, refer to Table 5 in Appendix A.
c. Developmental Toxicity and Mutagenicity The T ier I prenatal d evelopmental toxicity study ( OCSPP 870.3700 ) submitted and reviewed showed that the maternal and fetal (developmental) toxicity NOAEL was 1,000 mg/kg/day (the highest dose tested). A lower bodyweight gain effect was seen in the highest

- dose group (1,000 mg/kg/day) for maternal rats; however, the bodyweight gain effect is considered to be attributable to the palatability of the test substance and not toxicologically significant. T he T ier I mutagenicity stud ies [ bacterial reverse mutation test (OCSPP 870.5100) and in vitro mammalian cell assay (OCSPP 870.5300 ) ] and T ier II mutagenicity study [in vivo mammalian er y th r ocyte micronucleus test assay (OCSPP 870.5395)] submi tted and reviewed showed that 3

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- one is not mutagenic. Results were ne gative in the bacterial reverse mutation test. In an in vitro mammalian gene mutation assay (mouse lymphoma cell) , results were positive without metabolic activation and results were equivocal with metabolic activation
. These results are considered equivoc al because it was not clear whether the positive results would translate into an in vivo system based on the increased osmotic pressure and marked cytotoxicity noted during the experiment. Results of an in vivo mammalian erythrocyte micronucleus test assay were negative for the a.i. ; therefore, the WOE approach indicates that 3

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- one is not likely to be mutagenic. For more information regarding developmental and mutagenicity data requirements, refer to Table 5 in Appendix A
. d. Tier II/Tier III No data were required , except to confirm that 3

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- one is not a mutagen (see section B.1.c above) due to the nature of the active ingredient and its intended indoor uses in potential new EP products ( potato sprout inhibitor ).
e. E ffects on the Endocrine System As required under F ederal Food, Drug, and Cosmetic Act (F FDCA ) section 408(p), EPA has developed the Endocrine Disruptor Screening Program (EDSP) to determine whether certain subst ances (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 to3 - decen - 2 - one Page 13 of 30 Biopesticides Registration Action Document 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. Chem icals 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 availa ble 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/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, res idential activity, and certain post

- application agricultural scenarios. This list should not be construed as a list of known or likely endocrine disruptors. 3

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- one 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/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 n o toxicolog ical endpoints were identified for this active ingredient , a dose

- respon se assessment was not required. 3. Food Quality Protection Act (FQPA) Considerations
a. Dietary Exposure and Risk Characterization Human exposure to 3

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- one may occur via dietary exposure to treated p otatoes. A qualitative risk assessment was conducted for the chemical to assess potential risks (if any) from dietary exposure. Although dietary exposure to humans may occur, the Agency has determined that there is reasonable certainty of no harm to humans when exposed to residues of the active ingredient from pesticidal use when label instructions are followed. This conclusion is based on the following: 1) available toxicology data and information indicate that the active ingredient is of low acute toxicit y (with the exception that it is an eye and skin irritant) and not likely to be a developmental toxicant, a mutagen or toxic via repeat oral exposure, 2) humans are already exposed to 3

- decen

- 2

- one in the diet from foods that naturally contain the chemical and from foods to which the chemical has been added as a food additive, 3) metabolism data and information on the chemical indicate that it is metabolized into innocuous substances in humans, and 4) simplistic exposure analyses suggest that dietary exposu re to the chemical as a pesticide is likely to be less than dietary exposure to the chemical as a food additive and as a natural3 - decen - 2 - one Page 14 of 30 Biopesticides Registration Action Document constituent in foods and pesticidal use of 3

- decen

- 2

- one is not likely to result in a significant increase in overall dietary e xposure (EPA, 2013 )
. A detailed discussion of how the Agency arrived at its conclusion is provided in the subsequent paragraphs. Residues Previous residue data submitted by the applicant indicate that residues of 3

- decen

- 2

- one persist in treated potatoes for up to 61 days post

- treatment (after one application) , although there is a substantial reduction over time (EPA, 2011)
. In support of th e revised petition, a new residue study was conducted on stored Ranger Russet potatoes treated with one application of AMV

1018 (the end

- use product containing 98% 3

- decen

- 2

- one; EPA File Symbol No. 5481

- LTR) at twice the maximum application label rate. Po tatoes were analyzed for residues when raw, steamed and baked at 1, 3, 5, 7 and 14 days after treatment. The study was terminated after day 14. Prior to cooking and/or analysis, potatoes were “gently” washed with a vegetable brush. Tubers were prepared by quartering each potato, chopping one of the quarters into cubes, mixing the cubes for random distribution and then storing at

- 80oC. The residue data are summarized in Table 1 below. Table 1: 3 - Decen - 2 - one Residues in Raw, Steamed , and Baked Potatoes Trea ted with 230 mg/kg AMV - 1018 (98% 3 - decen - 2 - one) Days After Treatment Raw (ppm) Steamed (ppm) Baked (ppm) 1 2.224 0.256 0.550 3 1.262 0.255 0.548 7 0.747 0.193 0.347 14 0.459 0.112 0.274 The residue study demonstrated that 3

- decen

- 2

- one residues are reduced when potatoes are cooked. Residues remained on all forms of potatoes through 14 days, when the study was terminated. Based on the results of the pre viously submitted residue study, residues of 3

- decen

2

- one are likely to persist longer than 14 days , although they decrease over time. It is noted that since potatoes were “gently” washed with a vegetable brush prior to residue analysis, some residues of the active ingredient were likely washed off. Per the applicant, potatoes were washed to simulate no rmal behavior of consumers who generally wash potatoes prior to cooking and eating. Comparison of Dietary Exposure from Different Sources of 3

- Decen

- 2

- One A simplistic quantitative evaluation of potential dietary exposure to children from consumption of pesticide

- treated potatoes was conducted and compared to estimated dietary exposure to 3

- decen

- 2

- one as a natural constituent of food and as a food additive. Children (1 to 2 years old) were chosen as a representative group to assess exposure due to likely consumption of potatoes and potato

- products and because children are considered a sensitive subgroup of the population. The assessment indicates that overall dietary exposure to the chemical as a naturally

- occurring component in foods and as a food additi ve is not likely to substantially increase from exposure via consumption by children of potatoes treated with the active ingredient as a pesticide when label instructions are followed (EPA, 2013 )
.3 - decen - 2 - one Page 15 of 30 Biopesticides Registration Action Document Dietary exposure to 3

- decen

- 2

- one as a natural constituent in foods was evaluated by using a quantitative estimation of the amount of the chemical likely found in fermented milk (yogurt) and calculating the potential exposure to children, aged 1

- 2 years. The applicant identified two scientific articles where info rmation to calculate the naturally occurring amount of 3

- decen

- 2

- one was taken. The active ingredient has been identified by gas chromatography (GC) as a volatile constituent in four types of yogurt (Patrignani et al., 2009); however, the amount was not q uantified. In another study where some volatile constituents of yogurt were analyzed (Ott et al., 2000), the amount of acetaldehyde present in five different types of yogurt was quantified and found to be at an average concentration of 10.82 ppm. Acetaldeh yde was also identified in the Patrignani study, but not quantified. Because acetaldehyde was the only volatile constituent found in both studies, it was used as a surrogate to estimate the amount of 3

- decen

- 2

- one found in the Patrignani study. The average amount of acetaldehyde in the Ott study was assumed to be the same in the Patrignani study. The relationship between the peak areas of 3

- decen

- 2

- one and acetaldehyde measured using GC was considered to be equivalent to the relationship between the average concentration of 3

- decen

- 2

- one and acetaldehyde. The amount of the active ingredient was then estimated by dividing the 3

- decen

- 2

- one peak area by the acetaldehyde peak area for each of the four yogurt types in the Patrignani study. For the purposes of th is assessment, the Agency considers this a reasonable approach for estimation of 3

- decen

- 2

- one concentration in yogurt. Since the yogurts were analyzed after one day and then after 14 days of storage, instead of four concentration estimates, eight estimate s of 3

- decen

- 2

- one concentrations were calculated. These concentrations ranged from 2.15

- 11.15 ppm with the average of 7.64 ppm. To estimate the average amount of yogurt consumed by children per day, EPA’s Exposure Factors Handbook (U
. S
. EPA, 2011) was con sulted which indicated that the mean per capita yogurt intake by children aged 1

- 2 years is 12 g/day; the consumer

- only intake was not available. The Exposure Factors Handbook (EFH) indicates that approximately 8.4% of the age group consumes yogurt. It is anticipated that the consumer

- only intake is considerably higher (for perspective, a 3.5 oz container of yogurt weighs approximately 100 g). With regard to this assessment, the per capita intake is the average yogurt consumed per person in a population of both individuals who ate yogurt during a specified time and those who did not and the consumer

- only intake is the average yogurt consumed per person in a population composed only of people who ate yogurt during a specified period. Using the average estimat ed concentration of 3

- decen

- 2

- one in yogurt and the average amount of yogurt consumed by children per day, an estimate of dietary exposure was calculated. The concentration of the active ingredient (ppm, or μg/g) is multiplied by the grams of yogurt consum ed per day; the resulting number is then adjusted for inclusion of body weight (the average body weight of a child aged 1

- 2 years is 11.4 kg ( U.S. EPA , 2011) ) . Assuming consumption of 12 g yogurt/day, the dietary exposure for children is as follows: 7 .64 μg 3

- decen

- 2

- one/g yogurt × 12 g yogurt consumed/day = 91.68 μg 3

- decen

- 2

- one/day ; 91.68 μg/day ÷ 11.4 kg bodyweight = 8.04 μg 3 - decen - 2 - one/kg body weight/day Thus, the estimated exposure to 3

- decen

- 2

- one of a child consuming 12 g of yogurt per day is 8.04 μg/kg bw/day. To account for the lack of consumer

- only intake data and to use a more conservative approach, an estimate of 50 g yogurt (which is approximately half of a 3.5 oz container of yogurt) consumed per day was employed. Using this consumption amount and the3 - decen - 2 - one Page 16 of 30 Biopesticides Registration Action Document same calculation presented above, the estimated exposure of a child consuming 50 g of yogurt per day is 33.5 μg/kg bw/day . Based on these data, the amount of the chemical consumed by children aged 1

- 2 years is estimated to range from 8.04 - 33.5 μg/kg bw/day Dietary exposure to 3

- decen

- 2

- one as a food additive was also evaluated using the same methodology and calculations presented above and the levels of the chemical added to food as described by Oser and Ford (1978)
. According to this report, the chemical is considered safe for its intended use when added to baked goods at an average maximum of 19 ppm and to nonalcoholic beverages at an average maximum of 4.3 ppm. According to the EFH, the average daily per capita intake of bread (includes breads, rolls, muff ins, bagels, biscuits, cornbread and tortillas) for children aged 1

- 2 years is 2 g/kg bw/day. The average per capita intake of non

- citrus juices and nectars and citrus juices is 132 g/day and 49 g/day, respectively. The juice intake values were chosen as r easonable representations for nonalcoholic beverages that children may ingest. Because the amounts of 3

- decen

- 2

- one added to food are considered maximum amounts, two calculations for each food group were performed to create a range of dietary exposure esti mates. The first estimate is based on exposure to the maximum amount of the chemical added to the specific food group and the second estimate is based on the maximum amount of the chemical divided in half. The division is considered a reasonable estimate f or levels of 3

- decen

2

- one that may be generally added to food and is useful in creating a range of possible dietary exposures. For example, for baked goods, the maximum amount of the chemical added can be 19 ppm; to estimate dietary exposures, concentrati ons of 19 ppm and 9.5 ppm were used in the calculations. Assessments similar to those discussed regarding dietary exposure to 3

- decen

- 2

- one in yogurt suggest a range of dietary exposures of 19 .0

- 38.0 μg/kg bw/day in baked goods and 9.24 - 49.8 μg/kg bw/day ( 24.9

- 49. 8 μg/kg bw/day in non

- citrus juices and nectars and 9.2

- 18.5 μg/kg bw/day in citrus juices) in nonalcoholic beverages. Dietary exposure to 3

- decen

- 2

- one from use as a pesticide was evaluated by using the residue data presented in Table 2 and si milar calculations to those discussed above. Residues in the amount of 0.550 ppm 3

- decen

- 2

- one were identified in potatoes that were baked one day after treatment with double the application rate on the label. The residue value for baked potatoes was selec ted since children are not likely to eat raw potatoes. The label indicates that 4 applications of the pesticide can be made in 7

- day increments. A conservative estimate of potential residues after four pesticide applications was conducted by using the resi due value for baked potatoes at day 1 and multiplying that value by four. The estimate is conservative because it is assumed that four applications of the pesticide will be made all at one time and potatoes will be consumed at day 1 after treatment when in reality, the pesticide will not be applied all in one interval and residue data indicate that levels of 3

- decen

- 2

- one decline in potatoes over time. According to the EFH, the average consumer

- only intake of white potatoes by children aged 1

- 2 years is 1.8 6 g/kg bw/day (uncooked weight). Using the type of calculations discussed above, the estimated dietary exposure to children from exposure to 3

- decen

- 2

- one as a pesticide is 4.1 μg/kg bw/day . The estimated dietary exposures for children aged 1

- 2 years as ca lculated and discussed above are summarized in Table 2 below
.3 - decen - 2 - one Page 17 of 30 Biopesticides Registration Action Document Table 2: Estimated Dietary Exposures to 3 - decen - 2 - one for Children Aged 1 - 2 Years Source of 3 - decen - 2 - one Estimated Dietary Exposure (μg/kg bw/day) Naturally

- occurring constituent of yogurt 8.0

- 33.5 Food additive in baked goods 19.0

– 38.0 Food additive in nonalcoholic beverages: Non

- citrus juices and nectars Citrus juices 24.9

– 49.8 (non

- citrus) 9.24

- 18.5 (citrus) Pesticide residues on baked potatoes 4.1 The information presented above suggests that dietary exposure to residues of 3

- decen

- 2

- one used as a pesticide is likely to be less than dietary exposure to the chemical as a naturally occurring constituent in food and/or as a food additive. Further, when compared to the amount of the chemical that is likely already consumed in the human diet, pesticidal use is not anticipated to significantly increase overall human dietary exposure to 3

- decen

- 2

- one as a food additive and a natural constituent in food (EPA, 2013 )
. b
. Drin king Water Exposure and Risk Characterization Based on the proposed use pattern of the active ingredient as a potato sprout inhibitor used in indoor settings, residues in drinking water are not anticipated if products are used according to label instructi ons. Products containing the active ingredient will be used in indoor commercial settings only; therefore, 3

- decen

- 2

- one residues in drinking water are highly unlikely. 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 3

- decen

- 2

- one.
c . Acute and Chronic Dietary Risks for Sensitive Subpopulations Particularly Infants and Children The Agency has determined that there are no foreseeable dietary risks to sensitive subpopulations, including infants and children, from the use of 3

- decen

- 2

- one as a pesticide on stored potatoes when label instructions are followed. The available data and information indicate that the chemical: 1) is of low toxicity and is not a developmental toxicant; 2) naturally occurs in the human diet; 3) has been approved for use in foods as a food additive by the FDA ; and 4) is metabolized into innocuous substances. Additionally, basic exposure analyses that were specifically conducted for children aged 1

- 2 years suggest that dietary exposure from ingestion of the chemical as a pesticide is likely to be less that dietary exposure from ingestion of the chemical as a fo od additive and/or as a constituent that naturally occurs in foods. When compared to the amount of 3

- decen

- 2

- one that is likely already consumed in the human diet, dietary exposure from pesticidal use is not anticipated to significantly increase overall di etary exposure of infants and children. 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 3

- decen

- 2

- one , a nd is not required.3 - decen - 2 - one Page 18 of 30 Biopesticides Registration Action Document Significant occupational exposure is not expected when 3

- decen

- 2

- one is used according to label instructions. Products containing this active ingredient are intended for indoor use as a sprout inhibitor on stored potatoes. The applicati on method is a thermal fog generator in a closed system. The end

- use product is fogged into the storage area by way of the ventilation ducts and re - circulated through the air by the ventilation system for 24 hours. After the re

- circulation is complete, the ventilation louvers will be opened and the air in the storage area will be evacuated to the outside. The only occupational exposure expected is the handling of the product prior to application, which is mitigated by appropriate precautionary statements an d PPE requirements listed on the label. This will include instructions for applicator PPE, which includes: coveralls worn over long sleeve shirt and long pants, socks, chemical resistant footwear, chemical

- resistant gloves, face shie ld or shielded safety glasses, and appropriate PPE for potential exposure via the inhalation route. 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 3

- decen

- 2

- one will be minimal in residential, school, and day care areas, as the end

use product containing this active ingredient is intend ed for use as a sprout inhibitor on stored potatoes in a closed system. 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 3

- decen

- 2

- one. This includes all exposures for which there is reliable information. Based on the use pattern of the chemical as a sprout inhibitor on s tored potatoes in a closed system and appropriate personal PPE requirements on the label, significant exposure via the dermal and inhalation routes is not anticipated when label instructions are followed. Dietary (oral) exposure has been identified as the only likely route of exposure. Exposure is not anticipated in drinking water based on the use pattern and the pesticide is not to be used in residential settings. The chemical ’s highly specific mode of action as a sprout inhibitor , its l ow toxicity (with t he exception t hat 3

- decen

- 2

- one is an eye and skin irritant) further support the EPA’s conclusion
. In consideration of the above information, the Agency has determined the risk from aggregate exposure (via oral, dermal, and inhalation exposures) is negligi ble. 6 . Cumulative Effects Pursuant to FFDCA section 408(b)(2)(D)(v), EPA has considered available information concerning the cumulative effects of 3

- decen

- 2

- one residues and other substances that have a common mechanism of toxicity. Unlik e other pesticides for which EPA has followed a cumulative risk approach based on a c ommon mechanism of toxicity, the Agency has not made a common mechanism of toxicit y finding for 3

- decen

- 2

- one and any other substances and 3

- decen

2

- one does not appear to produce a toxic metabolite produced by other substances. The active ingredient is a biopesticide that has a nontoxic mode of action. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumul ative effects of such chemicals, see the pol icy statements released by the Agency’s Office3 - decen - 2 - one Page 19 of 30 Biopesticides Registration Action Document of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s webs ite at http://www.epa.gov/pesticides/cumulative/. 7. Risk Characterization EPA has considered human exposure to 3

- decen

- 2

- one in light of the relevant safety factors in FQPA and FIFRA and has determined 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 3

- decen

- 2

- one as a pesticide when label instructions are followed. C. E nvironmental Assessment 1. Ecological Hazards The nontarget organism data requirements for 3

- decen

- 2

- one are waived based on the proposed indoor use pattern. 3

- decen

- 2

- one is proposed for use in end

- use formulations that are applied in indoors only as sprout inhibitors on potatoes. The end

- use formulations will be introduced and dispersed as a vapor through air circulation systems in potato storage warehouse facilities and is not expected to be available to nontarget organisms. Based on the indoor use pattern, exposure of 3

- decen

- 2

- one to nontarget organisms is expected to be minimal. All non target toxicology data requirements for 3

- decen

- 2

- one have been satisfied. For more information regarding nontarget organism toxicity data requirements, refer to Table 6 in Appendix A
. 2. Environmental Fate and Ground Water Data The need for environm ental fate and groundwater data is not required based on the proposed indoor use pattern of 3

- decen

- 2

- one and the information submitted for the nontarget organism toxicology data requirements, which did not trigger additional Tier I studies. The applicant did submit information that estimated the physical and chemical properties for 3

- decen

- 2

- one by using QSAR modeling based on the Estimation Programs Interface Model (EPI SuiteTM 4.0). Using Henry’s Law, which states that the solubility of a gas in a liquid is directly proportional to the partial pressure of the gas above the liquid, 3

- decen

- 2

- one is e stimated to be 5.4 x 10 - 4 atm· m 3 /mol and indicates that the a.i. has a potential for volatility from water or moist soil. In soil, the estimated K oc of 165.2

– 860.9 L/kg indicates that the a.i. would have medium to low mobility in soil. In water, an estimated log K ow of 3.28 and an estimated BCF of 67.41 L/kg wet

wt indicate that bioaccumulation in aquatic organisms is unlikely. In the air, atmospheric oxidation by reaction of hydroxyl radicals is expected to occur with estimated half

- lives of 1.9

– 2.2 hours. The pro bability of biodegradation of 3

- decen

- 2

- one was evaluated using EPI SuiteTM 4.0 in the BIOWIN module. Various models in the BIOWIN module predicted rapid biodegradation of 3

- decen

- 2

- one . Based on a total air volume in potato warehouse of 1 , 910 m 3 and total applied 3

- decen

- 2

- one of 122,475 g calculated by the applicant, the maximum air concentration of 3

- decen

- 2

- one in warehouse was estimated to be 64.14 mg/L of air. With an estimated ventilation rate of 825 m 3 of air/min, the air volume in a warehouse will b e exchanged3 - decen - 2 - one Page 20 of 30 Biopesticides Registration Action Document within 2.5 minutes when the vents to the outdoors are opened. Thus, the concentration emitted will be rapidly diluted in the outside air , which further demonstrates insignificant exposure to nontarget organisms
. 3. Ecological Exposure and Risk Characterization Significant exposure and risk to nontarget organisms is not expected because of the proposed indoor use pattern as a sprout inhibitor on potatoes for 3

- decen

- 2

- one. The end

- use formulations will be introduced and dispersed as a vapor through air circulation systems in potato storage warehouse facilities and are not expected to be available to nontarget organisms. In addition, the estimated ventilation rate of 825 m 3 of air/min in the potato storage warehouse facilities will exchange t he air volume in the warehouse within 2.5 minutes when the vents to the outdoors are opened ; therefore , the concentration emitted will be rapidly diluted in the outside air. 4. Endangered Species Assessment Tier I studies were not submitted for 3

- decen

- 2

- one, but are not required. Based on its use pattern and use instructions as a sprout inhibitor on stored potatoes intended for use in indoor, enclosed potato storage facilities, exposure to nontarget organisms is not expected. Based on its use pattern an d use instructions, EPA has determined 3

- decen

- 2

- one will have “ No Effect ” on any currently listed threatened or endangered species or any designated critical habitat. 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 o f efficacy data for any pesticide product registered or proposed for registration that are intended to be used to control a pest of significance public health importance and a public health pest as defined in FIFRA section 28(d) and section 2(nn). For furt her 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/pesti cides/health/risk

benefit.htm ). The EPs 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.3 - decen - 2 - one Page 21 of 30 Biopesticides Registration Action Document V. R ISK 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 accordan ce 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 assessment s supporting products containing the technical grade active ingredient , 3

- decen

- 2

- one . Such products are not expected to cau se unreasonable adverse effects
. Therefore, 3

- decen

- 2

- one as a technical grade active ingredient is eligible for registration for th e labeled uses. B. Regulatory Decision The data submitted fulfill the registration requirements of 3

- decen

- 2

- one for use as a potato sprout inhibitor
. Refer to Appendix B for product

- specific information. Conditional/Unconditional Registration All data requirements are fulfilled, and EPA determined that an unconditional registration of 3

- decen

- 2

- one is appropriate. Consistent with the policy of making registration actions more transparent, 3

- decen

- 2

- one is subject to a 15

- day comment period as a “new active ingredient.” EPA has established a comment period of 15 days on the basis of 3

- decen

- 2

- one’s minimal toxicity, the determination that 3

- decen

- 2

- one presents low risk of any adverse effects to human health and the environment, and critical nee d for this active ingredient. The notice for this comment period includes the draft Biopesticides Registration Action Document (BRAD) and draft product labels for the MP, AMV

- 1018 Technical, and EP, AMV

- 1018 EP, which contain this new active ingredient, 3

- decen

- 2

- one. The docket identification (ID) number is EPA

- HQ

- OPP

- 2010

- 0064. The Agency believes that based on the risk assessment and information submitted in support of the registration of the MP and EP containing 3

- decen

- 2

- one, it is in the best interest s of the public to issue the registration for AMV

- 1018 Technical and AMV

- 1018 EP. The basis for this decision can be found in the risk assessment for 3

- decen

- 2

- one , which is characterized in this BRAD. 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 3

- decen

- 2

- one pesticide products will cause harm or a disproportionate impact on at

- risk communities. For additional information regarding3 - decen - 2 - one Page 22 of 30 Biopesticides Registration Action Document environmental justice issues, please visit EPA’s website at http://www.epa.gov/compliance/environmentaljustice/index.html
. V I . ACTIONS REQUIRED BY REGISTRANTS EPA evaluated all data submitted in connection with the registration of the 3

- decen

- 2

- one 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 m ay 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 p esticide product. A brief summary 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 Additionally, all incidents of hypersensitivity (including both suspected and confirmed incidents) must be reported to the Agency under the provisions of 40 CFR Part 158.2050(d).
VI I . A PPENDIX A. DATA REQUIREMENTS (40 CFR P ART 158 - S UBPART 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 regi stration, there may be additional MRIDs that support registration of other products containing this active ingredient.3 - decen - 2 - one Page 23 of 30 Biopesticides Registration Action Document
TABLE 3 . Product Chemistry Data Requirements for 3 - decen - 2 - one ( 40 CFR § 158.2030 ) OCSPP Guideline Reference No./ Study Description of Result MRID 8 8 0. 1100 Product identity and composition The product identity and composition were adequately addressed. Confidential Business Information (CBI). 47942601 8 8 0. 1200 Description of starting materials, production, and formulation process The description of the starting materials, production, and formulation process were adequately addressed. CBI. 47942602 47942603 8 8 0. 1400 Discussion of formation of impurities The discussion of formation of impurities was adequately addressed. CBI. 47942604 8 3 0. 1700 Preliminary analysis The preliminary analysis of the product was acceptable. CBI. 47942605 8 3 0. 1750 Certified limits The certified limits listed on the CSF are acceptable. 47942606 8 3 0. 1800 Enforcement analytical method The enforcement analytical method was adequately addressed. CBI. 479426053 - decen - 2 - one Page 24 of 30 Biopesticides Registration Action Document
TABLE 4 . Physical and Chemical Properties for 3 - decen - 2 - one ( 40 CFR § 158.2030 ) OCSPP Guideline Reference No./Property Description of Result MRID 830.6302 Color Colorless to pale yellow 47942607 830.6303 Physical State Clear liquid 47942607 830.6304 Odor Pleasant 47942607 830.6313 Stability to normal and elevated temperatures, metals and metal ions The stability of the active ingredient of the test substance untreated and in presence of metals and metal ions (iron powder, iron acetate, aluminum powder, and aluminum acetate) stored for 1, 2, 7 and 14 days was

determined at ambient (21

- 23°C) and elevated temperature (54°C). A significant decrease in the conce ntration of the active ingredient was observed at elevated temperatures for all treatments and with the samples treated with iron acetate at ambient temperature after 7 days. 47942607

830.6315 Flammability Flash point = 91°C From Confidential Statement of Formula (CSF) 830.6317 Storage Stability Not required for TGAI. MP is stable during one year storage stability study. 48970301 830.6319 Miscibility N/A, not an emulsifiable liquid and is not to be diluted with petroleum solvents 47942607 830.6320 Corrosion Characteristics Not required for TGAI. MP showed no signs of corrosion (cracking, pitting, or discoloration) during one year storage stability study. 48970301
830.7000 pH 4.33 of 1% w/w suspension in water at 23°C 47942607 830.7050 UV/Visible light absorption pH λ max (nm) ε (L/mol*cm ) Neutral 229.0 14408.1 Acidic 229.0 16464.7 Alkaline 229.0 9330.6 47942607
830.7100 Viscosity 2.211 mm 2 /s at 25°C 48156401 830.7200 Melting Range N/A, not a solid 47942607 830.7220 Boiling Range 224.0°C 47942607 830.7300 Density/Relative Density/Bulk Density 0.845 g/mL at 20°C 47942607 830.7 520 Particle size, fiber length, and diameter distribution N/A, not insoluble in water and not a fiber 47942607 830.7550 Partition Coefficient (n

- Octanol/ 830.7560 Water) 830.7570 Log P ow = 3.45 47942607
830.7840 Water Solubility 0.140 g/L at 24°C 47942607 830.7950 Vapor Pressure 430 Pa at 25°C 479426083 - decen - 2 - one Page 25 of 30 Biopesticides Registration Action Document Table 5 : Mammalian Toxicology Data Requirements for 3 - decen - 2 - one (40 CFR § 158.2050) Study/ OCSPP Guideline No. Results Toxicity Category/Description MRID Acute oral toxicity (rat) (870.1100) LD 50 > 5,000 mg / kg body weight in female rats Toxicity Category IV 47942609 Acute dermal toxicity (rat) (870.1200) LD 50 > 5,000 mg / kg body weight in male and female rats Toxicity Category IV 47942610 Acute inhalation toxicity (rat) (870.1300) LC 50 0.52

- 2.04 mg/L in male rats and > 2.04 mg/L in female rats Toxicity Category III 47942611 Primary eye irritation (rabbit) (870.2400) One hour after test substance instillation, all three treated eyes exhibited corneal opacity and conjunctivitis, and two treated eyes exhibited iritis. Severity decreased over time, with all animals free of ocular irritatio n by Day 10. Test substance is classified as moderately irritating to the eye. Toxicity Category II 47942612
Primary dermal irritation (rabbit) (870.2500) Animals exhibited severe irritation (severe erythema and moderate edema) through 72 hours post patch removal. Irritation was no longer observed by Day 14. Test substance is classified as severely irritating to the skin. Toxicity Category II 47942613 Dermal sensitization (guinea pig) (870.2600) Not a dermal sensitizer.

- 47942614 90

- Day oral toxicity (870.3100) A subchronic 90

- day oral toxicity study (OCSPP 870.3100) on the active ingredient (a.i.) was not conducted. In lieu of the study, EPA used a WOE approach to estimate the likelihood of potential of toxicity from repeat oral exposure to this substance. First, using an expert system computer program (DEREK Nexus), EPA identified two potential toxicological endpoints for 3

- decen

- 2

- one (potential dermal sensitizat ion and in vitro chromosome damage); however, follow

- up studies did not support these as toxicological endpoints. Second, the metabolic pathways of 3

- decen

- 2

- one have been characterized and demonstrate that the biochemical is metabolized into innocuous co mpounds that are either excreted or further metabolized in the fatty acid pathway or citric acid cycle. Third, 3

- decen

- 2

- one occurs naturally in some foods and has been used as a food additive without specific reports of adverse effects. Finally, FDA has approved the use of 3

- decen

- 2

- one as a synthetic flavoring agent and adjuvant that may be directly added to food under 21 CFR § 172.515. Based on this evidence, EPA conclude d that 3

- decen

- 2

- one has relatively low toxicity via the repeated oral exposure r oute. - 47942617 48422301

90

- Day dermal toxicity (870.325 0) Not required. Proposed uses not to involve purposeful application to human skin and do not result in comparable human exposure to the product. - 47942617 90

- Day inhalation toxicity (870.3465 ) Not required. Repeated inhalation exposure is unlikely due to product being applied by a thermal fog generator in a closed system. Personnel are not allowed in the potato storage facilities during application and - 47942617; 484223013 - decen - 2 - one Page 26 of 30 Biopesticides Registration Action Document Table 5 : Mammalian Toxicology Data Requirements for 3 - decen - 2 - one (40 CFR § 158.2050) Study/ OCSPP Guideline No. Results Toxicity Category/Description MRID evacuation of the product. In addition, any unlikely inhalation exposure will be mitigated on the label by precautionary statements and PPE requirements. Developmental toxicity (870. 3700 ) Maternal and fetal NOAEL = 1,000 mg/kg/day (the highest dose tested)
. A lower bodyweight gain effect was seen in the highest

- dose group (1,000 mg/kg/day) for maternal rats; however, the bodyweight gain effect is considered to be attributable to the palatability of the test substance and not toxicologically significant. - 48970303

Mutagenicity

– Tier I (870.5100, 5300 and 5375)

Mutagenicity

– Tier II (870.5395) Test substance is negative in bacterial reverse mutation assay with and without metabolic activation
. Test substance positive in 24

- hr exposure without metabolic activation and equivocal results with metabolic activation in an in vitro mammalian gene mutation assay (mouse lymphoma cell). Mouse lymphoma results are considered equivocal because it is not cl ear whether the positive results would translate into an in vivo system based on the increased osmotic pressure and marked cytotoxicity noted during the experiment. Test substance is considered non

- mutagenic based on in vivo mammalian erythrocyte micronuc leus test assay results. - 47942616

47942615

48412402

Table 6 : Nontarget Organism Toxicity Data Requirements for 3 - decen - 2 - one (40 CFR § 158.2060) Study/ OCSPP Guideline No. Results Toxicity Category/Description MRID Avian acute oral toxicity (850.2100) Not required. S ignificant exposure to birds is not expected due to the proposed indoor use

only as a sprout inhibitor on potatoes. In addition, 3

- decen

- 2

- one is applied and released as a vapor and is not expected to be available to birds via the oral route. Significant exposure not expected 47942617 Avian dietary toxicity (850.2200) Not required. S ignificant exposure to birds is not expected due to the proposed indoor use

only as a sprout inhibitor on potatoes. In addition, 3

- decen

- 2

- one is applied and released as a vapor and is not expected to be available to birds via the oral route. Significant exposure not expected 47942617 Aquatic invertebrate acute toxicity , freshwater (850.1010) Not required. S ignificant exposure to aquatic invertebrates is not expected due to the proposed indoor use only as a sprout inhibitor

on potatoes. In addition, 3

- decen

- 2

- one is applied and released as a vapor and is not expected to enter surface water in amounts sufficient to impact aquatic li fe. Significant exposure not expected 479426173 - decen - 2 - one Page 27 of 30 Biopesticides Registration Action Document Table 6 : Nontarget Organism Toxicity Data Requirements for 3 - decen - 2 - one (40 CFR § 158.2060) Study/ OCSPP Guideline No. Results Toxicity Category/Description MRID F ish acute toxicity, freshwater (850.1075) Not required. S ignificant exposure to fish is not expected due to the proposed indoor use

only as a sprout inhibitor on potatoes. In addition, 3

- decen

- 2

- one is applied and released as a vapor and is not expected to enter surface water in amounts sufficient to impact aquatic life. Significant exposure not expected 47942617
Terrestrial plant toxicity, Seedling emergence/Vegetative vigor (850.4 1 00 and 850.4150 ) Not required. S ignificant exposure to terrestrial plants is not expected due to the proposed indoor use only as a sprout inhibitor

on potatoes. In addition, 3

- decen

- 2

- one is applied and released as a vapor during winter months when terrestrial plants are gene rally dormant and when seedlings are not emerging. Significant exposure not expected 47942617
Nontarget insect testing (880.4350) Not required. S ignificant exposure to insects is not expected due to the proposed indoor use only as a sprout inhibitor on potatoes. In addition, 3

- decen

- 2

- one is applied and released as a vapor during winter months when nontarget insects are generally dormant. Significant exposure not expected 47942617

VIII. A PPENDIX B . For product specific information, please refer to http://www.epa.gov/pesticides/pestlabels . IX . APPENDIX C. REFERENCES JECFA
. 2003. Joint FAO/WHO Expert Committee on Food Additives. WHO Food Additives Series 50. Secondary alcohols, ketones and re lated esters. International Programme on Chemical Safety. Munro, I. and B. Danielewska

- Nikiel. 2006. Comparison of estimated daily intakes of flavoring substances with no

- observed effect levels. Food and Chemical Toxicology. Vol. 44: 758

- 809. Patrignani , F., P. Burns, D. Serrazanetti, G. Vinderola, J. Reinheimer, R. Lanciotti, and M.E. Guerzoni. 2009. Suitability of high pressure

- homogenized milk for production of probiotic fermented milk containing Lactobacillus acidophilus . J. Dairy Research. Vol. 76: 74

- 82. Oser B.L. and R.A. Ford
. 1978. Recent progress in the consideration of flavoring ingredients under the Food Additives Amendment. 11. GRAS Substances. Food Technology. Vol. 32 (2): 60

- 70.3 - decen - 2 - one Page 28 of 30 Biopesticides Registration Action Document O tt A., A. Hugi, M. Baumgartner and A. Chaintreau. 2000. Sensory investigation of yogurt flavor perception: mutual influence of volatiles and acidity. J. Agric. Food Chem. Vol. 48: 441

- 450. U.S. EPA. 2011. Exposure Factors Handbook 2011 Edition (Final) (EPA/600/R

- 09/052F). U.S. Environmental Protection A gency, Washington, DC. REVIEWS AND OTHER REFERENCES EPA. 2010. Memorandum from Gina M. Casciano and Colin G. Walsh thru Russell S. Jones to Driss Benmhend. Revised Hazard Assessment for Tier I Human Health Toxicity in Support of the Registration of AMV

- 1018 Technical , Containing 3

- decen

- 2

- one as its Active Ingredient (Amends EPA Memorandum from G. Casciano and C. Walsh through R. Jones to D. Benmhend dated June 16, 2010). U.S. Environmental Protection Agency Office of Pesticide Programs. December 7, 2010
. EPA. 201 1 . Memorandum from Colin G. Walsh thru Angela L. Gonzales to Linda A. Hollis. Joint Science Review with Health Canada Pest Management Regulatory Agency (PMRA) in Support of the Registration of AMV

- 1018 Technical (EPA File Symbol No. 5481

- LAI), a Manufacturi ng - Use Product (MP), Containing 98.0% of 3

- decen

- 2

- one as its Active Ingredient and Tolerance Exemption Petition Review in Support of 3

- decen

- 2

- one. U.S. Environmental Protection Agency Office of Pesticide Programs. December 20, 2011. EPA. 201 3 . Memorandu m from Angela L. Gonzales thru Felecia A. Fort to Colin G. Walsh
. Joint Science Review with Health Canada Pest Management Regulatory Agency (PMRA) in Support of the Registration of AMV

- 1018 Technical Containing 98.0% of 3

- Decen

- 2

- One as its Active Ingredie nt . U.S. Environmental Protection Agency Office of Pesticide Programs. January 3, 2013
. X. GLOSSARY OF ACRONYMS AND ABBREVIATIONS a.i. a ctive i ngredient AMVAC Amvac Chemical Corporation BPPD Biopesticides and Pollution Prevention Division BRAD Biopesticide Registration Action Document bw body weight CBI Confidential Business Information CFR Code of Federal Regulations CIPC Chlorpropham 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 expressed3 - decen - 2 - one Page 29 of 30 Biopesticides Registration Action Document as a concentration in air or wate r (e.g. mg/L). EDSP Endocrine Disruptor Screening Program EDSTAC Endocrine Disruptor Screening and Testing Advisory Committee EFH Exposure Factors Handbook EP end

- use product EPA Environmental Protection Agency (the “Agency”) FDA Food and Drug Administrati on FEMA Flavor and Extract Manufacturer’s Association 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 JECFA Joint FAO/WHO Expert Committee on Food Additives kg kilogram Kow octanol

- water partition coefficient L liter LC 50 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)
. 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 nanometer NOAEL no - observed

- adverse

- effect

- level NOEL no - observed

- effect

- level NOF notice of filing NOR notice of receipt OPP Office of Pesticide Programs O CSPP Office of Chemical Safety and Pollution Prevention pa pascal PADI possible average daily intake PMRA Canada’s Pesticide Management Regulatory Authority PPE personal protective equipment PR Notice Pesticide Registration Notice3 - decen - 2 - one Page 30 of 30 Biopesticides Registration Action Document TGAI technical grade of the active ingredient TSG Technology Sciences Group, Inc. ug microgram USDA United States Department of Agriculture UV ultra

- violet WOE weight of the evidence