# . ~ .
Polyoxin D Zinc Salt (PC Code: 230000) Preliminary Work Plan and Summary Document Registration Review: Initial Docket

June 2014

Case 6076

Approved by:

Robert McNally, Director Biopesticides and Pollution Prevention Division
Date: 

# 61 20 ~~Polyoxin D Zinc Salt EPA- H Q-O P P-2014-0108 www.regulations.gov

TABLE OF CONTENTS

I. 

### PRELIMINARY WORK PLAN ...................................................................................................... 4

A. Overview .................................................................................................................................... 4

B. Statutory and Regulatory Authority ....................................................................................... 4

C. Background and Regulatory Information .............................................................................. 5

D. Tolerance Actions .................................:....................................................................................7 E. AnticiPated Data Needs and Risk Assessments ...................................................................... 8

F. Risk to Threatened and Endangered Species ........................................................................11

G. Incidents ...................................................................................................................................12

H. Timeline ...................................................................................................................................13

I. Guidance for Commenters .............................:.......................................................................13 II. 

### BIBLIOGRAPHY ...........................................................................................................................16 A. U.S. EPA 2008. Risk Assessment Memorandum .................................................................16 B. U.S. EPA 1997. Polyoxin D Zine Salt (230000) Registration Eligibility Document. .........16 C. Studies Submitted to the Agency in Support of Registration of Polyoxin D Zinc Salt ..... 16

2Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.i

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### ACRONYMS AND ABBREVIATIONS

BPPD The EPA's Biopesticides and Pollution Prevention Division 40 C.F.R. Title 40 of the Code of Federal Regulations DCI Data Call-In EDSP Endocrine Disruptor Screening Program EPA U.S. Environmental Protection Agency FFDCA Federal Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act FR Federal Register FWP Final Work Plan IDS Incident Data System MRID No. Master Record Identification Number: The EPA's system of recording and tracking studies submitted to the

Office of Pesticide Programs. MRL Maximum Residue Limit OPP The EPA's Office of Pesticide Programs PC Code Pesticide chemical code: a six-digit number assigned by OPP to identify pesticide chemicals. PWP Preliminary Work Plan TGAI Technical grade of the active ingredient TMDL Total Maximum Daily Load US United StatesPolyoxin D Zinc Salt EPA-HQ-OPP-2014-0108

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I. PRELIMINARY WORK PLAN A. Overview The docket for polyoxin D zinc salt (Case 6076) is now open, initiating the first public comment period for this registration review case (docket number EPA-HQ-OPP-2014-0108). Seven products containing polyoxin D zinc salt are currently registered for use on food crops, turf and ornamentals to control and/or suppress fungal diseases of plants. This preliminary work plan (PWP) explains what the U.S. Environmental Protection Agency's (referred to as EPA or Agency in this document) Office of Pesticide Programs (OPP) knows about polyoxin D zinc salt, highlights its anticipated data and assessment needs, identifies types of information that would be especially useful in conducting the review, and provides an anticipated timeline for completing the registration review process for polyoxin D zinc salt. The registration review process was designed to include a public participation component, and by sharing this information in the docket, EPA intends to inform the public of what it knows about polyoxin D zinc salt and what types of new data or other information would be helpful to receive as it moves toward a decision on this biochemical pesticide. The EPA encourages all interested stakeholders toreview the PWP and to provide comments and additional information that will help the EPA's decisionmaking process for polyoxin D.zinc salt. In addition to general areas on which persons may wish to comment, there are some areas identifted in the PWP about which the EPA specifically seeks comments and information. Interested stakeholders could include the following: environmental noriprofit or interest groups; pesticide manufacturers; agricultural labor or commodity groups; commercial, institutional, residential, and other users of pesticides; or the public at large. The PWP begins by describing the statutory and regulatory authorities for registration review. Next, it provides background information on polyoxin D zinc salt, which includes a description of its mode of action, the currently registered pesticide products, application rates and methods, use sites, and its tolerance exemption. Then, it lists the anticipated data needs, risk assessments, and a projected registration review timeline for this case. Finally, the PWP provides guidance for commenters, explains the next steps EPA will be taking, summarizes background information, and lists supporting studies, risk assessments, and other documents available for the registration review of polyoxin D zinc salt. Further information about this case, including background and supporting documents, is available at http://www.regulations.Qov (under "SEARCH for: Rules, Comments, Adjudications or Supporting Documents," enter the docket identification number, which is indicated above).
B. Statutory and Regulatory Authority The Food Quality Protection Act (FQPA) of 1996 mandated a Registration Review Program. All pesticides distributed or sold in the United States (US) must generally be registered by the EPA, based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on the product labeling. The Registration Review program is 4Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.regutations.gov intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continue to meet the statutory standard of no unreasonable adverse effects to human health or the environment. Changes in science, public policy, and pesticide use practices will occur over time. Through its Registration Review Program, the EPA periodically reevaluates pesticides to make sure that, as change occurs, products in the marketplace can continue to be used safely. Information on this program is provided on the EPA's website. The EPA is implementing the Registration Review Program pursuant to Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) section 3(g) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA standard for registration. The regulations governing registration review begin at 40 C.F.R. § 155.40. The EPA will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened for each case. The docket is the EPA's opportunity to state what it knows about the pesticide and what additional risk analyses and data or information it believes are needed to make a registration review decision. After reviewing and responding to comments and data received in the docket during this initial comment period, the EPA will develop a final work plan (FWP) and the anticipated schedule for the registration review of polyoxin D zinc salt. C. Background and Regulatory Information i. Summary of the Active Ingredient, Usage, and Associated Pesticide Products Polyoxin D Zinc Salt is derived from Streptomyces cacaoi var. asoensis, a soil-borne bacterium isolated in Japan, and was first registered for pesticidal use in the United States on August 20, 1997 to control fungal diseases of turf and ornamentals. The active ingredient is produced by a fermentation process with the naturally occurring microorganism. The active portion of polyoxin D zinc salt is polyoxin D, a highly water-soluble compound; the zinc salt increases the residual time of the pesticide on plant surfaces. The uses of polyoxin D zinc salt were expanded on November 19, 2008 to the following food crops: almonds, cucurbit vegetables, fruiting vegetables, ginseng, grapes, pistachios, pome fruits, potatoes, and strawberries. Polyoxin D does not kill the pathogenic fungi; its pesticidal mode of action is to inhibit the growth of chitin in the fungal cell wall by competitively inhibiting the enzyme, chitin synthetase. Without chitin, the growth of the targeted fungi is halted, as is the pathogen's ability to infect its host plant's cells. Polyoxin D no longer acts as a fungicide when it has degraded or washed off plant surfaces. Since polyoxin D is specific to fungal species, other organisms (bacteria, viruses, plants, insects, and animals) are not affected. The following tables provide information known to the Agency about polyoxin D zinc salt:Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.regulations.gov

Table 1. Chemical Facts for Polyoxin D Zinc Salt PC code 230000 Case Number 6076 CAS Number 146559-78-1 Year first re istered 1997 Pesticide Type Fun icide Chemical class Biochemical Reregistration Eligibility Decision RED) Not applicable, since polyoxin D zinc salt was registered after November 1984, it was not subject to re istration. Tolerance Reassessment Eli ibilit Decision TRED) Not applicable, since a tolerance exemption for polyoxin D zinc salt was first established in 2008.' It will be reassessed as part of this re istration review. Cumulative group Not applicable 40 CFR Citation 40 CFR § 180.1285: Exem tion from the re uirement for a tolerance. Non- esticidal uses Not applicable

Table 2. Polyoxin D zinc salt Use and Usage Information Z Summary of Use Polyoxin D zinc salt is registered for use as a foliar spray on food crops, turf, and ornamentals to control and/or suppress fun al diseases of plants. Use Sites Golf courses, home lawns, parks, and commercial and institutional grounds. Summary of Usage 1) Sod for sale or other commercial use; 2) commercial seed production; 3) research. Formulation Types Wettable powder, water dis ersible granules, and sus ension concentrate. Application Metltod(s) Products can be applied by handheld or mechanical s ra ers. Technical Re istrant Karen Pharmaceutical CO. LTD No. of Re istrations 7 Restricted Use No

1 Under the Food Quality Protection Act (FQPA), EPA was directed to review the safety of all existing tolerances (inaxinium

~ esticide residue liinits on tood) that were in effect as of August 1996. In September 2007, EPA completed the last of 9,721 required tolerance reassessment decisions. z Refer to the Usage Report fn Support of a Regfstratfon Revfew for Polyoxfn D zfnc salt (230000) in the registration review docket for more details.Polyoxin D Zinc Salt EPA-H Q-OPP-2014-0108
www. regitlations.gov

; Table 3. Information About the Currently Registered Polyoxin D Zinc Salt Pesticide Products ~ I EPA Product I\iame i Registration °

(/O Active Ingredient; Date Application Rates Application Use Sites l

~ iumber i i Formulation Type) Registered Methods
I i T'urf (golf courses, ENDORSETM (2.5% a.i.; September residential lawns, 66330-41 wettable powder) 24, 2002 0.275 Ib a.i./A Foliar parks, commercial and institutional rounds Chemiaation Outdoor ENDORSETM Water February 3, Up to 3 applications
~ (sprinklers or agricultural crops, 66330-56 Dispersible Granules 2014 (2.1 oz a.i./A) per drip irrigation) greenhouse,

(11.3%; granular) season nurseries Not applicable; Golf courses, product is for residential lawns, 68173-1 Polyoxin D Zinc Salt ° August 29, pesticide ' Not alicable pp p arks and Technical (23.8 /o a.i.) 2012 manufacturing commercial and purposes only institutional ounds Golf courses, ENDORSE Wettable residential lawns, 68173-2 Powder Fungicide (2.5% April 28, 0.03 - 0.275 lb a.i./A Foliar parks and

a. i.) 2009 commercial and institutional rounds ENDORSE Water February 12, 3.5 oz a.i./A Chemigation Commercial 68173-3 Dispersible Granules 2414 < 5 times/season (sprinklers or indoor food use

(11.3% a.i.) drip irrigation) 3.75 fl oz product/A Ground or aerial Veggieturbo 5SC (preventative); 6.5 to spray, soil 68173-4 Suspension Concentrate April 26, 13.0 fl oz/A (high drench, or Commercial

Fungicide (5% a.i.) 2013 disease pressure or chemigation outdoor food use stand-alone (sprinklers or a lications) drip irri ation)

Foliar spray 70051- 1 I6 Novel 0.5% SC Fun°icide b March 5 5 fl oz/• ' 1. g al water 2 gal mix/1,000 ft 2 of (hand pump

sprayer, garden Commercial (0.5% a.i.) 2014 outdoor food use treatment area sprayer, mister,

or other s rayer)Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108
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D. Tolerance Actions Polyoxin D zinc salt is exempt from the requirement of a tolerance as follows: 40 C.F.R. $ 180.1285: Polyoxin D zinc salt; exemption from the requirement of a tolerance. An exemption from the requirement of a tolerance is established for the residues of polyoxin D zinc salt in or on all food commodities when applied as a fungicide and used in accordance with good agricultural practices. 

### Federal Regi.ster Citation: Final Rule (77 FR 56133, September 12, 2012).
E. Anticipated Data Needs and Risk Assessments Provided below are tables of the current data requirements for biochemical pesticides as set forth in 40 CFR § 158, subpart U. They are arrayed by scientific discipline (i.e., product chemistry, human health assessment, and non-target organisms and environmental fate), and descriptions are included regarding how the data requirements have been fulfilled or where data have been waived. At this time, no data gaps (anticipated data needs) for polyoxin D zinc salt have been identified. The most recent comprehensive risk assessment for polyoxin D zinc salt was completed in September, 2012 in support of amending the tolerance exemption for polyoxin D zinc salt to include all food commodities. Because there are no data gaps for polyoxin D zinc salt, the Agency does not anticipate the need to conduct a new risk assessment during registration review.

i. Product Analysis ( 

### 40 C.F.R. & 158.2030)

Table 4. Summary of Product Analysis Data for Polyoxin D Zinc Salt Harmonized Guideline Data Requirement Has Data Requirement MRID No. or Other Been Addressed? How? Source Number 880.1100 Product Identity and Composition Yes

— Study 43261809

Description of Staring Materials, Production, 880.1200 and Formulation Process Yes

— Study .43261809 880.1400 Discussion of Formation of Impurities Yes

— Study 43261809 830.1700 Preliminary Analysis Yes

— Study 43261811 830.1750 Certified Limits Yes

— Study 43261809 43261811 43261812 830.1800 Enforcement Analytical Method Yes

— Study 43261813 43261814 43261815

8Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108

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Table 5. Summary of Physical and Chemical Characteristics for Polyoxin D Zinc Salt Harmonized Has Data Requirement Been MRID No. or Guideline Data Requirement Number Addressed? How? Other Source 830.6302 Color Yes

— Study 43261816 830.6303 Physical State Yes

— Study 43261816 830.6304 Odor Yes

— Study 43261816 830.6313 Stability to Normal and Elevated Yes

— Study 43261819

Temperatures, Metals and Metal Ions 830.6315 Flammability Not applicable; data are not required for technical grade active ingredients. 830.6317 Storage Stability Not applicable; data are not required for technical grade active ingredients. 830.6319 Miscibility Not applicable; data are not required for technical grade active ingredients. 830.6320 Corrosion Characteristics Yes

— Study 43261820 830.7000 pH Yes

— Study 43261816 Absorption maxima: 270 nm under neutral conditions, 830.7050 UV/Visible Light Absorption 274 nm under acidic 48653302 conditions, 268 nm under alkaline conditions 830.7100 Viscosity Not applicable; TGAI is a solid at room temperature 830.7200 Melting Point/Melting Range Yes

— Study 43261816 830.7220 Boiling Point/Boiling Range Not applicable; TGAI is solid at room temperature 830.7300 Density/Relative Density/Bulk Density Yes

— Study 43261816 (Specific Gravity) Particle Size, Fiber Length, and Diameter Not applicable; TGAI is not water insoluble and is not 830.7520 Distribution fibrous 830.7550 Not applicable; TGAI is polar substance and very 830.7560 Partition Coefficient (n-Octanol Water) water soluble 830.7570 830.7840 Water Solubility Yes

— Study 43261816 830.7950 Vapor Pressure Not Applicable. TGAI is a saltPolyoxin D Zinc Salt EPA-HQ-OPP-2014-0108
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ii. Human Health Assessment ( 

### 40 C.F.R. 4 158.2050)

Table 6. Sumniary of Iduman Ilealth Assessment Data for Polyoxin D Zinc Salt Harmonized Has Data Requirement MRID No. or Other Guideline Data Requirement Been Addressed? How? Source Number 870.1100 Acute Oral Toxicity

- Rat Yes

— Study 43261 823 870.1200 Acute Dermal Toxicity Yes

— Study 43261825 870.1300 Acute Inhalation Toxicity

— Rat Yes

— Study 43261827 870.2400 Primary Eye Irritation Yes

— Study 43261829 870.2500 Primary Dermal Irritation Yes

— Study 43261831 870.2600 Dermal Sensitization Yes

— Studies 43261833 None have been reported, but any occurrence must be None Hypersensitivity Incidents reported as an adverse incident. 870.7800 Immunotoxicity Yes

- Study 47120901 870.3100 90-Day Oral (one species) Yes

— Data Waiver U.S. EPA, 2000 870.3250 90-Day Dermal

— Rat Yes

— Data Waiver U.S. EPA, 2000 870.3465 90-Day Inhalation

— Rat Yes

— Data Waiver U.S. EPA, 2000 870.3700 Prenatal Developmental

— Rat Preferably Yes

— Study 43261837 870.4100 Chronic Toxicity Yes

— Studies 43261838 43261839 870.4200 Carcinogenicity Yes

— Studies 43261838 43261839 870.5100 Bacterial Reverse Mutation Assay Yes

— Study 43323001 870.5300 In vitro Mammalian Cell Assay Yes

— Study 43261835 870.5375
iii. Nontarget Organisms and Environmental Fate 

### (40 C.F.R. 4 158.2060)

Table 7. Summary of Nontarget Organism Data for Polyoxin D Zinc Salt Harmonized Data Requirement Has Data Requirement Been MRID Guideline Number Addressed? How?
850.2100 Avian Acute Oral Toxicity Yes

- Study 43261840 43261841 850.2200 Avian Dietary Toxicity Yes

— Data Waiver U.S. EPA, 1997 850.1075 Fish Acute Toxicity, Freshwater Yes

- Study 43261842 850.1010 Aquatic Invertebrate Acute Toxicity, Yes

- Study 43261843 Freshwater 10Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.regulations.gov

Table 7. Summary of Nontarget Organism Data for Polyoxin D Zinc Salt Harmonized Data Requirement Has Data Requirement Been MRID Guideline Number Addressed? How?
850.1010 Aquatic Invertebrate Acute Toxicity, Yes

- Study 43261843 Freshwater 850.4100 Terrestrial Plant Toxicity, Seedling Yes--Data Waiver U.S. EPA, 2000 Emergence 850.4150 Terrestrial Plant Toxicity, Vegetative Yes--Data Waiver U.S. EPA, 2000 Vigor 880.4350 Nontarget Insect Testing Yes

- Study 43261844
E. Risk to Threatened and Endangered Species Nontarget organism studies indicated that there was no toxicity to mammals and birds when exposed to polyoxin D zinc salt at very high doses (mammalian acute oral toxicity LD50 > 10,000 mg/kg (laboratory rats); mammalian 90 day oral toxicity NOAEL (female rats) and LOAEL (male rats) = 20,000 ppm; avian acute oral toxicity LD50 > 2150 mg/kg (mallard duck); and avian dietary LC50 > 5000 ppm (mallard duck)). 3 Nontarget terrestrial insects were unaffected by exposure to the active ingredient at > 400 ppm, and this is approximately lOx the highest expected residue level when polyoxin D zinc salt is applied at the maximum labeled use rate. Nontarget plants are not expected to be affected since polyoxin D is a fungal chitin synthetase inhibitor and plants do not possess this enzyme. Polyoxin D zinc salt was moderately toxic to both freshwater fish (96 hour LC50 = 5.06 ppm) and freshwater invertebrates (LC50 = 1.35 ppm) in laboratory studies; 4 however, based on the application rates and the use patterns of the registered products, the aquatic EEC is 1.6 ppb, 3 well-below the LOCs for nontarget aquatic organisms. Consequently, adverse effects to terrestrial and aquatic species are expected to be negligible and the effects determination for endangered/threatened species and designated critical habitat is a"No Effect." EPA anticipates conducting no further analysis of potential risks to endangered or threatened species, unless data or information are obtained during the registration review process that would indicate such an assessment would be needed to inform the Agency's decision.

3 U.S.EPA 2008. ° U.S.EPA 1997. The Estimated Environmental Concentration (EEC) for aquatic organisms is approximately 1.6 ppb based on the Generic Estimated Environmental Concentration (GENEEC) model, and the terrestrial EECs range fromapproximately 9 ppm to 62 ppm on foliage (depending on the plant type), based on the Terrestrial Residue Exposure (TREX) model.Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.regulations.gov



### F. Endocrine Effects As required by the Administrator under the Federal Food, Drug, and Cosmetic Act (FFDCA) section 408(p), the EPA has developed the Endocrine Disruptor Screening Program (EDSP) and has begun to implement the screening program that is to be used to test all pesticides in order to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a"naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." FFDCA section 408(p)(4) authorizes the Administrator, by order, to exempt from the requirements of the Estrogenic Substances Screening Program a biologic substance or other substance if a determination is made that the substance is not anticipated to produce any effect in humans similar to an effect produced by a naturally occurring estrogenic substance. Between October 2009 and February 2010, the EPA issued test orders/data call-ins for the first group of 67 chemicals, which contained 58 pesticide active ingredients and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 14, 2013, 5 and includes some pesticides scheduled for registration review and chemicals found in water. Polyoxin D zinc salt is not among the group of pesticide active ingredients on the lists to be screened under the EDSP. The EPA, as part of this PWP, believes that polyoxin D zinc salt is a substance that would not likely produce any effect in humans similar to an effect produced by a naturally oceurring estrogenic substance. As such, pursuant to Section 408(p) (4), the EPA will determine in the future whether it can exempt polyoxin D zinc salt from the requirements of the Section 408(p) EDSP. In the event the EPA does determine to exempt this substance from the EDSP, an order will be issued. For further information on the status of the EDSP, the policies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website at http: //ivumw. epa. gov/endoA 

### G. Incidents From March 17, 1998 through January 29, 2014, OPP's Incident Data System (IDS) indicates two minor human incidents from the use of pesticide products containing polyoxin D zinc salt as their active ingredient. There were no reported incidents to domestic animals, drinking water, surface water, groundwater, plants, wildlife or other non-targets. A search of OPP's Environmental Incident Information System (EIIS) on June 26, 2014 revealed no incidents associated with polyoxin D zine salt. The database contains information dating back to the 1970s. The EPA will consider any incident data or comments submitted in response to this PWP.

5 See http•//www regulations go

~ d#!(locunicnt[)etail:D=[?['A-1IU-OPP`I'-2UU9-U477-OU74 for the second list of chemicals. 12Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.regulatfons.gov
Below is the projected timeline for registration review of case 6076: Polyoxin D zinc salt. Activities Estimated Month/Year Opening the Docket Open Docket and 60-Day Public Comment Period for September 2014 Close Public Comment Period November2014 ase Development ssue Final Work Plan March 2015 ssue Data Call-in /A ata Submission /A Open 30-Day Public Comment Period for Draft Risk Assessments /A lose Public Comment Period /A egistration Review Decision pen 60-Day Public Comment Period for Proposed Registration eview Decision September 2015
lose Public Comment Period November2015 inal Decision March, 2016 *Estimated Total (years) 1 year and 6 months * This schedule is subject to revision should unforeseen issues arise during the registration review process. In the event an issue arises, such as the failure to acquire an EDSP exemption, an amended Final Work Plan will be issued at that time. That Final Work Plan will identify any newly anticipated data needs and set forth a new timeline.
I. Guidance for Commenters The public is invited to comment on the EPA's PWP and rationale. The areas below highlight topics of special interest to the EPA where comments, information and data, or reference to sources of additional information could be of particular use. The EPA will consider all comments, as well as any additional information or data provided in a timely manner, prior to issuing a Final Work Plan for this case.

13Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.regulations.gov► Confirmation on the following label information: 

### - Sites of application - Formulations - Application methods and equipment - Maximum application rates - Frequency of application, application intervals, and maximum number of applications - Geographic limitations on use► Use distribution (e.g., acreage and geographical distribution of relevant use sites)► Median and 90 t " percentile reported use rates (lbs active ingredient/1,000 square feet) from usage data — national, state, and county► Application timing (date of first application and application intervals) — national, state, and county► Usage/use information for non-agricultural uses► Typical application intervals (days)► State or local use restrictions► Foreign technical registrants not listed above who supply technical polyoxin D zinc salt to the US market i. Environmental Justice The EPA seeks to achieve environmental justice, the fair treatment and meaningful involvement of all people, regardless of race, color, national origin, or income, in the development, implementation, and enforcement of environmental laws, regulations, and policies. To help address potential environmental justice issues, the EPA seeks information on any groups or segments of the population who, as a result of their location, cultural practices, or other factors, may have unusually high exposure to polyoxin D zinc salt, compared to the general population. Please eomment if you are aware of any subpopulations that may have atypical, unusually high exposure compared to the general population.

ii. Water Quality Polyoxin D zinc salt is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act. In addition, no Total Maximum Daily Loads (TMDLs) have been developed for polyoxin D zinc salt. More information on impaired water bodies and TMDLs can be found at the EPA's website. 6 The EPA invites submission of water quality data for pesticides containing polyoxin D zine salt as an active ingredient. To the extent possible, data should conform to

6 http://www.epa.gov/owow/tmdl/. 14Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108

www. regulations.gov the quality standards in Appendix A of the Office of Pesticide Program's (OPP) Guidance for Submission of State and Tribal Water Quality Monitoring Data, March 2014: Inclusion of Impaired Water Body and Other Water Quality Data in OPP's Registration Review RiskAssessment and Management Process 3 to ensure they can be used quantitatively or qualitatively in pesticide risk assessments.

iii. Trade Irritants Through the registration review process, the EPA intends to solicit information on trade irritants and, to the extent feasible, take steps toward facilitating irritant resolution. The EPA will work to harmonize tolerance and international Maximum Residue Limits (MRLs), and, if necessary, may modify tolerance levels to do so. Growers and other stakeholders are asked to comment on any trade irritant issues resulting from lack of MRLs or disparities between U.S. tolerances and MRLs in key export markets, providing as much specificity as possible regarding the nature of the concern. Pesticidal food-use of polyoxin D zinc salt is covered under an existing exemption from the requirement of a tolerance. Moreover, there are no known MRLs for polyoxin D zinc salt. Therefore, the EPA does not anticipate that current uses of polyoxin D zinc salt will pose concerns as trade irritants. J. Next Steps After the 60-day comment period closes, the EPA will review and respond to any comments received in a timely manner, then issue a final work plan for case 6076: polyoxin D zinc salt.

15Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0 I 08

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### II. BIBLIOGRAPHY A. U.S. EPA 2008. Risk Assessment Memorandum from R. Jones, U.S. Environmental Protection Agency to C. Pfeifer, Regulatory Action Leader: "Tolerance Exemption Petition (PP# 71 7 7252) for Polyoxin D Zinc Salt (Chemical No. 230000), an old Active Ingredient in or on All Food Commodities to Control Plant Diseases and Pathogens (Food/Feed Use)," August 18, 2008. B. U.S. EPA 1997. Polyoxin D Zinc Salt (230000) Registration Eligibility Document. U.S. Environmental Protection Agency (U.S. EPA). Issued August, 1997. Available at: http://www.epa.gov/opp00001 /chem_search/reg_aetions/registration/related_PC-230000_ 1- Jul-03.pdf C. Studies Submitted to the Agency in Support of Registration of Polyoxin D Zinc Salt:

-- 

### MRID ---- 

### Citation -- 

### Receipt Date

r-- —



### Kaken Pharmaceutical Co., Ltd. (1994) Submittal of Efficacy, Product 27-May- 43261800 Chemistry, Toxicity and Environrnental Effect Data in Support of Experimental 1994

~ 

### Permit for STOPIT Wettable Powder Turf Fungicide. Transmittal of 44 studies.

Stewart, P. (1994) Results of University Trials Evaluating Polyoxorim for 27-May- 43261801 Control of Turf Diseases 1990-1993. Unpublished study prepared by Kaken 1994

Pharmaceutical Co.,Ltd. 26 p. Takahashi, K. (1972) Minimum Inhibitory Concentrations (MIC) of Polyoxins 27-May- 43261802 Against Bacteria, Yeast and Fungi. Unpublished study prepared by Kaken 1994

Chemical Co., Ltd. 5 p. I 

### Sasaki, S.• Ohta, N.; Yamaguchi, 1. et al. (1968) Studies on Polyoxin Action , 27-May- 43261803 Part I: Effect on Respiration and Synthesis in Protein, Nucleic Acids and Cell- 1994



### — - 

## ~ Wall of Fungi. Nippon Nogeikagaku Kaishi 42(10):633-638.

~ 

### ------ - --- l Hori, M.; Kakiki, K.; Suzuki, S. et al. (1971) Studies on the Mode of Action of 43261804 Polyoxins Part III: Relation of Polyoxin Structure to Chitin Synthetase 27-May1994



# ~ Inhibition. Agr. Biol. Chem., 35(8):1280-1291.

~ r! 

### 43261805 Hori, M.; Kakiki, K.; Misato, T. (1974) Interaction Between Polyoxin and 

# I 27-May-

~

~ 

### Active Center of Chitin S nthetase. A r. Biol. Chem 38 4:699-705.



### Y g O 

# I ;1994



### 16Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108

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### Hori, M.; Kakiki, K.; Misato, T. (1974) Further Study on the Relation of 27-May- 43261806 Polyoxin Structure to Chitin Synthetase Inhibition. Agr. Biol. Chem. 38(4):691- 1994

~ 698.


### 43261807 Misato, T. (1967) Mode of Action of Agricultural Antibiotics Developed in 27-May

### I Japan. Residue Reviews 25:93-104. 1994

Endo, A.; Misato, T. (1969) Polyoxin D, A Competitive Inhibitor of UPD-N- 27-May- 43261808 Acetylglucosamine: Chitin N-Acetylglucosaminyltransferase in Neurospora 1994 

### ~ i 

### crassa. Biochemical and Biophysical Research Communications 37(4):98-102. 

### ~

Hori, M. (1994) Polyoxin D Zinc Salt Technical and Polyoxin Z Wettable 43261809 Powder: Product Identity, Manufacturing Process, Unintentional Ingredients 27-Mayand Certified Limits. Unpublished study prepared by Kaken Pharmaceutical 1994 Co., Ltd. 21 p.

~ 

### Isono, K.; Asahi, K.; Suzuki, S. (1969) Studies on Polyoxins, Antifungal 27-May- 43261810 Antibiotics Part VII: The Structure of Polyoxins. Journal of the American 1994

Chemical Society 91(26):63-78. Kurose, T.; Muramatsu, J. (1994) Polyoxin D Zinc Salt Technical Grade Active



### ~ 43261811 Ingredient: Analysis of Samples: Lab Project Number: KPFT-93-0004: KPQC- 27-May93-0002. Unpublished study prepared by Institute of Fermentation Technology 1994 ' and Kaken Pharmaceutical Co., Ltd. 88 p.

Herzig, R.; Bussard, J. (1994) Validation of HPLC Analytical Method of 27-May- 43261812 Polyoxin D Zinc Salt: Lab Project Number: 41062. Unpublished study prepared 1994

by ABC LAB., Inc. 123 p. Kurose, T. (1993) HPLC Analytical Method of Polyoxin D Zinc Salt: Lab 27_May- 43261813 Project Number: KPFT-93-0001: KPD-93-008. Unpublished study prepared by 1994

Kaken Pharmaceutical Co., Ltd. 19 p. Kurose, T. (1994) The Validity of HPLC Analytical Method of Polyoxin D 

### ~ a ~ y 

### j 43261814 Zinc Salt: Lab Project Number: KPFT-93-0002: KPD-93-009. Unpublished 1994 

### ~ study prepared by Kaken Pharmaceutical Co., Ltd. 77 p. I

Muramatsu, J. (1993) Microbiological Assay of Polyoxin D Zinc Salt Using 27-May- 43261815 Cylinder Cup/Agar Plant Method: Lab Project Number: KPD-93-007: KPQC- 1994

93-0001. Unpublished study prepared by Kaken Pharmaceutical Co., Ltd. 10 p.
17Polyoxin D Zinc Salt E PA-HQ-OPP-2014-0108

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### Blasberg, J. (1994) Physical and Chemical Properties of Polyoxin D Zinc Salt Technical Grade Active Ingredient (Color, Physical State, Odor, Melting Point, 27_May- 43261816 Density, Solubility, Dissociation Constant, pH, and Stability): Amended Final 1994

Report: Lab Project Number: 41032. Unpublished study prepared by ABC Lab., Inc. 128 p. Laster, W.; Williams, M. (1994) Physical and Chemical Properties of Polyoxin ^ 43261817 Z Wettable Powder (Physical State, Density, and pH): Final Report: Lab Project 27_May1994 Number: 41033. Unpublished study prepared by ABC Lab., Inc. 42 p.

~ 

### Muramatsu, J. (1994) Polyoxin Z Wettable Powder: Quality Control Data and 27-May- 43261818 Support for the Proposed pH Specifcation. Unpublished study prepared by 1994

Kaken Pharmaceutical Co., Ltd. 5 p. Nandihalli, U. (1994) Determination of Stability for Polyoxin D Zinc Salt 43261819 Technical Grade Active Ingredient: Final Report: Lab Project Number: 6293- 27_May1994

~ 

### 125. Unpublished study prepared by Hazleton Wisconsin, Inc. 42 p.

Nandihalli, U. (1994) Storage Stability and Corrosion Characteristics of 27-May- 43261820 Polyoxin Z Wettable Powder: Lab Project Number: HWI 6293-128. 1994

Unpublished study prepared by Hazleton Wisconsin, Inc. 26 p.

~ 

### Muramatus, J. (1994) Storage Stability of Polyoxin D Zinc Salt Technical 43261821 Grade Active Ingredient and Polyoxin Z Wettable Powder: Lab Project 27-MayNumber: KPD-93-021: KPQC-93-0003. Unpublished study prepared by Kaken 1994

r--- 

### Pharmaceutical Co., Ltd. 32 p.

Hori, M. (1994) Polyoxin D Zinc Salt Technical Grade Active Ingredient and 43261822 Polyoxin Z Wettable Powder: Summary of Acute Toxicology Results and 27-MaySupport for the Proposed Precautionary Labeling. Unpublished study prepared 1994 by Kaken Pharmaceutical Co., Ltd. 6 p. Shults, S.; Brock, A.; Laveglia, J. (1992) Acute Oral Toxicity Study in Rats 43261823 with Polyoxin D Zinc Salt Technical Grade Material: Lab Project Number: 27_May1994 3726-90-0351-TX-041. Unpublished study prepared by Ricerca, Inc. 35 p. Nakamura, T. (1993) Acute Oral Toxicity Study of Polyoxin Z Wettable 27-May- 43261824 Powder in Rats: Lab Project Number: 88-10. Unpublished study prepared by 1994

Kaken Pharmaceutical Co., Ltd. 19 p.

18Polyoxin D Zinc Salt EPA-H Q-OPP-2014-0108 www.regulations.gov
Maruyama, K. (1993) Acute Dermal Toxicity Study of Polyoxin D Zinc Salt in 

### 2 M y- I 43261825 Rats: Lab Project Number: 89-04. Unpublished study prepared by Kaken 1994

Pharmaceutical Co. Ltd. 23 p. ~

- ----- '
------ '
-- r ------- ~ 

### I'

-- Maruyama, K. (1993) Acute Dermal Toxicity Study of Polyoxin Z Wettable 127-May- ~ 43261826 Powder in Rats: Lab Project Number: 89-04(WP). Unpublished study prepared 1994

by Kaken Pharmaceutical Co. Ltd. 24 p. i i

-- -- -- 

### ~ Hardy, C.; Jackson, G. (1994) Polyoxin D Zinc Salt Acute Inhalation Toxicity 27-May_ 43261827 in Rats: 4-Hour Exposure: Lab Project Number: KKC 9/88325. Unpublished 1994 i

study prepared by Huntingdon Research Center Ltd. 51 p. Nachreiner, D. (1993) Polyoxin Z Wettable Powder: Acute Dust Inhalation ~ 27-May_ 43261828 Toxicity Study in Rats: Lab Project Number: 93N 1230. Unpublished study 1994 I

prepared by Bushy Run Research Center (BR.RC). 65 p. I Shults, S.; Brock, A.; Laveglia, J. (1992) Primary Eye Irritation Study in Albino ~ 43261829 Rabbits with Polyoxin D Zinc Salt Technical Grade Material: Lab Project 27-May- ;

Number: 3726-90-0353-TX-001. Unpublished study prepared by Ricerca, Inc. 1994 ~ 32 p. ~ Liggett, M.; Smith, P. (1994) Irritation Effects on the Rabbit Eye of Polyoxin Z —~ 27 May- 43261830 Wettable Powder "Kaken": Lab Project Number: 87674D/KKC 3/SE. I 1994

Unpublished study prepared by Huntingdon Research Center Ltd. 20 p.

~ Shults, S.; Brock, A.; Laveglia, J. (1992) Primary Dermal Irritation Study in 43261831 Albino Rabbits with Polyoxin D Zinc Salt Technical Grade Material: Lab 27-MayProject Number: 3726-90-0354-TX-001. Unpublished study prepared by 1994 Ricerca, Inc. 20 p. `
_- -__-_ _-_ - - ----------- ---------I_______- ~ Liggett, M.; Smith, P. (1994) Irritation Effects on Rabbit Skin of Polyoxin Z ~ 27-May_ 43261832 We tt able Powder "Kaken": Lab Project Number: 87628D/KKC 2/SE. 1994 i

Unpublished study prepared by Huntingdon Research Centre Ltd. 18 p. 

# ~

-- -- ------ --- ------ ------- -- -----__ Tanigaki, T. (1993) Skin Sensitization Study of Polyoxin D Zine Salt in the Guinea Pig: Lab Project Number: 88-08-13. Unpublished study prepared by 43261833 27-May- I 1994 ~ Kaken Pharmaceutical Co. Ltd. 24 p.

iMPolyoxin D Zinc Salt EPA-H Q-O P P-2014-0108

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r ---- ------- -

Nagatahira, R. (1991) Skin Sensitization Study of Polyoxin Z Wettable Powder 43261834 in Guinea Pigs: Lab Project Number: SKT20. Unpublished study prepared by 27-May1994 Kaken Pharmaceutical Co. Ltd. 33 p.

r----- --



### Yoshida, J.; Kubo, K. (1993) Studies on Chromosomal Aberration by Polyoxin 43261835 D Zinc Salt in CHL Cells: Lab Project Number: KEN 87-04-03. Unpublished 27-May1994 study prepared by Kaken Pharmaceutical Co. Ltd. 35 p.

r 

### i -----



### Shirasu, Y.; Moriya, M.; Kato, K. (1976) Mutagenicity Testing on Polyoxin D i Zinc Salt in Microbial Systems: (1) Rec-Assay with Bacillus subtilis H-17 and ; M-45 (2) Reverse Mutation Tests With and Without a Liver Metabolic 43261836 Activation Systems Using Two Strains of Escherichia coli and Four Strands of 27-MaySalmonella typhimurium, and (3) Host-Mediated Assay with S. typhimurium 1994 G-46 in Mice: Lab Project Number: 152-17-2. Unpublished study prepared by The Institute of Environmental Toxicology, Kaken Pharmaceutical Co., Ltd. 16

~ 

### P.

Yoshida, M. (1993) Teratology Study on Polyoxin D Zinc Salt (PSB) in 43261837 Rabbits: Lab Project Number: 258-B. Unpublished study prepared by The 27-May-

~- 

### Institute of Environmental Toxicology, Kaken Pharmaceutical Co., Ltd. 87 p. 1994

43261838 Hori, M. (1976) Summary of Chronic Toxicity Study of Polyoxin D Zinc Salt 27-May-

~ -- 

### in Mice: Unpublished study prepared by Nippon University Medical Dept. 13 p. 1994
43261839 Hori, M. (1976) Summary of Chronic Toxicity Study of Polyoxin D Zinc Salt 27-Mayin Rats: Unpublished study prepared by Nippon University Medical Dept. 14 p. 1994 Pedersen, C. (1992) Polyoxin D Zinc Salt Technical Grade Material: 21-Day 27-May- 43261840 Acute Oral LD50 Study in Mallard Ducks: Lab Project Number: 103-002-04. 1994

Unpublished study prepared by Bio-Life Ass., Ltd. 37 p.

r 

### Pedersen, C. (1992) Polyoxin D Zinc Salt Technical Grade Material: 8-Day 43261841 Acute Dietary LD50 Study in Mallard Ducklings: Lab Project Number: 103- 27-May1994

-- - 

### 001-02. Unpublished study prepared by Bio-Life Associates, Ltd. 37 p.

--- 

### Bowman, J.; Herzig, R. (1994) Polyoxin D Zinc Salt Technical Grade Active 27-May- 43261842 Ingredient: Acute LC50 to Rainbow Trout (Oncorhynchus mykiss): Lab Project 1994

Number: 41063. Unpublished study prepared by ABC Lab., Inc. 220 p.

~

20Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108

www. regulations.gov
Bowman, J.; Herzig, R. (1994) Polyoxin D Zinc Salt Technical Grade Active I27-May43261843 Ingredient: Acute EC50 to Daphnia magna: Lab Project Number: 41064. 1994

Unpublished study prepared by ABC Lab., Inc. 227 p. Tokumura, J. (1990) Effects of Polyoxin D on Two-Spotted Spider Mite, Brown Plant Hopper and Diamond Back Moth: Lab Project Number: 27-May- 43261844 POLYOXIN 154-11. Unpublished study prepared by Res. Div. of 1994

Agrochemicals & Animal Health Products, Kaken Pharmaceutical Co., Ltd. 10 ~

~ 

### p- I
43323000 Kaken Pharaceutical Co., Ltd. (1994) Submission of toxicity data in support ~ 02-Augm of the registration for Polyoxin D Zinc Salt. Transmittal of 1 study. 11994 Yoshida, J. (1994) Reverse Mutation Test of PSB with Bacteria: Lab Project ~ ~ 02-Aug43323001 Number: SMTO I. Unpublished study prepared by Safety Evaluation Labs., 11994

Kaken Pharmaceutical Co., Ltd. 31 p. f i 43372100 Kaken Pharmaceutical Co., Ltd. (1994) Submittal of Pesticide Use Data and

Residue Data in Support of Registration of STOPIT Wettable Turf Fungicide 16-Sep- ;1994 and Polyoxin D Zinc Salt Technical. Transmittal of 3 studies.
~ ~ 43372101 -- ----;-

-- -- -- – Endo, A.; Kakiki, K.; Misato, T. (1970) Mechanism of mode of action of 1 16-Sepantifungal agent Polyoxin D. Journal of Bacteriology 104(1):189-196. I 1994 Teraoka, T.; Vega, C.; Hosokawa, D. et al. (1987) Effect of Polyoxin D on cell ~16-Sep43372102 wall regeneration and biosynthesis in protoplasts from Pyricularia oryzae. 1994

— Journal of Pesticide Science 13:213-220.

--- ------ -- ----- 43372103 Ebata, E. (1982) Residue Analysis of Polyoxin B, D and Blasticidin S in Crops

and Soil. Unpublished paper presented at the Vth International Congress of 16-Sep1 Pesticide Chemistry; 1982, Kyoto, Japan. 11 p.

~ i

43823700 Kaken Pharmaceutical Co., Ltd. (1995) Submission of Product Chemistry Data

in Support of the Application for Registration for Polyoxin D Zinc Salt i
~I 23-Oct11995 Technical. Transmittal of 1 Study.

~ Nandihalli, U. (1995) Storage Stability of Polyoxin D Zinc Salt Technical

~ 23-Oct43823701 Grade Active Ingredient: Final Report: Lab Project Number: 6293-126: HWI 1995

6293-126. Unpublished study prepared by Hazleton Wisconsin, Inc. 47 p. 

### i

21Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108
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# ~ Kaken Pharmaceutical Co., Ltd. (1997) Submission of Product Chemistry Data 

# ~ - 44214600 in Suppo rt of the Applications for Registration of Polyoxin D Zinc Salt TGAI 

# 1 1997

Polyoxin Z Wettable Powder. Transmittal of 1 Study.

~ 

# ~ Hori, M. (1994) Polyoxin D Zinc Salt Technical and Polyoxin Z Wettable 

# ~ 1997 

# I 07-Feb- 44214601 Powder: Product Identity, Manufacturing Process, Unintentional Ingredients,



# ~ and Certified Limits: (Amended). Unpublished study prepared by Kaken 1997 

# 1 Pharmaceutical Co., Ltd. 74 p. Kaken Pharmaceutical Co., Ltd. (1997) Submission of Product Chemistry Data 44249700 12-Mar-

~ -- 

### in Support of the Registration of Polyoxin D Zinc Salt. Transmittal of 1 Study.

------ --- 

### 1997 Hashimura, M. (1997) Analysis of Inorganic Salts in Polyoxin D Zinc Salt 44249701 Technical Grade Active Ingredient: Lab Project Number: KPQC-96-001. 12-MarUnpublished study prepared by Kaken Pharmaceutical Co., Ltd. 25 p. 1997

44249800 Kaken Pharmaceutical Co., Ltd. (1997) Submission of Product Chemistry Data 12-Marin Support of the Registration for Polyoxin D Zinc Salt. Transmittal of 1 Study. 1997 Hashimura, M. (1997) Contamination Test and Quality Control Examinations 44249801 and Method in Fermentation of Polyoxin D: Lab Project Number: 12-MarHASHIMURA-21897. Unpublished study prepared by Kaken Pharmaceutical 1997

i 

### Co., Ltd. 20 p. Arysta LifeScience North America Corporation and Kaken Pharmaceautical 47120900 Co. Ltd. (2007) Submission of Toxicity Data in Support of the Amended 01-MayRegistrations of Polyoxin D Zinc Salt Technical and Endorse Water Dispersible 2007 Granules. Transmittal of 2 Studies. Padgett, E. (2006) A Splenic Antibody Following Dietary Exposure to Polyoxin 47120901 D Zinc Salt Technical in Female Mice for 28 Days. Project Number: 0 1 -MayWIL/476003, 1990/A/1, ITI/906. Unpublished study prepared by WIL Research 2007 Laboratories, Inc. 490 p.

--- r - --- ----



### Saito, S.; Tokunaga, Y.; Kawade, K. (1975) Effects of Polyoxin D Salt on 47120904 Succeeding Generations of Rats. Unpublished study prepared by Nihon 01-MayUniversity. 22 p. 2007

22Polyoxin D Zinc Salt EPA-HQ-OPP-2014-0108 www.regul ions.gov


### Arysta LifeScience North America Corporation (2007) Submission of Toxici 05-Jun- i 

## ~ 47145100 Data in Support of the Registrations of Polyoxin D Zinc Salt Technical and 2007

- 

### Endorse Water Dispersible Granules. Transmittal of 2 Studies.

-- 

## ~

-- - 

### Takahashi, N. (2006) Polyoxin D Zinc Salt Technical: Repeated Dose 90-Da 47145101 Oral Toxicity Study in Rats (A Translated version of the Original Report). 05-Jun- 2007 

## ~ Project Number: IET/03/0111. Unpublished study prepared by Institute of j Environmental Toxicology. 374 p.

Matsumoto, K. (2003) Micronucleus Test of Polyoxin D Zinc Salt Technical 05-Jun- 

## ~ 47145102 Mice. Project Number: IET/03/0039. Unpublished study prepared by Institut 2007

_ 

### of Environmental Toxicology. 24 p. I



### Kaken Pharmaceutical Co., Ltd. (2011) Submission of Product Chemistry, Environmental Fate, Residue, Fate and Efficacy Data in Support of the 09-Nov- 48653300 Amended Registration of Polyoxin D Zinc Salt Technical and the Petition for 2011

Tolerance of Polyoxin D Zinc Salt for Use on All Agricultural Commodities. Transmittal of 15 Studies.

~ 

### Smith, C. (2011) Polyoxin D Zinc Salt: Product Chemistry Summary for a 09-Nov- 

## ~ 1 48653301 Tolerance Exemption Petition. Unpublished study prepared by Kaken 2011

Pharmaceutical Co., Ltd. 12p. 

## ~ — Sinning, D. (2011) Polyoxin D Zinc Salt TGAI: UV/Visible Absorption: Fin T09-Nov48653302 Report. Project Number: 4990/04. Unpublished study prepared by Case 2011

Consulting Laboratories, Inc. 14p. Smith, C. (2011) Polyoxin D Zinc Salt: Environmental Fate Summary for a 09-Nov48653303 Tolerance Exemption Petition. Unpublished study prepared by Kaken 2011

Pharmaceutical Co., Ltd. 17p. Herczog, K.; DiFrancesco, D. (2009) A Hydrolysis Study of [(Ca.rbon 

## ~ 09- Nov 48653304 14)]Polyoxin D in pH 4.0, pH 5.0, pH 7.0 and pH 9.0 Buffer. Project Numbe 2011

017868/1. Unpublished study prepared by Ricerca Biosciences, LLC. 169p. 1 

### Miner, P. (2009) Photodegradation of [(Carbon 14)] Polyoxin D in Sterilized 09-Nov48653305 Natural Water and Sterilized Buffer by Simulated Sunlight. Project Number: 2011

017869/1. Unpublished study prepared by Ricerca Biosciences, LLC. 263p.

23Polyoxin D Zinc ~ alt EPA-HQ-OPP-2014-0108 www.regulations.gov


### DiFrancesco, D.; Grommes, S. (2009) Metabolic Fate of [(Carbon 14}] 48653306 Polyoxin D in Aerobic Soil. Project Number: 017866/1. Unpublished study 09-Nov2011 prepared by Ricerca Biosciences, LLC. 139p. 

# 1

Smith, C. (2011) Polyoxin D Zine Salt: Residue Chemistry Summary. 09-Nov- 48653307 UApublished study prepared by Kaken Pharmaceutical Co., Ltd. 64p. 2011

Anonymous (2005) Minimum Inhibitory Concentration (MIC) of Polyoxin D 09-Nov- i 48653308 against Various Bacteria. Project Number: KPD05/043. Unpublished study 2011

prepared by Kaken Pharmaceutical Co., Ltd. 6p. H yashi, O. (2007) Metabolic Fate of [(Carbon 14)] Polyoxin D in Grape 09-Nov- 48653309 (Translated Version of the Original Report). Project Number: IET/06/8001. .2011

Unpublished study prepared by Institute of Environmental Toxicology. 165p. !



# I

_ Findak, D.; Herczog, K. (2008) Metabolism of [(Carbon 14)] Polyoxin D in 09-Nov- 48653310 Tomato Plants. Project Number: 017870/1. Unpublished study prepared by 2011

Ricerca Biosciences, LLC. 157p.

r 

### Hashi, O. (2010) Metabolic Fate of [(Carbon 14)] Polyoxin D in Lettuce ~ 

### 48653311 Pl , t(Translated Version of the Original Repo 

### rt ). Project Number: 09-NovIE /07/8018. Unpublished study prepared by Institute of Environmental 2011 T icology.137p. I S'th, C. (2011) Polyoxin D Zinc Salt: Toxicology Summary for a Tolerance 09-Nov- 48653312 E•emption Petition. Unpublished study prepared by Kaken Pharmaceutical Co., 2011

Ltd. 9p. W. da, K. (2011) Polyoxin D Zinc Salt: Bacterial Reverse Mutation Test 09-Nov- 48653313 ( anslated Version of the Original Report). Project Number: IET/10/0030. 2011

Ut published study prepared by Institute of Environmental Toxicology. 36p. W da, K. (2011) Polyoxin D Zinc Salt: Chromosome Aberration Test in 48653314 C tured Mammalian Cells (Translated Version of the Original Report). Project 09-NovN ber: IET/10/0031. Unpublished study prepared by Institute of 2011

— 

### E ironmental Toxicology. 27p. ~ 

### I Fq ii, S. (2411) Teratogenicity Study of Polyoxin D Zinc Salt in Rats 09-Nov- 48653315 (T anslated Version of the Original Report). Project Number: SR09296. 2011

U ublished study prepared by Institute of Environmental Toxicology. 119p.
24Polyoxin D Zinc Salt EPA-H O-OPP-2414-0108

www

r Kaken Pharmaceutical Co., Ltd. (2011) Submission of Fate, Environmental 17-Nov48660400 Fate and Toxicity Data in Support of the Amended Registration of Polyoxin 2011

Zinc Salt Technical. Transmittal of 4 Studies. Smith, C. (2011) Polyoxin D Zinc Salt: Adsorption/Desorption, Soil Column 48660401 Leaching, Volatilization from Soil, Aerobic Soil Metabolism and Anaerobic 17-NovSoil Metabolism. Unpublished study prepared by Kaken Pharmaceutical Co., 2011 Ltd. l Op. 48660402 Smith, C. (2011) Polyoxin D Zinc Salt: Nontarget Plant Testing. Unpublished 17-Novstudy prepared by Kaken Pharmaceutical Co., Ltd. 6p. 2011Oishi, N. (2002) Growth Inhibition Study of Polyoxin D Zinc Salt Technical - i17-NovI 48660403 Algae. Project Number: 6123/066/044. Unpublished study prepared by 2011 ~

Biosafety Research Center. 50p. ~ Mori, K. (2001) Acute Oral Toxicity Study in the Honeybee with Polyoxin D j48660404 Zinc Salt Technical Grade Material. Unpublished study prepared by Japan Pla rit 17-NovProtection Assoc. Research Institute. 15p. 2011 j Kaken Pharmaceutical Company, Ltd. (2013) Submission of Product Chemis y 10-May- ; ~ 49125500 Data in Support of the FIFRA 6(a)(2) Data Requirements for Polyoxin D Zin 2013 I ~ Salt. Transmittal of 1 Study. i i 49125501 Smith, C.; Yano, T. (2013) Polyoxin D Zinc Salt Technical: Analysis of 10-MayImpurities. Unpublished study prepared by Kaken Pharmaceutical Co. 8p. 2013 ~

~ Kaken Pharmaceutical Company, Ltd. (2013) Submission of Product Chemis y ' 49220300 Data in Support of the FIFRA 6(a)(2) Data Requirements for Polyoxin D Zin 20-Sep- i
i I Salt Technical. Transmittal of 1 Study. 2013 i

Yano, T.; Takei, K; Smith, C. (2013) Polyoxin D Zinc Salt Technical: Analys s20-Sepi 49220301 of Impurities (Update). Unpublished study prepared by Japan Food Research 2013 ( Laboratories. 4p. I

--- -- -- -- -- -- - ---- --- - ---- ---- --~--- Kaken Pharmaceutical Company, Ltd. (2013) Submission of Product Chemis y ,2 1 -Oct49227700 Data in Support of the Amended Registration of Polyoxin D Zinc Salt ; 2013

Technical. Transmittal of 3 Studies. ~

-- _ — --~------------

25Polyoxin D EPA-H Q-O PP-2014-0108 www.regulations.gov
F tamata, K.; Takei, K. (2013) Polyoxin D Zinc Salt Technical: Description of 

### 2 

### 1 -Oct- 49227701 S 

### rt ing Materials and Production Process, and Discussion of Formation of 2013

I purities. Unpublished study prepared by Kaken Pharmaceutical Co, Ltd. 88p. no, T. Takei, K. (2013) Polyoxin D Zinc Salt Technical: 2-Batch Analysis 49227702 ar d Certified Limits. ProjectNumber: 13071066001/02, 13071066001/05, 21-Oct1 071066001/07. Unpublished study prepared by Japan Food Research 2013 L boratories and Kaken Pharmaceutical Co, Ltd. 168p. ,

49227703 io, T.; Takei, K. (2013) Polyoxin D Zinc Salt Technical: Analytical Methods

the Quantification of Polyoxin D Zinc Salt and Selected Impurities. Project 21-Octnber: R/ 11 /04/04/E, R/ 12/04/02/E, R/ 12/04/04/E. Unpublished study 2013 pared by Kaken Pharmaceutical Co LTD. 164p. KLi , en Pharmaceutical Company, Ltd. (2013) Submission of Product Chemistry 08-Nov49252900 Dta in Suppo 

### rt of the FIFRA 6(a)(2) Data Requirements for Polyoxin D Zinc 2013

S lt Technical. Transmittal of I Study. Yhno, T.; Takei, K. (2013) Polyoxin D Zinc Salt Technical: 7-Batch Analysis 49252901 (I 2013

terim Repo 

### rt ). Unpublished study prepared by Kaken Pharmaceutical Co, 08-NovL .9p.

~ J

DD 

### aken Pharmaceutical Company, Ltd. (2013) Submission of Product Chemistry 20-Dec49277300 in Suppo 

### rt of the FIFRA 6(a)(2) Data Requirements for Polyoxin D Zinc2013

t Technical. Transmittal of 1 Study. Y no, T.; Takei, K. (2013) Polyoxin D Zinc Salt Technical: Preliminary 20-Dec- 49277301 alysis and Ce 

### rt ified Limits (Final Repo 

### rt ). Unpublished study prepared by 2013

K ken Pharmaceutical Co, Ltd. 173p.

26