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Page 2 of 51 Fenpropimorph Registration Review Team

Human Health & Environmental Effects David Bays James Breithaupt Patricia Jennings Nathan Mottl Michelle Centra

Risk Management Donna Kamarei Rose Kyprianou Lorena Rivas

Office of General Counsel Philip RossDocket Number EPA

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Page 3 of 51 TERMS, ABBREVIATIONS AND SYMBOLS

A.I. or a.i. active ingredient
atm

- m 3 /mole a tmospheric pressure

- cubic meter per mole °C d egrees Celsius CAS Chemical Abstracts Service CFR Code of Federal Regulations DCI data call

- in EC 50 m edian (or 50 percent) e ffect c oncentration ECOTOX ECOTOXicology EDSP E ndocrine Disruptor Screening Program EPA Environmental Protection Agency FFDCA Feder al Food, Drug, and Cosmetic Act FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FQPA Food Quality Protection Act FWP Final Work Plan GLN guideline number IDS Incident Data System Koc o rganic carbon normalized soil

- water partition coefficient Kd s oil

- water partition coefficient Kow o ctanol

- water partition coefficient LC 50 m edian (or 50 percent) l ethal c oncentration LD 50 m edian (or 50 percent) l ethal d ose LOAEL lowest

- observed

- adverse

- e ffect

- l evel Log K ow l ogarithm of the octanol

- water partition coefficient
μg m icrogram mg/kg m illigram p er k ilogram mg/kg/day m illigram p er k ilogram p er d ay mg/L m illigram p er l iter mm Hg m illimeter of mercury MOE m argin of e xposure MRID Master Record Identification Number MRL m aximum r esidue l imit N/A n ot a pplicable

nm n anometers NOAEC no

- observed

- adverse

- effect

- c oncentration NOAEL n o

- o bserved

- a dverse

- e ffect

- l evel OCSPP Office of Chemical Safety and Pollution Prevention OECD Organization for Economic Co

- operation and Development OPP Offi ce of Pesticide Programs PAD p opulation a djusted d ose % p ercent PC Code Pesticide Chemical Code PCF p ounds p er c ubic foot pH power of h ydrogen or power of the con centration of the hydrogen ion pKa p ower of the acid dissociation constant or negative base

- 10 logarithm of the acid

dissociation constant of a solution
ppm p arts p er m illion PWP Preliminary Work Plan QSAR q uantitative s tructure

- a ctivity r elationship RED Rere gistration Eligibility DecisionDocket Number EPA

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Page 4 of 51 SAR s tructure a ctivity r elationship SF s afety f

actor TEP t ypical e nd

- u se p roduct TGAI t echnical grade active i ngredient TMDL total maximum daily l oads UF uncertainty factor UV/VIS ultraviolet/v isible light a bsorption WWTPs w astewater treatment plantsDocket Number EPA

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Page 5 of 51 

### Table of Contents
1 Introduction

................................ ................................ ................................ ............................. 7 1.1 Statutory and Regulatory Authority

................................ ................................ ................. 7 1.2 Updates to the Work plan

................................ ................................ ................................ . 7 1.3 Case Overview

................................ ................................ ................................ ................. 8 1.4 Chemical Identification and Properties

................................ ................................ ............ 9 1.5 Use/Usage Description

................................ ................................ ................................ ... 11 1.5.1 Registrations

................................ ................................ ................................ ........... 11 1.5.2 Summary of Registered Uses

................................ ................................ .................. 11 1.6 Regulatory History

................................ ................................ ................................ ......... 11 1.6.1 Tolerance Information

................................ ................................ ............................ 12 1.7 Incidents

................................ ................................ ................................ ......................... 12 1.7.1 Human Health

................................ ................................ ................................ ......... 12 1.7.2 Ecological

................................ ................................ ................................ ............... 12 2 Anticipated Data Needs

................................ ................................ ................................ ........ 12 3 Human Health Risk Assessment

................................ ................................ ........................... 14 3.1 Existing Toxicological Endpoints

................................ ................................ .................. 14 3.2 Dietary Exposure

................................ ................................ ................................ ............ 16 3.2.1 Food

................................ ................................ ................................ ........................ 16 3.2.2 Drinking Water

................................ ................................ ................................ ....... 16 3.3 Occupational and Residential Exposures

................................ ................................ ....... 16 3.3.1 Occupational Handler Exposure

................................ ................................ ............. 17 3.3.2 Residential Handler Exposures

................................ ................................ ............... 17 3.3.3 Residential Post

- Application Exposures

................................ ................................ . 17 3.4 Aggregate and Cumulative Exposure

................................ ................................ ............. 18 3.4.1 Aggregate Exposures

................................ ................................ .............................. 18 4 Environmental Risk Assessment

................................ ................................ ........................... 18 4.1 Environmental Fate Assessment

................................ ................................ .................... 20 4.1.1 Leaching from Wood

................................ ................................ .............................. 20 4.1.2 Water, Sediment, and Soil

................................ ................................ ...................... 20 4.1.3 Waste Water Treatment Plants (WWTPs)

................................ .............................. 21 4.1.4 Water Quality

................................ ................................ ................................ .......... 21 4.2 En vironmental Exposure Pathways

................................ ................................ ................ 21 4.3 Ecological Effects Assessment

................................ ................................ ....................... 22 4.3.1 Mechanism of Action

................................ ................................ .............................. 22 4.3.2 Measures of Effect (Ecotoxicology Endpoints)

................................ ...................... 22 4.4 Exposure Analysis Plan

................................ ................................ ................................ .. 23 4.4.1 Aquatic and Terrestrial Wildlife Exposure Estimates

................................ ............ 23 4.4.2 Screening Level Down

- the

- Drain Analysis

................................ ............................ 24 4.5 Effects Analysis Plan

................................ ................................ ................................ ..... 24 5 Endocrine Disruptor Screening Program (EDSP)

................................ ................................ . 24 6 Optional Label Changes

................................ ................................ ................................ ........ 25 7 Next Steps

................................ ................................ ................................ ............................. 25 8 References

................................ ................................ ................................ ............................. 26

Appendix A T oxicology Profile

................................ ................................ ............................... 27Docket Number EPA

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Page 6 of 51 Appendix B Environmental Fate

................................ ................................ ............................. 34 Appendix C Ecotoxicology Profile

................................ ................................ .......................... 40 Appendix D Screening Level Down

- the

- Drain Analysis

................................ ........................ 46 Appendix E Product Chemistry

................................ ................................ ............................... 47 Appendix F Comments Received Concerning the Preliminary Work Plan

............................ 50

List of Tables Table 1

– Summary of Anticipated Risk Assessments and Data Needs for the Registration Review of Fenpropimorph....................................................................................8 Table 2

– Anticipated Registration Review Schedule

................................ ................................ .... 9 Table 3

– Chemical Identification of Fenpropimorph

................................ ................................ .... 9 Table 4

– Physical

- Chemical and Environmental Fate Properties for Fenpropimorph

................ 10 Table 5

– Summary of Fenpropimorph Registered Uses

................................ .............................. 11 Table 6

– Studies An ticipated as Needed for the Registration Review of Fenpropimorph

.......... 13 Table 7

– Existing Toxicological Endpoints

................................ ................................ ................. 15 Table 8

– Occupational Handler Exposure Scenarios for Fenpropimorph

................................ ... 17 Table 9

– Aquatic Toxicity Values for Parent Fenpropimorph and Fenpropimorph Acid

........... 19 Table 10

– Ecological Effects Endpoints Selected for Assessing Risks from Fenpropimorph Use

................................ ................................ ................................ ................................ ....................... 22Docket Number EPA

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## 1 Introduction

This document is the United States Environmental Protection Agency ’s ( USEPA, EPA or “the
agency ”) Final Work Plan ( F WP) for fenpropimorph . The FWP document explains what EPA's Office of Pesticide Programs (OPP) knows about fenpropimorph , highlighting anticipated data and assessment needs, identifying the types of information that would be especially useful to the
agency in conducting the review, and providing an anticipated timeline for completing fenpropimorph ’s review.

The registration review process was designed to include a public participation component to solicit input from interested stakeholders. The agency intends, by sharing this informatio n in the docket, to inform the public of what it knows about fenpropimorph and what types of new data or other information would be helpful for the agency to receive as it moves toward a decision on fenpropimorph

. 

## 1.1 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 generally must be registered by the USEPA based on scientific data showing that they will not cause unreasonable risks to human health or the environment when used as directed on product labeling. The registration review program is intended to make sure that, as the ability to assess risk evolves and as policies and practices change, all registered pesticides continu e 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 the registration review program, the agency periodically re evaluates pesticides to make sure that as change occurs, products in the marketplace can be used safely. Information on this program is provided at http://www2.epa.gov/pesticide

- reevaluation

.
The a gency is implementing the registration review program pursuant to Section 3(g) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and will review each registered pesticide every 15 years to determine whether it continues to meet the FIFRA s tandard for registration. The regulations governing registration review begin at 40 CF R 155.40. The agency will consider benefits information and data as required by FIFRA. The public phase of registration review begins when the initial docket is opened fo r each case. The docket is the
agency ’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

. 

## 1.2 Updates to the Work plan
Since the publication of the PWP, the agency has made the following updates:

 Correcte d the timeline in Table 2, the “ Anticipated Registration Review T able

. ”

 Deleted “ Guidance for Commenters” section.

 Updated Table 1, the “Summary of Anticipated Risk Asse ssments and Data Needs for the Registration Review of Fenpropimorph.” Edited a study title , and removed the honey beeDocket Number EPA

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Page 8 of 51 acute contact study from Table 6 “Studies Anticipated as Needed for the Registration Review of Fenpropimorph.”

 Updated Section 7
, “ Next Steps

. ”

 Added Appendix F , which includes the a gency’s response to comments submitted about the PWP.

 Corrected formatting and typographical errors

.

The a gency received two submissions during the public comment period on the initial docket. See Appendix F for the agency’s responses to these comments.

Comments received did result in a modification to the anticipated data needs in the fenpropimorph PWP . This document makes final the work plan for the fenpropimorph registration review process.



## 1.3 Case Overview
The Preliminary Work Plan (PWP) for fenpropimorph was published on September 2 4, 2014

, and the 60

- day comment period ended on November 24, 2014. The agency received two submissions during the public comment period on the initial docket. Documents associate d with this registration review can be viewed at http://www.regulations.gov in docket EPA

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. Tables 1 and 2 b elow summarize the issues relevant to this registration review case and the anticipated registration review schedule

.

Table 1

– Summary of Anticipated Risk Assessments and Data Needs for the Registration Review of Fenpropimorph

Risk Assessment Assessment Necessary to Support Registration Review Date of Most

Recent Assessment Type of Assessment

Required (New/Updated) Data Anticipated as Needed (See Table 6 for detail s)

Dietary (food) No 10

- 19

- 2005 None None Dietary (drinking water) No N/A None None

Occupational Handler Yes 8

- 2

- 07 Updated 875.1700 Product Use Information 870.7800 Immunotoxicity

Residential Handler No N/A None None

Residental Post Application

- Incidental Oral and Dermal No N/A None None

Residental Post Application

- Inhalation No N/A None None

Aggregate No N/A None None

Cumulative No N/A None None

Tolerance Review No 10

- 19

- 20 05 None NoneDocket Number EPA

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Page 9 of 51 Risk Assessment Assessment Necessary to Support Registration Review Date of Most

Recent Assessment Type of Assessment

Required (New/Updated) Data Anticipated as Needed (See Table 6 for detail s)

Ecological Yes 7

- 12

- 2007 (original) 1 2

- 10

- 2009 (updated) Updated None

N/A = Not applicable

Table 2

– Anticipated Registration Review Schedule

Anticipated Activity Target Date * Completion Date Phase 1: Opening the Docket Open Docket and 60

- Day Comment Period for Preli minary Work Plan 2014

- 0 9 2014

- 0 9

- 24
Close Public Comment Period 2014

- 11 2014

- 11

- 24 Phase 2: Case Development
Issue Final Work Plan 2015

- 03 2015

- 03
Issue Data Call

- In (DCI) 2016

- 03
Receive Data to be Considered in Risk Assessment 201 7

- 03 Open 30

- Day Public Comment Period for Preliminary Risk Assessment(s) 201 8

- 09
Close Public Comment Period 201 8

- 10 Phase 3: Registration Review Decision and Implementation Open 60

- Day Public Comment Period for Pro posed Decision 20 19

- 03
Close Public Comment Period 20 19

- 05
Issue Final Decision 20 19

- 09 Begin Post

- Decision Follow

- up 20 19 Total (years) 5

* The anticipated schedule will be revised as necessary ( e.g ., need arising under the Endocrine Disruptor Screening Program with respect to the active ingredient in this case).


## 1.4 Chemical Identification and Properties

Table 3 presents the active ingredient to be assessed in case 5112 : parent fenpropimorph (PC Code 121402 ) and the degradate fenpropimorph acid (PC Code 621402, 621602)

. Product chemistry data for fe npropimorph acid were not submitted to the agency, and as a result, the agency accessed other sources of information.

Table 3

– Chemical Identification of Fenpropimorph

Chemical Name Fenpropimorph Fenpropimorph acid (degradate) 2

, 3

Chemical Classification Morpholine Morpholine

1 Petrie et al., July 12, 2007 and Petrie, Rick, February 10, 2009

2 Chemical Book, http://www.chemicalbook.com/ChemicalProductProperty_EN_CB72545117.htm
3 Pesticide Action Network, http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC41987Docket Number EPA

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Page 10 of 51 PC Code 121402 621402, 621602
CAS N umber 67564

- 91

- 4 121098

- 45

- 1 Molecular Formula C 20 H 33 NO C 20 H 31 NO 3
Molecular Weight (grams/mole) 303.48 333.47

Smiles code CC1CN(CC(O1)C)CC(C)Cc2ccc(cc2)C( C)(C)C CC1CN(CC(O1)C)CC(C)Cc2ccc(cc2)C(C)(C)C (=O)(O)

Molecular Structure

The f enpropimorph product chemistry information relevant to risk assessment is summarized in Table 4 , and the details of the product chemistry ( Source: MRIDS 44323904, 44323906, 44835201

, 45857201, 45857202, 45857203, 45857219, 4609750 1, and 46097502 ) are discussed in Appendix E

.

Table 4

– Physical

- Chemical and Environmental Fate Properties fo r Fenpropimorph

Guideline No. Parameter Fenpropimorph Fenpropimorph Acid (degradate) 4

Physical/Chemical Properties

830.7000 pH 8.6 at 1% in CIPAC water 8.2 at 1% in de

- ionized water Not available

830.7050 UV/Visible

Absorption Photolytically stable in artificial sunlight

(≥290 nm) for up to 30 days at pH 5 and 25 o C. Expected to be p hotolytically stable in artificial sunlight (≥290 nm) based on chemical structure

830.7200 Melting point

( o C) Liquid at STP 308.11

830.7220 Boiling point

( o C) > 300 o C 507.95

830.7300 Density 0.933 g/cm 3 Not available

830.7370 Dissociation

constant pK a : 6.98 (20oC);

pK b 7.02 @ 20oC and 7.19 at 25oC Not available

830.7550 Octanol

- water

partition coefficient at 25 o C (Log K ow ) 2.6 (22 o C, pH 5)

4.1 (22 oC, pH 7) 4.4 (22 oC, pH 9) 0.7

830.7840 Solubility in

water (mg/L) pH 7: 4.32 mg/L at 20oC;

pH 9

- 11: 3.53 mg/L at 20oC 16.7

830.7950 Vapor pressure

(mmHg) 3.5 x 10

- 5 at 20oC;

6.5 x 10

- 5 at 25 oC 1.16 x 10

- 11

4 EPI

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Page 11 of 51 Guideline No. Parameter Fenpropimorph Fenpropimorph Acid (degradate) 4

None (calculated) Henry’s Law

(atm m 3 mol

- 1 ) (assumes pH 7 and 25 o C) 6 x 10

- 6 3.05 x 10

- 13

atm

- m 3 /mol = atmosphere cubic meter per mole; o C = degrees Celsius; mg/L = milligrams per liter; mmHg = millimeters of mercury;



## 1.5 Use/Usage Description

1.5.1 Registrations There are two EPA registered products containing fenpropimorph as an active ingredient (a.i.) which are limited to antisapstain use on freshly cut wood products during storage and transit only

. One product is registered as a manufacturing use product (MUP , 96 % a.i. ) and the other product is registered as an end

- use product (EUP , 5.4 % a.i. ). Both products are liquid formulations (emulsifiable concentrates).



### 1.5.2 Summary of Registered Uses

Tabl e 5 presents a summary of the registered uses of fenpropimorph that will be assessed in this registration review

. F enpropimorph can be applied by the following application methods: non

pressure wood treatment through dip or spray to control sapstain, prevent m old and decay on green or freshly cut lumber and wood products like logs, poles, posts, composites, veneers and wood chips and saw dust

.
The sole active end

- use label states that treated lumber must be stored under cover, indoors, or at least 100 feet f

rom any pond, lake, stream, wetland, or river to prevent possible runoff of the product into the waterway. As per the labels, t reated lumber stored within 100 feet of a pond, lake

, stream, wetland, or river must be either covered with plastic or surrounded by a berm to prevent surface water runoff into the nearby waterway. The label also notes that “the product is intended to provide sapstain, mold and decay control during storage and transit which is not intended to extend to the end

- use site.” The product is not intended to be efficacious in the end

use site.

Table 5

– Summary of Fenpropimorph Registered Uses

Use Application Method Application Rate (ppm)

Wood Treatment

Non

- pressure treatment ( Antisapstain ) Dip Tank 18.9 ppm Spray System 54 ppm



## 1.6 Regulatory Histor y The first pesticide product containing f enpropimorph was registered on September 29, 1998 for the use of wood treatment

. A Reregistration Eligibility Decision (RED) was not completed forDocket Number EPA

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Page 12 of 51 fenpropimorph because the first pesticide product containing it was registered after November 1, 1984.



### 1.6.1 Tolerance Information

Fenpropimorph has a tolerance in 40 CFR 180.616 for imported bananas at a rate not to exceed a limit of 2.0 ppm. Import tolerance s will not be assessed as part of registration review of fenpropimorph.



## 1.7 Incidents

1.7.1 Human Health

No fenpropimorph human poisoning incidents have been reported in OPP’s Incident Data System (IDS) for the time period from 2005 to 2012 , based on a search conducted on July 17, 2014.



### 1.7.2 Ecological No fenpropimorph ecological incidents have been reported in OPP’s IDS for the time period from 2005 to present , b ased on a search conducted on July 17, 2014.


## 2 A nticipated Data Needs

Table 6 presents a summary of the data anticipated as being needed to support this registration review.Docket Number EPA

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Page 13 of 51 Table 6

– Studies Anticipated as Needed for the Registration Review of Fenpropimorph

GLN Study Name Test Substance Time Frame (Measured in months from DCI Receipt) Risk Assessment(s) Data Will Support Use Site(s) Triggering Anticipated Data Requirement Applicable

Exposure Scenario

Studies Anticipated to be Required through the Registration Review DCI

870.7800 Immunotoxicity TGAI 12 months Occupational Assessment Antisapstain Worker exposure

875.1700 Product Use Information TEP 12 months Occupational handler Antisapstain Worker exposureDocket Number EPA

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Page 14 of 51 

## 3 Human Health Risk Assessment

The existing toxicology data base for fenpropimorph is considered substantial and of high scientific quality

. Toxic ological endpoints have been selected from this database to conduct risk assessment(s) for initial pesticide registration as well as maintaining registration of products incorporating fenpropimorph as an active ingredient. However, there remains one data gap; an immunotoxicity study (OCSPP 870.7800) conducte d with the TGAI fenpropimorph. This special test is an anticipated data require ment for all antimicrobial non

- food, pesticide products (Federal Register, Vol. 78, No. 89, May 8, 2013/Rules and Regulations).

The agency anticipate s the need to revise the human health risk assessment for fenpropimorph

, specifically, the original occupational assessment that was recently conducted for registration in 2007

. The agency expect s to require additional data (see Table 6) for use in conducting the registration review.

For this registration review case, t here are no intended food/food con tact uses for registered products containing fenpropimorph when used as an antimicrobial agent for the control of sapstain, mold and decay of freshly cut lumber and wood products during storage and transit only. Although there is an established import tole rance for fenpropimorph on bananas, the import tolerance will not be reassessed during registration review (see Section 1. 6 .1).



## 3.1 Existing Toxicological Endpoints

In the most recent antimicrobial risk assessment for fenpropimorph ( D342435 ), the a gency selected doses and endpoints , and established uncertainty factors and Margin of Exposure s ( MOEs ) from the existing toxicology data base to conduct human health risk assessments (Table 7) . Short

- and intermediate

- term incidental oral exposure doses/e ndpoints as well as short

- and intermediate

- term dermal and inhalation exposure doses/endpoints were used for risk assessment
purposes. In addition, t he target MOE of 100 was used for all dermal exposure scenarios assessed. A target MOE of 100 was also u sed for the inhalation exposure scenarios with an additional 10x uncertainty factor (total uncertainty factor of 1000) applied to the NOAEL to account for the lack of a route

- specific inhalation toxicity study (i.e. inhalation endpoint established from an oral toxicity study requiring route

- to

- route extrapolation) to determine if a
route

- specific inhalation toxicity study is warranted.

However, the a gency anticipates requiring an immunotoxicity study and will revisit the endpoints to determine if any revisions are necessary.Docket Number EPA

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Page 15 of 51 Table 7

– Existing Toxicological Endpoints

Exposure Scenario Dose Used in Risk

Assessment (mg/kg/day) Target Margin of Exposure

(MOE), Uncertainty Factor

(UF), FQPA Safety Factor (SF) Study and Toxicological Effects

Incidental Oral Residential

Short

- Term (1

- 30 days) and Intermediate

- Term (1

- 6 months) NOAEL(dev

. ) =

1 5 mg/kg/day UF = 100 (10x inter

- species extrapolation, 10x intra

- species variation) Target MOE res. = 100 Prenatal Developmental Toxicity in Rabbits (MRID 44323914 )

LOAEL (dev

. ) = 30 mg/kg/day based on cleft palate, 4/116 fetuses (2/20 litters), 0 in control; anomalies

Dermal Irritation Occupational, Residential

Short

- Term (1

- 30 days) A d ermal i rritation risk assessment is not needed because occupational use s are mitigated via PPE and

no residential dermal exposure is expected

.

Dermal a Occupational, Residential

Short

- Term (1

- 6 months) NOAEL ( mat.) =

10 mg/kg/day UF = 100 (10x inter

- species extrapolation, 10x intra

- species variation) Target MOE occ./res. = 100 Prenatal Developmental Toxicity in Rats (MRID 44323912)

LOAEL (mat.) = 40 mg/kg/day based on decreased body weight gain

Dermal a Occupational, Residential

Intermediate

- Term (1

- 6 months) NOAEL =

0.7 mg/kg/day (males) 0.8 mg/kg/day (females) UF = 100 (10x inter

- species extrapolation, 10x intra

- species variation) Target MOE occ./res. = 100 90

- Day Oral Toxicity and Neurotoxicity in Rats (MRID 44380105)

LOAEL (sys.) = 7.1 mg/kg/day (m

. )

8.5 mg/kg/day (f.) based on decreased body weight and body weight gain in both sexes Inhalation b Occupational, Residential

Short

- Term (1

- 30 days) NOAEL (mat.) =

10 mg/ kg/day UF = 100

( 10 x inter

- species extrapolation, 10x intra

- species variation) Target MOE occ./res. = 100 Prenatal Developmental Toxicity in Rats (MRID 44323912 )

LOAEL ( mat. ) = 40 mg/kg/day based on decreased body weight gain

Inhalation b Occupational, Residential

Intermediate

- Term (1

- 6 months) NOAEL =

1.7 mg/kg/day (males) 2.1 mg/kg/day (females) UF = 100 (10x inter

- species extrapolation, 10x intra

- species variation

, 10x for route

- to

- route extrapolation from an oral toxicity study) Target MOE occ./res. = 100 0 Chronic T oxicity/Carcinogenicity in Rats (MRID 44380106)

LOAEL (sys.) = 8.8 mg/kg/day (m

. )

11.2 mg/kg/day (f.) based on hi stopathological liver findings Cancer (oral, dermal, inhalation) Classification: “Not likely to be carcinogenic to humans”. No increased incidences in tumors in a

chronic toxicity/carcinogenicity study in the rat or a carcinogenicity study in the mouse

UF = uncertainty factor, NOAEL = no observed adverse effect level, LOAEL = lowest observed adverse effect level, Target MOE = target margin of exposure , PPE = personal protective equipment

. a 12 % dermal absorption factor ( at a dose of 0.04 to 0.4 mg/cm 2 ) was established from an in vivo dermal penetration study in rats (MRID 47154901)

. In lieu of a route

- specific dermal toxicity study, this dermal absorption factor can be applied to an oral NOAEL for dermal risk assessments.Docket Number EPA

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Page 16 of 51 b In lieu of a route

- specific inhalation toxicity study, an additional 10x uncertainty factor for route

- to

- route extrapolation can be applied to an oral NOAEL for inhalation risk assessments.


## 3.2 Dietary Exposure

There is dietary exposure from the use of fenpropimorph on imported bananas. T his exposure was assessed in the 2005 dietary risk assessment (D321866) and the risks are not of concern . In addition there was no significant drinking water exposure from the antisapstain use of fenpropimorph

. As a result, the agenc y does not anticipate requiring a new dietary (food and water) risk assessment

.


### 3.2.1 Food

A risk assessment was previously done for the banana import toleranc es during registration and the a gency concluded the risks were not of concern (D324756)

. There is no d irect or indirect food contact for fenpropimorph as a result of the antisaps t ain use. Therefore, no dietary risk assessment from food containing fenpropimorph is anticipated as being required for the antimicrobial uses.



### 3.2.2 Drinking Water

The potential for drinking water exposure to fenpropimorph from ingestion of surface and ground water in the vicinity of end

- use products is expected to be negligible. The leaching rate of parent fenpropimorph from a rainfall study (MRID 46074205) was low, which is consiste nt with the limited water solubility of 3.5

- 4.3 mg/l (Table 4). Because of the widespread geographical distribution of the treated wood , the low use rate and the low total pounds used per year, residues are expected to be low and dispersed.

The potentia l for drinking water exposure to fenpropimorph from ingestion of surface and ground water in the vicinity of industrial use sites is also not expected. T he sole end

- use label states that wastes must be treated as hazardous waste and disposal must be condu cted according to label instructions, a state pesticide or environmental control agency, or by guidance from a hazardous waste representative. Consequently, down

- the

- drain releases from industrial use of fenpropimorph are not expected to occur

, and no dri nking water exposure is expected to occur.



## 3.3 Occupational and Residential Exposures

The agency anticipate s the need to revise the occupational assessment based on new exposure assumptions for the scenarios presented in the 200 7 occupational exposure assessment (D342435) for the new use of fenpropimorph for wood preservation. Although MOE s did not exceed the a gency’s level of concern for this assessment, the a gency has a new sapstain worker exposure study (MRID 47618301) for calculating the worker exposure s for these scenarios

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Page 17 of 51 

### 3.3.1 Occupational Handler Exposure

EPA does not anticipate the need for additional exposure data. However, EPA does anticipate the need to revise the latest occupational handler assessment that was con ducted during registration in August of 2007. The oc cupational handler dermal and inhalation exposures to fenpropimorph

were initially assessed during registration using surrogate unit exposure data from workers exposed from a n antisapstain worker exposure study for another antimicrobial pesticide (MRID 45524304)

. EPA will use the new sapstain study to revise the assessment. However, the approach to calculate the o ccupational handler exposures for diptank operations, maintenance operations, dry wood operati ons, and wet wood operations will be revised. In all cases, the MOEs for the previous assessment were either not of concern (greater than the target MOE of 100) or mitigated by engineering controls in the previous assessment. During registration review, EP A will conduct a revised assessment with new exposure assumptions that will incorporate scenarios identified in Table 8.

Table 8

– Occupational Handler Exposure Scenarios for Fenpropimorph

Scenario Exposure Route(s) Duration Occupational Exposures Diptank Operations Diptank Tank Operator (gloves) Dermal Inhalation Short and Intermediate

- Term Diptank Tank Operator (no gloves) Dermal Inhalation Short and Intermediate

- Term Maintenance Operations Millwright Dermal Inhalation Short and Intermediate Term Chemical Operator Dermal Inhalation Short and Intermediate

- Term Maintenance (Cleanup Crew) Dermal Inhalation Short and Intermediate

- Term Dry Wood Operations All Dermal Inhalation Short and Intermediate

- Term Wet Wood Operations All Dermal Inhalation Short and Intermediate

- Term


### 3.3.2 Residential Handler Exposures No residential handler exposures are anticipated for the antisapstain wood use.



### 3.3.3 Residential Post

- Application Exposures

A risk assessment will not be conducted for residential post

- application exposures , since minimal
exposures are anticipated for the antisapstain wood use. Antisapstain use is for lumber of interior building materials and millwork. People are not exposed to this l umber because it is typically covered by drywall when used for framing and millwork such as window frames are typically painted.Docket Number EPA

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## 3.4 Aggregate and Cumulative Exposure

3.4.1 Aggregate Exposures

An a ggregate assessment is not necessary since there is no residential or drinking water exposure from the pesticidal use of fenpropimorph

.
3.4.2 Cumulative Exposures

With respect to cumulative exposure, unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, E PA has not made a common mechanism of toxicity finding as to fenpropimorph and any other substances; fenpropimorph does not appear to produce a toxic metabolite produced by other substances. Therefore, f

or the purposes of this registration review

, EPA has not assumed that fenpropimorph has a common mechanism of toxicity with other substances. For information regarding EPA’s efforts to determine which chemicals have a common mechanism of toxicity and to evaluate the cumulative effects of such chemicals, see http://www.epa.gov/pesticides/cumulative/

. 

## 4 Environmental Risk Assessment

A risk assessment for fenpropimorph was completed in 2007 and identified a potential for level of concern ( LOC ) exceedance under a low dilution runoff scenario. 5 Fenpropimorph converts to fenpropimorph acid in the environment and was detected in laboratory sediment studies at up to approximately 10% of initia l fenpropimorph concentration. At that time, the a gency c oncluded that a number of plant toxicity, marine organism, and sediment toxicity studies were outstanding for fenpropimorph.

A second risk assessment was completed in 2009. 6 It used data submitted by the registrant that was required in the 2007 ri sk asses sment and was based on f enpropimorph being used as an antisapstain treatment only, with the restriction that wood must be treated within 24 hours of sawing or cutting. The product label includes the following EPA precautionary statement: “Treated lumber m ust be stored under cover, indoors, or at least 100 feet from any pond, lake, stream, wetland, or river to prevent possible runoff of the product into the waterway. Treated lumber stored within 100 feet of a pond, lake, stream, wetland, or river must be ei ther covered with plastic or surrounded by a berm to prevent surface water runoff into the nearby waterway. If a berm or curb is used around the site, it must consist of impermeable material (clay, asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall events.”

The end

- use labels have statements prohibiting the use of treated wood in beehive construction

. H owever , the agency has determined that this prohibition is not practical. Therefore, during registration review, EPA will work with the registrants to remove these statements. The honeybee acute contact study 850.3020 has been satisfied (MRID 47125501)

. Although the toxicity of residues to honeybees 850.3030 is al so usually required, the agency has determined

5 Petrie et al., 2007

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Page 19 of 51 that for compounds such as fenpropimorph which leach slowly, results of this study are not expected to be pertinent for risk assessment, therefore, this study is not expected to be required. T he honey/beeswax residue study 860.1500

– Magnitude of the residues in honey and beeswax is waived for the proposed antisapstain use.

For the degradate fenpropimorph acid, the registrant submitted t hree acute toxicity studies on freshwater aquatic organisms. The results of these studies are included in Table 9.

MRID 47425202

– Rainbow trout acute static toxicity test using 99.8% fenpropimorph acid. This study is supplemental and does not meet guideline requirements but may be usefu l for risk assessment purposes. The 96 ho ur LC50 was ≥ 100 mg ai/L

.
MRID 47425203

– Green algae acute toxicity test using 99.8% fenpropimorph acid. This study is supplemental and does not meet guideline requirements but may be useful for risk assessment
purposes. The 72 hour EC 50 was ≥ 1 00 mg ai/L

.
MRID 47425204

– Aquatic invertebrate acute toxicity test using 99.8% fenpropimorph acid. This study is supplemental and does not meet guideline requirements but may be useful for risk assessment purposes. The 48 hour EC 50 was ≥ 100 mg ai/L.

These s tudies were submitted to demonstrate that fenpropimorph acid is of lesser toxicity to aquatic organisms than fenpropimorph.

Table 9

– Aquatic Toxicity Values for Parent Fenpropimorph and Fenpropimorph Acid

Species Fenpropimorph

(mg ai/L) F enpropimorph acid (mg ai/L)

Rainbow trout LC 50 ≥ 0.74

– 5.15 LC 50 ≥ 100

Green algae EC 50 = 0.327 EC 50 ≥ 100

Daphnia magna EC 50 = 0.30

- 12.24 EC 50 ≥ 100

The higher acute LC 50 and EC 50 values for fenpropimorph acid relative to parent fenpropimorph in Table 9 indicate that fenpropimorph acid is less toxic to aquatic plants a nd animals than fenpropimorph. It could be assumed that fenpropimorph acid is less toxic on a chronic basis as well , however, no comparative studies are available to confirm this assumption.

The agency has not previously conducted a risk assessment that supports a complete endangered species determination for fenpropimorph

. The ecological risk assessment planned during registration review will allow the agency to determine potential acute and chronic risks to aquatic organisms exposed to fenpropimorph that are transported from treat ed wood into the aquatic environment. The ri sk assessment also will allow the agency to determine whether the antisapstain use of fenpropimorph has 'no effect' or 'may affect' federally listed threatened or endangered species (listed species) or their designated critical habitats. When an assessment concludes that a pesticide’s use 'may affect' a listed species or its designated critical habitat, theDocket Number EPA

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Page 20 of 51 agency will consult with the U.S. Fish and Wildlife Service and/or National Marine Fisheries Services (the Services), as appropriate.



## 4.1 Environmental Fate Assessment

B ased on a wood leaching study using rainfall (MRID 46074205) , f enpropimorph used as an antisapstain product can leach to the environment at low concentrations f or an extended period of time. In the environment, f enpropimorph is relatively water

- insoluble ( Table 4)

, and will largely partition to sediment based on aerobic aquatic metabolism data (MRID 45857318 ). Based on its low vapor pressure and Henry’s law constants, it is unlikely to move from soil or water into air (Table 4). Fenpropimor ph is persistent in aerobic soil (MRID 45857217) but is not mobile (MRID 45857318)

. 7 As a result, transport of parent fenpropimorph by runoff to surface water and by leaching to ground water from treated wood is expected to be limited.

The degradate f

enpr opimorph acid forms from metabolism of parent fenpropimorph in aerobic soil (MRID 45857217 ) and in two aerobic aquatic systems containing both water and sediment (MRID 45868904 ). F enpropimorph acid was not formed at significant quantities ( > 10 % of applied parent compound) in aerobic soil but was formed at significant quantities in the sediment phase from degradation of fenpropimorph and re partitioned to the water phase. F enpropimorph acid was mobile to highly mobile in two soils (MRID 45857318). As a result, transport of fenpropimorph acid to aquatic systems from runoff is expected to be limited, but any parent fenpropimorph in aquatic systems will partition to the water phase as fenpropimorph acid.



### 4.1.1 Leaching from Wood

Pine w ood was treat ed and leached using rainfall. The maximum and average leaching rates were 0.85 and 0.18 μ g/cm 2 /day and the cumulative leaching was 17.9 μ g/cm 2 over a 237 day period (MRID 46074205). Additional data on leaching are not required because the submitted leaching study satisf

ies the data requirement.



### 4.1.2 Water, Sediment , and Soil

Fenpropimorph is stable to hydrolysis (MRID 45857216) and photode gradation in water (46074201). For aerobic aquatic metabolism, t he half

- lives of parent fenpropimorph in two loamy sand systems containin g water and sediment were 54 and 18 days, respectively. The aerobic aquatic half

- lives for the degradate fenpropimorph acid were 121 and 29 days in these aquatic systems , respectively

. R esidues of p arent fenpropimorph were generally higher in sediment than water but water residues were higher for fenpropimorph acid (MRID 45868904). In two soils, p arent fenpropimorph was slightly mobile with Freundlich Kads values of 46 and 79 L/kg and Koc values of 3,833 and 8,778 L/kg in lo amy sand and sand y loam soils. On the other hand, the degradate fenpropimorph acid was mobile to highly mobile with Freundlich Kads

7 Log Koc values of 0

- 2 are mobile to highly mobile and Log Koc values of 3

- 4 a re considered to be slightly mobile ( http://www.fao.org/docrep/003/x2570e/x2570e06.htm )Docket Number EPA

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Page 21 of 51 values of 0.5 and 1 L/kg and Koc values of 42 and 111 L/kg in loamy sand and sandy loam soils (MRID 45857318)

. 8



### 4.1.3 W aste W ater T reatment P lant s (WWTPs) Data for routes of dissipation and toxicity in WWTPs were not submitted , but are not anticipated to be required because fenpropimorph is not expected to be transported to WWTP s. T he sole end

- use label states that wastes must be treated as hazardous waste and disposal must be conducted according to label instructions, a state pesticide or environmental control agency, or by guidance from a hazardous waste representative

.


### 4.1.4 Water Quality
Fenp ropimorph is not identified as a cause of impairment for any water bodies listed as impaired under section 303(d) of the Clean Water Act

. 9 In addition, no Total Maximum Daily Loads (TMDL) have been developed for fenpropimorph

. 10 More information on impair ed water bodies and TMDLs can be found at EPA’s website

. 11



## 4.2 Environmental Exposure Pathways

Based on the antisapstain us e of fenpropimorph in Table 5, the agency has created conceptual

m odels for potential routes of environmental exposure which are included in “Conceptual Models for Environmental Exposure Pathways of Antimicrobial Pesticides

, ” found in the docket
at www.regulations.gov (EPA

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- 001). For the antisapstain use, the relevant
page number is 29. All relevant routes of environmental exposure will be considered in the risk
assessment.

There is no significant ant icipated environmental exposure to fenpropimorph from the wood treatment process because the sole end

- use label states that wastes m ust be treated as hazardous waste and disposal must be conducted according to label instructions, a state pesticide or environmental control agency, or by guidance from a hazardous waste representative.

The treated lumber must be stored under cover, indoor s, or at least 100 feet from any pond, lake, stream, wetland, or river to prevent possible runoff of the product into the waterway. Treated lumber stored within 100 feet of a pond, lake, stream, wetland, or river must be either covered with plastic or surr ounded by a berm to prevent surface water runoff into the nearby waterway. If a berm or curb is used around the site, it must consist of impermeable material (clay, asphalt, concrete) and be of sufficient height to prevent runoff during heavy rainfall even ts.

8 Log Koc values of 0

- 2 are mobile to highly mobile and Log Koc values of 3

- 4 are considered to be s lightly mobile ( http://www.fao.org/docrep/003/x2570e/x2570e06.htm )

9 http://iaspub.epa.gov/tmdl_waters10/attains_nation_cy.cause_detail_303d?p_cause_group_id=885
10 http://iaspub. epa.gov/tmdl_waters10/attains_nation.tmdl_pollutant_detail?p_pollutant_group_id=885&p_pollutant _group_name=PESTICIDES

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## 4.3 Ecological Effects Assessment
The agency has determined that adverse effects to terrestrial animals, aquatic freshwater animals, and green algae are expected to be minim al for the antisapstain use of f enpropimorph. The labeling restrictions listed abov e are expected to protect non

- target species from antisa pstain treated and stored wood. This restricted use pattern would cause minimal exposure to these non

- target organisms. The pr imary degradate, fenpropimorph acid, would not be a risk concern to non

- ta rget organisms based on a lack of toxicity and a lack of exposure (MRIDs 47425202, 47425203 and 47425204)

.


### 4.3.1 Mechanism of Action Fenpropimorph acts by inhibiting egosterol biosynthesis leading to the arresting of cell proliferation in fungi.



### 4.3.2 Measures of Effect (Ecotoxicology Endpoints)

Ecotoxicity endpoint data are used as measures of effects to aquatic and terrestrial organisms. All available ecotoxicity endpoints in the agency ’s files from studies submitted by registrants or other interested parties, f

ederal laboratory data, or from the public literature are tabulated in Appendix C along with the da ta requirements and data gaps. The most sensitive values for each receptor group are used for the risk assessment (Table 10). These selected endpoints will be updated during the risk assessment phase based on any additional submitted data or data found in the public literature.

Table 10

– Ecological Effects Endpoints Selected for Assessing Risks from Fenpropimorph Use

Receptor Group Surrogate Species Risk Scenario Toxicity Endpoint Reference (MRID #)

Freshwater fish Bluegill Sunfish Acute 96

- h LC 50 = 3.25 mg/L 45857205

Rainbow Trout Chronic NOAEC = 0.00016 mg/L 46074303

Freshwater invertebrates Daphnia magna Acute 48

- h EC 50 = 12.24 mg/L 45847207

Chronic NOAEC = 0.082 mg/L 46074305

Freshwater benthic invertebrates Freshwater midge Subchronic/

Chronic 10

- day LC 50 = 13 mg/kg

NOAEC = 4.9 mg/kg 47425201

Estuarine/marine fish Sheepshead minnow Acute Waived

--

Chronic Not required A

--

Estuarine/marine invertebrates Mollusk Acute Waived B

--
Shrimp Acute Waived

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Page 23 of 51 Receptor Group Surrogate Species Risk Scenario Toxicity Endpoint Reference (MRID #)
Chronic Not required A

--

Estuarine/marine benthic invertebrates Marine amphipod Subchronic/

Chronic Waived

--

Algae Green alga Non

- listed 96

- hr EC 50 = 0.327 mg/L 45868903

Listed

--

Aquatic vascular plants Duckweed Non

- listed Waived

--

Listed

--

Seedling Emergence Red clover Non

- listed Waived

--

Listed

--

Vegetative vigor Canola Non

- listed Waived

--

Listed

--

Birds Northern bobwhite

quail Acute LD 50 ≥ 2000 mg/kg 45868901

Mallard duck Subacute

dietary LC 50 = 5000 mg/kg 45857204

Chronic Not required A

--

Mammals Acute NOAEL = 30 mg/kg/day 43471604

Chronic NOAEL = 16 mg/kg/day 45756501

Non

- target insects Honey bee Acute Oral LC 50 ≥ 95.6 ug ai/bee

Contact LC 50 ≥ 100 ug ai/bee 47125501

A Not required for this use pattern.

B Waived for this chemical based on its use as an a ntisapstain wood preservative. This limited use pattern would lead
to little if any exposure to non

- target organisms.



## 4.4 Exposure Analysis Plan

4.4.1 Aquatic and Terrestrial Wildlife Exposure Estimates

The agency intends to conduct a risk assessme nt for fenpropimorph from the in

- service use of treated wood

. This in

- service risk assessment may be qualitative based on: (1) widespread geographical use of treated wood, (2) low application rate, (3) the treatment is int ended forDocket Number EPA

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Page 24 of 51 protection in transit, and (4) in structures, most wood is painted or stained which would reduce leaching. Further, as a practical matter, antisapstain treated wood is not intended to protect wood in aquatic environments. Docks and piers would be constructed from pressure treated wood.

Typically, wood treatment uses can result in down the drain releases from treatment and storage of wood. However, for fenpropimorph, t he agency does not intend to conduct a risk assessment from treatment and stora ge of wood at industrial use sites because the sole end

- use label states that wastes must be treated as hazardous waste and disposal must be conducted according to label instructions, a state pesticide or environmental control agency, or by guidance from a hazardous waste representative. Consequently, down

- the

- drain releases from industrial use of fenpropimorph are not expected to occur.



### 4.4.2 Screening Level Down

- the

- Drain Analysis The agency does not anticipate the need for a Down

- the

- Drain (DtD) assessment because the sole end

- use label states that wastes must be treated as hazardous waste and disposal must be conducted according to label instructions, a state pesticide or environmental control agency, or by guidance from a hazardous waste repres entative.



## 4.5 Effects Analysis Plan

Open literature studies will be identified through EPA’s ECOTOXicology (ECOTOX) database. The ECOTOX database will be searched when the risk assessment is prepared. Any acute or chronic endpoints that are more sensitive than what is currently available will be used in the risk
assessment.


## 5 Endocrine Disruptor Screening Program (EDSP)

As required by FIFRA and FFDCA, EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Colle ctively, these studies include acute, subchronic and chronic toxicity, including assessments of carcinogenicity, neurotoxicity, developmental, reproductive, and general or systemic toxicity. These studies include endpoints which may be susceptible to endoc rine influence, including effects on endocrine target organ histopathology, organ weights, estrus cyclicity, sexual maturation, fertility, pregnancy rates, reproductive loss, and sex ratios in offspring. For ecological hazard assessments, EPA evaluates acu te tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of the 1998 registration action , for fenpropimorph , EPA reviewed these data and selected the most sensitive en dpoints for relevant risk assessment scenarios from the existing hazard database. However, as required by FFDCA section 408(p), f enpropimorph is subject to the endocrine screening part of the Endocrine Disruptor Screening Program (EDSP).

EPA has developed the EDSP to determine whether certain substances (including pesticide active and other ingredients) may have an effect in humans or wildlife similar to an effect produced by a “naturally occurring estrogen, or other such endocrine effects as the Administr ator may designate.” The EDSP employs a two

- tiered approach to making the statutorily required determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of aDocket Number EPA

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Page 25 of 51 chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go through Tier 1 screening and are found to have the potential to interact with E, A, or T hormonal systems will proceed to the next stage of the EDSP where EPA will determine which, if any, of the Ti er 2 tests are necessary based on the available data. Tier 2 testing is designed to identify any adverse endocrine

- related effects caused by the substance, and establish a dose

- response relationship between the dose and the E, A, or T effect.

Under FFDCA section 408(p), the agency must screen all pesticide chemicals. 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 9 inert ingredi ents. A second list of chemicals identified for EDSP screening was published on June 14, 2013 12 and includes some pesticides scheduled for registration review and chemicals found in water

. Neither of these lists should be construed as a list of known or lik ely endocrine disruptors.

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. 13


## 6 Optional Label Changes

The age ncy invites any label amendments that could be considered to eliminate the anticipated need for EPA to require certain data, reduce the possibility that EPA’s planned risk assessment s overestimate risk due to reliance on conservative assumptions , and/or improve label clarity. During registration review, EPA intends to work with registrants to modify labels to remove unenforceable statements regarding how treated wood is to be used as discussed in Section 4

. 

## 7 Next Steps

A DCI will be developed regarding the data needs listed under the “Anticipated Data Needs” section of this document. The agency expects to issue the DCI by March 2016

.

12 See http://www.regulations.gov/#!documentDetail;D=EPA

- HQ

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- 2009

- 0477

- 0074 for the final second list of chemicals.
13 http://www.epa.gov/endo/Docket Number EPA

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## 8 References

Chemical Book. 2010. Fenpropimorph Acid. , http://www.chemicalbook.com/ChemicalProductProperty_EN_CB72545117.htm

EPI

- WEB 4.11. 2012. U.S. EPA. http://www.epa.gov/oppt/exposure/pubs/episuitedl.htm

Pesticide Action Network. 2014. Fenpropimorphic Acid. http://www.pesticideinfo.org/Detail_Chemical.jsp?Rec_Id=PC41987

Collantes, M. and Drew, W. February 10, 2006. REVISI ON : Clarification of Data Requirements for Fenpropimorph. Human Health Risk Assessment to Support Tolerance on Imported Bananas. DP Barcode 326756.

Lindheimer, T. August 2, 2007. Revised Occupational Ex posure Assessment of Proposed New Use of Fenpropimorph (121402) Formulation for Wood Preservation. DP Barcode 342435.

Petrie, R., Mostaghimi, S., and Gowda, S. July 12, 2007. Ecological Risk a nd Fate Assessment for fenpropimorph (Wolsin® FL 35) New Chemical Wood Preservative Antisapstain Use

. DP Barcodes D 333166, D 333168, D 333170, D 333171

Petrie, R. February 10, 2009. Review of Studies and Ecotoxicity Data Waiver Requests for the Conditional Registration of the Antisapstain Use of fenpropimorph (W olsin® FL 35) . DP Barcodes D3 50203, D 353064

U.S. Environmental Protection Agency (EPA). 2002. ECOTOX User Guide: ECOTOXicology Database System. Version 3.0. Available: http://www.epa.gov/ecotox/

U.S. Environmenta l Protection Agency (EPA). March 2006. Pesticide Fact Sheet, Fenpropimorph New Chemical Tolerance Established.Docket Number EPA

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Page 27 of 51 

# Appendix A T oxicology Profile

Acute Toxicity for Product Labeling

Acute toxicity profile for technical fenpropi morph is presented in Table A 1. Fenpropimorph has low acute toxicity via the oral, dermal and inhalation routes of exposure (Toxicity Category III and IV ). Acute eye irritation testing resulted in classification of this active ingredient as Toxicity Category II. The acute dermal irri tation study in rabbits showed severe irritation after one hour

e xposure (Toxicity Category I). Fenpropimorph is a skin sensitizer in the Beuhler Guinea pig
assay. There is no evidence of delayed neurotoxicity in hens following exposure to fenpropimorph.

Table A1

– Acute Toxicity Studies for Fenpropimorph

Guideline Number Study Type MRID Number Results Toxicity Category 870.1100 Acute Oral

– Rat 45857208 LD 50 = 2,830 mg/kg (males) 1,670 mg/kg (females) 2,230 mg/kg (combined) III

870.1100 Acute Oral

– Rat 45857209 LD 50 = 3,650 mg/kg (males) 3,425 mg/kg (females) 3,515 mg/kg (combined) III

870.1200 Acute Dermal

– Rat 45857210 LD 50 > 4,000 mg/kg (males, females) > 4,000 mg/kg (combined) III

870.1300 Acute Inhalation

- Rat 45857211 LC 50 = 3.7 mg/L (males) LC 50 = >2.2, <2.4mg/L (females) LC 50 = 2.9 mg/L (combined) IV

870.2400 Acute Eye Irritation

- Rabbit 45857212 Redness (no observation between 72 hours and day 8) I a

870.2500 Acute Dermal Irritation

- Rabbit 45857213 Severely irritating after 1 hour exposure I a 870.2600 Skin Sensitization

–

Guinea pigs (Buehler Method) 45857214 Skin sensitizer N / A

N / A = N ot applicable

a Also classified as “No worse than Toxicity Category II” 

## Subchronic Toxicity

The liver was affected by the administration of fenpropimorph in subchronic toxicity studies. In one 90

- day rat study (MRID 44380105), the LOAELs were 7.1 and 8.5 mg/kg/day for males and females, respectively, based upon decreases in body weights and body weight gains in both sexe s as well as an increase in absolute and relative liver weights in males and increases in only rela tive liver weights in females. In this study, the NOAELs were 0.7 and 0.8 mg/kg/day for

ma les and females, respectively. A second 90

- day rat toxicity study ( MRID 44380103) reported an increase in liver weights at doses of 1.54 mg/kg/day in males and 1.80 mg/kg/day in females (HDT); however, no other effects in the liver of these animals were noted.

Although a dermal toxicity range

- finding study in rats (MRID 4 4380104) was conducted with fenpropimorph, this study was not appropriate for risk assessment purposes because neither anDocket Number EPA

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Page 28 of 51 irritation nor a systemic toxici ty LOAEL could be established. The highest dose tested (2 mg/kg/day) represented the maximum dose of t est material that would not produce severe irritation, making the dose selection inadequat e for a dermal toxicity study. For registration review, a repeat dermal absorption study in not anticipated to be needed; the dermal absorption factor of 12% can be a pplied to an oral NOAEL for dermal risk assessments.
An inhalation toxicity study was no t conducted for fenpropimorph. However, an additional 10x uncertainty factor for route

- to

- route extrapolation can be applied to an oral NOAEL for inhalation risk asses sments in lieu of a route

- spe cific inhalation toxicity study. 

## Developmental Toxicity

In a rat developmental toxicity study (MRID 44380108), the maternal NOAEL was 40 mg/kg/day with a LOAEL of 160 mg/kg/day based upon vaginal bleeding and decreased body

we ight an d body weight gain. The same numerical NOAEL and LOAEL were reported for developmental toxicity in this study with the following being observed at the LOAEL dose of 160 mg/kg/day: decreased number of live fetuses/dam, increased resorptions, increase d % post

implantation loss and increased incidence of cleft palate. In a second rat development toxicity study (MRID 44323912) in which dosing began during gestation and continued through lactation (GD 15 through PND 21), the maternal NOAEL was 10 mg/kg/da y with a maternal LOAEL of 40 mg/kg/day based up on decreased body weight gain. For the developmental portion of the study, the NOAEL was also 10 mg/kg/day with a LOAEL of 40 mg/kg/day based upon a decrease in the number of live fetuses/dam, an increase in post

- implantation loss. Decreased mean litter size, decreased number of live pups a nd decreased survival indices. In addition, decreases in grip strength were observed in female fetuses as part of the protocol for this developmental/neurotoxicity toxicity in rats. However, there was no visceral or skeletal examination of fetuses/pups conducted in this combined study.

There were two developmental rabbit studies conducted with fenpropimorph. In the study conducted in 1993 (MRID 44323914), the maternal NOAE L was 15 mg/kg/day with a LOAEL of 30 mg/kg/day based upon 9/20 dams showing swe lling of the anus on GD 15

- 29. The developmental NOAEL was also 15 mg/kg/day with a LOAEL of 30 mg/kg/day based upon increased incidence of cleft palate (4/116 fetuses; 2/20 li tte rs; 0 in concurrent controls). In the earlier study (MRID 44323913), the maternal NOAEL was 12 mg/kg/day and the LOAEL was 36 mg/kg/day based upon increased mortality, abortions a nd clinical signs of toxicity. The developmental NOAEL was 12 mg/kg/day an d the LOAEL was 36 mg/kg/day based upon increased incidence of resorptions, external anomalies and skeletal variations/retardation. 

## Reproductive Toxicity

In the 2

- generation reproduction study in rats (MRID 44323915), the NOAELs for parental, reproductive and offspring toxicity were the highest dose tested (2.04 and 2.79 mg/kg/day for

ma les and female, respectively). Thus, LOAELS were not established in th is study. Animals were not dosed high enough as the dose selection was based upon increased relative liver weights in a 90

- d ay oral toxicity study in rats. Although a maternal, reproductive and offspring LOAEL could not be established, this study was classified as Acceptable/Non

- guideline.Docket Number EPA

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## Chronic Toxicity

In the chronic toxicity rat study (MRID 44380106 ), the LOAELs for liver findings were 1.7 and 2.1 mg/kg/day for ma les and females, respectively. No liver effects were noted in the 90

- day dog study at doses up to 11.63 mg/kg/day for males and 14.64 mg/kg/day for females. However, in the 12

- month dog stud y (MRID 44323911) , the NOAEL was 3.2 mg/kg/day (both sexes) with the LOAELs being 12.3 and 13.2 mg/kg/day for males and females, respectively, based upon ≥ 200% increase in a lanine aminotransferase (ALT). No liver changes were reported for any of the othe r toxicity studies in the fenpropimorph database. 

## Carcinogenicity

In accordance with the EPA Draft Guidelines for Carcinogen Risk Assessment (July, 1999), fenpropimorph was classified as, “not likely to be carcinogenic to humans

. ” There were no increased incidences of benign or malignant tumors in the rat chronic toxicity/carcinogenicity study (MRID 44380106) or the mouse carcinogenicity study (MRID 44380107) conducted with fenpropimorph. 

## Mutagenicity

A complete battery of mutagenicity studies was negati ve for fenpropimorph in a reverse gene mutation study in Salmonella typhimurium (MRID 44323917), an in vitro mammalian chromosome aberration study in Chinese hamster lung cells (MRID 44323919), an in vivo mammalian cytogenetic micronucleus assay in mice (M RID 44323918) and an unscheduled DNA synthesis assay in primary rat hepatocytes/mammalian cell cultures (MRID 44323916). 

## Other Toxicological Effects

Neurotoxicity Battery

Effects of administration of fenpropimorph were on a variety of measu red nervous sys tem parameters. In two 90

- day rat studies (MRID 44380103, 44380105), there were decreases in

serum /plasma cholinesterase levels. However, these serum/plasma values are not considered relative for risk assessment purposes. In addition, there were decreases in brain cholinesterase levels a t 2.1 mg/kg/day in both sexes. Regarding a mouse carcinogenicity study (MRID 44380107), in females only, the NOAEL for RBC cholinesterase was 0.5 mg/kg/day with a LOAEL of 3.5 mg/kg/day. These cholinesterase effects were not considered in choosing NOAELs or LOAELs because of the inconsistency of the results (i.e. no clear dose

- response relationship) among studies, s pecies and controls. No apparent effect on cholinesterase levels

was noted in dogs (MRID 44323911). Additional n ervous system effects were reported in the acute neurotoxicity study in rats (MRID 44323910) where the NOAELs for males and females were 500 mg/kg and the LOAELs were 1500 mg/kg based upon piloerection plus dilation of the ventricles of the brain observed in one male and piloerection plus dilation of the ventricles of the brain with overall decreased motor activity in one female.
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Page 30 of 51 A developmental neurotoxicity study is not anticipated to be required because neurotoxicity parameters were affected only at very high doses, considerably higher than the NOAELs and RfDs established for developmental effects (i.e. cleft palate) in the acute dietary endpoint and liver

- related changes in the chronic dietary endpoint. Therefore, the acute and chronic dietary endpoints established for fenpropimorph will provide a margin of safety of 500 times lower for acute and 2000 times lower for chronic effects before any significant ne urotoxic effects are observed. For registration review of the antimicrobial wood preservative uses of fenpropimorph only, acute and chronic dietary risk assessments are not needed.

Metabolism and Pharmacokinetics
In a rat metabolism and pharmacokinetic study (MRID 44323920), 96

- 110% of the radioactivity

was recov ered within 96 hours of dosing. High levels were found in feces of intravenous dosed rats (45

- 49%), indicating biliary excretion as a major route of eli mination. In bile

- duct cannulated rats, most of the d ose was recovered in th e bile. After oral dosing, high levels were recovered in the urine and bile, indication absorption from t he gastrointestinal (GI) tract. No parent compound was found in the urine, feces or bile; fenpropimor ph was completely metabolized. Fenpropimorph metab olism appears to involve oxidation of the tert

- butyl group on the phenyl ring to form the acid metabolite BF 421

- 2, which is hydroxylated to yield the major metabolite BF 421

- 3

. Most of the radioactivity in bile (56

- 69%) was made up of many unknown
compone nts. The presence of unknown components in bile, suggest that metabolites which are initially excreted, undergo further metabolism and reabsorption prior to final elimination in urine and feces. Several major metabolites (>5% of the administered dose) were detected in urine and feces.

Dermal Penetration

In an in vivo dermal penetration study (MRID 47154901) designed to approximate field conditions, an absorption factor of 12% was estimated in the rat based on an 8

- hour exposure at a dose of 0.04 to 0.4 mg/c m 2 fenpropimorph. Although this study does not satisfy the guideline requirement for a dermal penetration study in rats, it is classified acceptable/non

- guideline because it provides sufficient information for estimation of a dermal penetration factor that can be applied to an oral NOAE L for dermal risk assessments. No dermal toxicity study is anticipated to be required for fenpropimorph.

References

MRID 44323910

. Mellert, W.; Kaufmann, W.; Hildebrand, B. (1997) Acute Oral Neurotoxicity of Fenpropimorph in Wistar Rats: Lab Project Number: 97/10592: 20C0047/93061. Unpublished study prepared by BASF Aktiengesellschaft. 420 p.

MRID 44323911

. Hellwig (1990) Report on the Study of Fenpropimorph in Beagle Dogs. Administration via the Dier over 12 months: Lab Pr oject Number: 90/0172: 33D0133/87021. Unpublished study prepared by BASF Aktiengesellschaft. 842 p.Docket Number EPA

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Page 31 of 51 MRID 44323912

. Hoffmann, T.; Merkle, J. (1979) Study of the Prenatal and Postnatal Toxicity of Fenpropimorph in Rats: Lab Project Number: 79/10164: T282R. Unpublished study prepared by BASF Aktiengesellschaft. 344 p.

MRID 44323913

. Zeller, H.; Merkle, J. (1980) Study to Determine the Prenatal Toxicity of Fenpropimorph in Rabbits: Lab Project Number: 80/0109: T316K. Unpublished study prepared by BASF Aktiengesellschaft. 258 p.

MRID 44323914

. Marty, J. (1993) CGA 101 031 (Fenpropimorph) Technical: Rabbit Oral Teratoge nicity: (Final Report): Lab Project Number: 93/11016: 923154. Unpublished study prepared by Ciba

- Geigy. 263 p.

MRID 44323915

. Merkle, J. (1982) Report on a Reproduction Study with Fenpropimorph in the Rats After Oral Administration (Feeding): 2

- Generatio n Study: Lab Project Number: 82/079. Unpublished study prepared by BASF Aktiengesellschaft. 1152 p.

MRID 44323916

. Cifone, M. (1988) Report on the Mutagenicity Test on Fenpropimorph in the Rat Primary Hepatocyte Unscheduled DNA Synthesis Assay: (Revised Final Report): (Includes Phase 3 Summary): Lab Project Number: 88/0210: 10001

- 0

- 447: 61M0133/879008. Unpublished study prepared by Hazleton Labs America, Inc. 37 p.

MRID 44323917

. Engelhardt, G. (1994) Report on the Study of Fenpropimorph in the Ames
Tes t (Salmonella/Mammalian

- Microsome Mutagenicity Test

- Standard Plate Test and Preincubation Test): Project Lab Number: 94/10180: 40M0047/934047: 934047. Unpublished study prepared by BASF Aktiengesellschaft. 40 p.

MRID 44323918

. Engelhardt, G. (1994) Cytog enetic Study in vivo of Fenpropimorph in Mice Micronucleus Test: Single Intraperitoneal Administration: (Includes Phase 3 Summary): Lab Project Number: 94/10966: 26M0047/934049. Unpublished study prepared by BASF Aktiengesellschaft. 72 p.

MRID 44323920

. van Dijk, A. (1989) (Carbon 14)

- RO 14/3169: Absorption, Distribution, Excretion, and Metabolism after Single Oral Intravenous, Single Oral, and Repeated Oral Administration to the Rat: Lab Project Number: 89/0315: 063641. Unpublished study prepared by RCC Umweltchemie AG. 413 p.

MRID 44380103

. Kirsch, P. (1979) Study of the Toxicity of Fenpropimorph (Reg. No. 108 406) on Rats in a 3

- Month Feeding Experiment: Lab Project Number: 79/079. Unpublished study prepared by BASF Aktiengesellschaft. 738 p.

MRID 4 4380104

. Kirsch, P. (1979) Study of the Toxicity of Fenpropimorph (Reg. No. 108 406) in Beagle Dogs in a 3

- Month Feeding Experiment: Lab Project Number: 80/0171. Unpublished study prepared by BASF Aktiengesellschaft. 487 p.Docket Number EPA

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Page 32 of 51 MRID 44380105

. Mellert, W.; De ckardt, K.; Kaufmann, W. et al. (1997) Subchronic Oral Toxicity and Neurotoxicity of Fenpropimorph (Reg. No. 108 406) in Wistar Rats Administration in the Diet for 3 Months: Lab Project Number: 97/10591: 50C0047/93057. Unpublished study prepared by BASF A ktiengesellschaft. 720 p.

MRID 44380106

. Hunter, B.; Barnard, A.; Hayman, R. et al. (1982) Fenpropimorph (Reg. No. 108 406): Assessment of Potential Tumorigenic and Toxic Effects in Prolonged Dietary Administration to Rats: Lab Project Number: BAF/308/81138: 82/092. Unpublished study prepared b y Huntingdon Research Centre. 1974 p.

MRID 44380107

. Hunter, B.; Heywood, R.; Hayman, R. et al. (1982) Fenpropimorph (Reg. No. 108 406): Assessment of Potential Tumorigenic Effects in Prolonged Dietary Administration to Mice: Lab Project Number: BAF/320/8 1746: 82/142: BSF/320. Unpublished study prepared by Huntingdon Research Centre. 1201 p.

MRID 44380108

. Hofmann, H. (1978) Investigation to Determine the Prenatal Toxicity of Fenpropimorph (Reg. No. 108 406) in Rats: Lab Project Number: 78/043. Unpublis hed study prepared by BASF Aktiengesellschaft. 141 p.

MRID 45857208

. Gelbke (1978) Report about the Acute Oral Toxicity of the Preparation Reg. No. 108 406 in Rats: Lab Project Number.: 78/0144: BASF/78/0144: 77/960 Unpublished study prepared by BASF Akti engesellschaft, Gewerbehygiene und Toxikologie. 11 p.

MRID 45857209

. Leuschner, F. (1978) The Acute Oral Toxicity of the Preparation Reg. No. 108 406 in Rats: Lab Project Number: 78/042: BASF/78/042: 78/164

- 1. Unpublished study prepared by Laboratorium fur Pharmakologie und Toxikologie. 14 p.

MRID 45857210

. Jackh, D. (1982) Report on the Study a bout the Acute Dermal Toxicity of "Reg. No. 108406" in the Rat: Lab Project Number: 82/026: BASF/82/026. Unpublished study prepared by BASF Ag. 6 p.

MRID 45857211

. K limisch, H.; Zeller, H. (1979) Determination of the Acute Inhalation Toxicity LC50 of Fenpropimorph (Reg. No. 108406) as a Liquid Aerosol a fter 4

- Hour Exposure in Sprague

- Dawley Rats: Lab Project Number: 79/072: BASF/79/072. Unpublished study prepared by B ASF Ag, Gewerbehygiene und Toxikologie. 22 p.

MRID 45857212

. Grundler, O. (1980) Report on the Study of the Primary Irritation of "Reg. No. 108406" on the Eye of White Rabbits: Lab Project Number: 80/0170: BASF/80/0170: 79/356. Unpublished study prepared b y BASF Aktiengesellschaft, Gewerbehygiene und Toxikologie. 9
p.

MRID 45857213

. Grundler, O.; Leuschner, F. (1980) Primary Dermal Irritation of Fenpropimorph Techn. on the Rabbit Skin: Lab Project Number: WOL/80/04/10: 79/356: BASFDocket Number EPA

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Page 33 of 51 80/0212. Unpublished stud y prepared by Laboratorium fur Pharmakolgie und Toxikologie and BASF Aktiengesellschaft. 18 p.

MRID 45857214

. Gelbke, D. (1979) Dermal Sensitization Study on the Guinea Pig According to the Maximization Test: (Fenpropimorph): Lab Project Number: 79/0121: B ASF/79/0121. Unpublished study prepared by BASF Ag, Gewerbehygiene und Toxikologie. 13 p.

MRID 47154901

. Schwartz, R. (2007) Studies of the Dermal Resorption of (Carbon 14)

- Fenpropimorph. Project Number: WOL/07/2905. Unpublished study prepared by Dr. Wolma n GmbH. 125 p.Docket Number EPA

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Page 34 of 51 

# Appendix B Environmental Fate

Environmental Fate and Transport Properties of Fenpropimorph and its Microbial Degradate Fenpropimorph Acid.

Past environmental fate assessment s addresse d the persistence and mobility of parent fenpropimorph, cis

- 4

- [3

- (p

- tert

- butylphenyl)

- 2

- methylpropyl]

- 2,6

- dimethylmorpholine one and the degradate fenpropimorph acid (fenpropimorph carboxylic acid)

.
The sole end

- use product (EPA Reg. No. 71406

- 4, 5.4 % fenpropimorph , CAS No. 121098

- 45

- 1 ) is intended to preserve lumber that can be used in fresh water habitats but not marine or estuarine habitats. However, the label does not restrict uses that are or can be submersed in water or in structures that overlay water such as docks and piers. As a result, the agency assumes that aquatic exposure from treated wood can occur directly by leaching created by rainfall a nd submersion of exposed wood. The agency also assumes that aquatic exposure can occur from leaching of fenpropimorph from treated woo d that is created by rainfall. Leached fenpropimorph from treated wood used in terrestrial areas can reach surface water by either runoff on the soil surface or by downward movement into the soil which reaches ground water that is in contact with surface wa ter.
Based on a wood leaching study (MRID 46074205), fenpropimorph used as an antisapstain product can leach at low concentration to the environment for an extended period of time. Fenpropimorph is relatively water

- insoluble (Table 4), but will be prese nt in both sediment and water based on aerobic aquatic m etabolism data (MRID 45857318). Based on its low vapor pressure (6.5 x 10

- 6 mm Hg, Table 4), it is unlikely t o vaporize from soil into air. Based on its low Henry’s Law constant (6 x 10

- 6 atm m 3 mol

- 1 ), fenpropimorph is unlikely to volatilize f rom water into air (Table 4). Parent fenpropimorph was slightly mobile in soil with Freundlich Kads values of 46 and 79 L/kg and Koc values of 3,833 and 8,778 L/kg in loamy sand and sandy loam soils (MRID 4585731 8).

Fenpropimorph can dissociate to form fenpropimorph acid, and the disassociation constant (pKa) for fenpropimorph is 7 (Table 4). The pKa is the pH at which 50 % of a substance is non

- ionized (non

- dissociated) and 50 % is ionized (disassociat ed). At pH levels below the pKa, a compound will exist primarily as the non

- ionized form and will exist primarily as t he ionized form above the pKa. Consequently, at most pH values (pH 5

- 7), parent fenpropimorph will exist predominantly as the parent compound (non

- i onized) and not as fenpropimorph acid (ionized). However, in areas that are calcareous (pH ~8.3) or sodic (pH ~9), fenpropimorph acid will eventually become the primary chemical specie.

Fenpropimorph acid forms from metabolism of fenpropimorph in aerob ic soil (MRID 45857217) and in two aerobic aquatic systems containing both water and sediment (MRID 45868904). Aerobic soil metabolism studies represent the degradation of a chemical in the oxygenated top layer of soil, and aerobic aquatic metabolism stud y represent degradation and partitioning of a chemical that occurs in an oxygenated surface water system that contains sediment. Based onDocket Number EPA

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Page 35 of 51 aerobic soil metabolism study results, fenpropimorph acid was not formed at significant quantities (>10 % of applied p arent com pound) in the soil environment. Based on aerobic aquatic metabolism study results, however, it was formed at significant quantities in the sediment phase from degradation of fenpropimorph and rep artitioned to the water phase. Fenpropimorph acid

wa s mobile to highly mobile with Freundlich Kads values of 0.5 and 1 L/kg and Koc values of 42 and 111 L/kg in loamy sand and sandy loam soils (MRID 45857318).

Water and Sediment

Hydrolysis

Fenpropimorph is stable to hydrolysis at pH 3, 5, 7, and 9 (MRID 45857216)

. Aqu eous Photoly s is

Data have not been submitted, but the limited sorption of UV/visible light by fenpropimorph above 290 nm of wavelength (MRID 46074201) is expected to prevent direct photodegradation in water.

Octanol

- Water Partition Coefficien t
The log Kow of fenpropimorph is 4.1 (>3), which indicates that sorption to soil and sediment and bioconcentration in fish and other aquatic organisms is likely

. (MRID 45857203).

Aerobic Aquatic Metabolism

The half

- lives of parent fenpropimorph in two loa my sand systems containing both water and sediment were 54 and 18 days, respectively. The half

- lives for the degradate fenpropimorph acid were 121 and 29 days in these aquatic systems , respectively. Aqueous residues of parent fenpropimorph were higher for water than sediment for 2

- 7 days and sediment residues were higher for the remainder of the study (up to 100 days). On the other hand, aqueous residues of fenpropimorph acid were higher for water tha n in sediment throughout the study because it is more polar than the parent compound (MRID 45868904).

Soil

Soil Leaching/Adsorption/Desorption Batch Equilibrium

Parent fenpropimorph was slightly mobile with Freundlich K ads values of 46 and 79 L/kg and Ko c values of 3,833 and 8,778 L/kg in loamy sand and sandy loam soils

. On the other hand, the degradate fenpropimorph acid was mobile to highly mobile with Freundlich K ads values of 0.5 and 1 L/kg and Koc values of 42 and 111 L/kg in loamy sand and sandy loa m soils (MRID 45857318)

. 15

15 Log Koc values of 0

- 2 are mobile to highly mobile and Log Koc values of 3

- 4 are considered to be slightly mobile ( http://www.fao.org/docrep/003/x2570e/x2570e06.htm )Docket Number EPA

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Page 36 of 51 Aerobic Soil Metabolism

Fenpropimorph only slight degraded in aerobic soil with half

- lives of 364

- 433 and 518

- 545 days in loamy sand and s andy loam soils, respectively. No significant degradation products were detected (MRID 45857217).

Leaching from Treated Wood

Pine w ood was treat ed and leached using rainfall. The maximum and average leaching rates were 0.85 and 0.18 μ g/cm 2 /day and the cumulative leaching was 17.9 μ g/c m 2 over a 237 day period (MRID 46074205). Additional data on leaching are not anticipated to be required because the only use of fenpropimorph is an antisapstain, which is expected to create low concentrations over a long period of time based on the limite d water solubility of 4.32 mg/l (Table 4).

Fate and Transport in WWTP

Data for routes of dissipation and toxicity in WWTPs were not submitted

. However, data on the environmental fate of fenpropimorph in WWTPs are not anticipated to be required because the sole end

- use label states that wastes must be treated as hazardous waste and disposal must be conducted according to label instructions, a state pesticide or environmental control agency, or by guidance from a hazardous waste representative.

Table B 1. Status of Fenpropimorph Environmental Fate Studies

Test Guideline (parent compound unless stated) OCSPP

Guideline No. Study result Significant Degradation Products 16 Study status Reference (MRID) and Comments

Hydrolysis 835.2120 Stable at pH 3, 5, 7, and 9 None Acceptable 45857216 Rudel, 1988 25 o C Gowda, Nov. 8, 2006a review Photodegradation in water by sunlight 835.2210 No data Not applicable Not required Limited UV/Visible sorption above 290 nm (MRID 46074201) Aerobic soil metabolism 835.4100 363

- 433 and 518

- 545 days in loamy sand and sandy loam soil 1
ppm, respectively 17

213

- 284 and 441

- 579 days in loamy sand None Acceptable 45857217 Rudel, 1989 25 o C Gowda, Nov. 8, 2006b review 5 ppm rate used for degradate identification only and not for persistence

16 Significant degradates formed at > 10 % of applied parent compound

17 Non

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Page 37 of 51 and sandy loam soils at 5
ppm, respectively. estimates in risk
assessment

Anaerobic aquatic metabolism 835.4400 No data Not applicable Not required None

Aerobic aquatic metabolism 835.4300 54 and 18 day half

- lives in
two loamy sand water:sediment systems 18 121 and 39 day

half

- lives in two loamy sand water:sediment systems Acceptable 45868904 Degradate was Fenpropimorph acid Ebert, 2000 20 o C Gowda, Nov. 8, 2006c review

Leaching

Adsorption

Desorption (unaged) 835.1230 Kd values of 46 and 79 L/kg in loamy sand and sandy loam soils

Koc values of 3,833 and 8,778 L/kg Kd values of 0.5

and 1 L/kg in loamy sand and sandy loam soils (Fenpropimorph acid)

Koc values of 42 and 111 L/kg Supplemental 45857318 Stockmaier, 1996 Gowda, Nov. 8, 2006d review

Aged leaching

adsorption

desorption of Fenpropimorph acid 835.1230 No further data required No further data

required Supplemental 45867318 Stockmaier, 1996 Temp? Gowda, Nov. 8, 2006d review Bioconcentration in Fish 850.1730 No data Not applicable for degradate fenpropimorph acid Required for

parent fenpropimorph 19 None

Leaching from treated wood OECD Draft

CEN/TR 15119 Data not used Not applicable Unacceptable 47010801 Hantzschel, 2006 Gowda, Nov. 8, 2006e review Study rejected because of incorrect protocol AWPA E11

- 06 Leaching rates

(ug/cm 2 /day) 0.85 (max) 0.18 (average) 0.00047 (min) No data Supplemental 46074205 Maier, 2003

Gowda, Nov. 8, 2006f review

18 Non

- linear regression using days (x) and total of % applied parent compound (y) from water and sediment from all intervals
19 Based on log Kow (Log P) of 4.1 (>3), 850.1730 data are required for parent fenpropimorphDocket Number EPA

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Page 38 of 51 Cumulative leaching (ug/cm 2 ) 17.9 (average) References

Ebert, D. 2000. Degradation of BAS 421 F in Water/Sediment Systems under Aerobic Conditions: (Final Report): Lab Project Number: 2000/1000146: BASF/2000/1000146: 58000. Unpublished study prepared by BASF Ag. 104 p. MRID 45868904

Food and Agriculture Orga nization of the United Nations. APPENDIX 2 : Parameters of pesticides that influence processes in the soil

. http://www.fao.org/docrep/003/x2570e/x2570e06.htm

Gowda, S. November 8, 2006a. Review of the study, Hydrolysis studies on BAS 421 F at pH 3, 5, 7, and 9, to Support the Application for New Registration of End Use Product, Wolsin® FL 35 Antisapstain containing the active ingredients, 5.4% Fenpropimorph, 2.7% Propiconazole and 9% Bori c acid, EPA File Symbol 71406

- U. D333168

Gowda, S. November 8, 2006b. Review of the study, Aerobic Metabolism Studies of BAS 421 F, to Support the Application for New Registration of End Use Product, Wolsin® FL 35 Antisapstain containing the active ingr edients, 5.4% Fenpropimorph, 2.7% Propiconazole and 9% Boric acid , EPA File Symbol 71406

- U. D333168

Gowda, S. November 8, 2006c. Review of the study, Degradation of BAS 421 F in Water/Sediment Systems under Aerobic Conditions to Support the Application for New Registration of End Use Product, Wolsin® FL 35 Antisapstain containing the active ingredients, 5.4% Fenpropimorph, 2.7% Propiconazole and 9% Boric acid, EPA File Symbol 71406

- U. D333168

Gowda, S. November 8, 2006d. Review of the study published in an article, Investigations on the Behaviour of Fenpropimorph and its Metabolite Fenpropimorph Acid in Soils, to Support the Application for New Registration of Wolsin® FL 35 Antisapstain containing the active ingredients, 5.4% Fenpropimorph, 2.7% Propi conazole and 9% Boric acid, EPA File Symbol 71406

- U. D333168

Gowda, S. November 8, 2006e. Review of the study, Leaching Behaviour of Wolsin FL

- 35 Treated Wood in UC 3, to Support the Application for New Registration of End Use Product, Wolsin® FL 35 Antisapstain containing the active ingredients, 5.4% Fenpropimorph, 2.7% Propiconazole and 9% Boric acid, EPA File Symbol 71406

- U. D333168

Gowda, S. November 8, 2006f. Review of the study, Leaching Behaviour of Wolsin FL

- 35 Treated Timber, to Support th e Application for New Registration of End Use Product, Wolsin® FL 35 Antisapstain containing the active ingredients, 5.4% Fenpropimorph, 2.7% Propiconazole and 9% Boric acid, EPA File Symbol 71406

- U. D333168

Gowda, S. June 26, 2007. Environmental Fate A ssessment of Fenpropimorph for New Chemical Registration. D333168Docket Number EPA

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Page 39 of 51 Hantzschel, D. (2006) Leaching Behavior of Wolsin Fl

- 35 Treated Wood Exposed in UC 3: Fenpropimorph . Project Number: Wolman230606, P1032/G, 1032/4/G. Unpublished study prepared by Dr. Wolm an Gmbh. 112 p. MRID 47010801

Maier, M. (2003) Leaching Behaviour of Wolsin FL

- 35 Treated Timber. Project Number: 08/2003. Unpublished study prepared by Dr. Wolman GMBH. 10 p. MRID 46074205

Rudel, H. 1988. Hydrolysis Studies on BAS 421 F at pH 3, 5, 7, and 9: Lab Project Number: 88/0443: BASF/88/0443: P86

- C011. Unpublished study prepared by Fraunhofer

- Institut fuer Umweltchemie und Oekotoxikologie. 48 p. MRID 45857216

Rudel, H

. September, 1989. Aerobic Metabolism Studies of BAS 421F. Fraunhofer

- Institut fur, Umweltchemie und Okotoxikogie, D

- 5948 Schmallenberg, Federal Republic of Germany. Study No.: P87

- C023. Sponsor: BASF Corporation. BASF Registration Document No.: 89/10140. MRID 45 857217).

Stockmaier, M.; Kreuzig, R.; Bahadir, M. (1996) Investigations on the Behaviour of Fenpropimorph and its Metabolite Fenpropimorph Acid in Soils. Pesticide Science 46:361

- 367. MRID 45857218Docket Number EPA

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Page 40 of 51 

# Appendix C Ecotoxicology Profile

Toxicity to Terrestrial Receptor s

Birds :
Two acute avian toxicity studies are available using technical fenpropimorph. Fenpropimorph is practically non

- toxic when administered orally or as a sub

- acute dietary
tr eatment to avian test species. Both studies are acceptable, and fulfill the guideline requirement for avian acute toxicity (MRIDs 45868901, 45857204)

.
Plants :
A Tier I vegetative vigor non

- target plant toxicity test was conducted on 10 vascular plants to determine if the maximum recommended label dosage is phytotoxic to plants. If greater than 25% injury or growth reduction occurs, the pesticide is considered phytotoxic and Tier II studies are triggered. In this Tier I study (MRID 46074306 )

, fenpropimorph was phytotoxic at greater than 25% to plants. The most sensitive monocot wa s corn, and the

m ost sensitive dicot was cabbage )

. Fenpropimorph Tier II dose response studies for seedling emergence and vegetative vigor are outstanding for the rooted aquatic macrophyte rice ( Oryza sativa ). No other terrestrial plant species are required to be tested by the Antimicrobial Division at the Tier II level. The Tier I vegetative vigor study is acceptable and fulfills the guideline requirement for 850.4150 (MRID 46074306 )

. 

## Toxicity to Aquatic Recept ors

Freshwater Fish :

Three acute freshwater fish t oxicity studies are available. Two studies, one using the Rainbow trout and one using the Bluegill sunfi sh, are technical grade tests. In both studies, the fenpropimorph was modera tely toxic to freshwater fish. In the third test, the end

- use formulation was used. In this study, the fenpropimorph, propiconazole, boric acid mixture was highly toxic to freshwater fish on an acute toxicity basis (LC 50 ≥ 0.74 mg/L, NOAEC = 0.10 mg/L). Th ese studies are acceptable and fulfill the guideline requirement for freshwater fish acute toxicity tests (MRIDs 45857205, 45857206, 46070203)

.
Estuarine/Marine Fish:

No studies are available for the technical

. However, the registrant has off

- labeled the u se of fenpropimorph in estuarine/marine habitats

, and therefore these data are not required.

Freshwater Invertebrates :
Two acute freshwater invertebrate toxicity tests are available using the Daphnia magna

. In the first, technical grade fenpropimorph was used. Fenpropimorph technical grade wasDocket Number EPA

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Page 41 of 51 slightly toxic. In the second study, the end

- use formulation was used. The fenpropimorph, propiconazole, boric acid mixture was highly toxic to freshwater aquatic invertebrates on an acute toxicity basis (LC 50 = 0.30 mg/L, NOAEC = 0.10 mg/L , MRIDs 45857207, 46074204 ).

Estuarine/Marine Invertebrates :
No studies are available for fenpropimorph technical. However, the registrant has off

labeled the use of fenpropimorph in estuarine/marine habitats

, and therefore these data are not required

. Chronic Aquatic Ecotoxicity Studies:

Freshwater Chronic Fish and Invertebrates :
Two chronic aquatic animal studies are available for technical grade fenpropimorph, a fish early life test using the Rainbow trout, and an inver tebrate life cycle study using Daphnia
magna

. The most sensitive species is the freshwater fish having a NOAE C <0.00016 mg/L (body length). Both studies are acceptable and fulfill the guideline requirements for chronic freshwater fish and invertebrates ( MR IDs 46074303, 46074305)

.
Estuarine/Marine Fish and Invertebrates :
No studies are available for fenpropimorph technical or end

- use product

. However, the registrant has off

- labeled the use of fenpropimorph in estuarine/marine habitats

, and therefore these data are not required.

Based on environmental fate data, fenpropimorph is either tightly bound to soil or converted to fenpropimorph acid. In laboratory studies, fenpropimorph acid (BF 421

- 2) was detected in sediment with a concentrati ons ranging from 6.2% to 9.1%. Fenpropimorph acid is not tightly bound to soil and has potential to move from th e treatment (or storage) site. Aquatic invertebrate acute toxicity tests are 48 hours in duration, fish studies are 96 hours in duration, and a lgal toxicity studies a re 96 to 120 days in duration. It is assumed that conversion from fenpropimorph parent to fenpropimorph acid will occur to some extent in aquatic toxicity tests.

Table C1 . Summary of Antisapstain fenpropimorph Ecotoxi city Studies

– 02/10/09

Study/Species MRID

Number Study Results Status of Study

Birds

Avian Acute Oral

– 96.6% 850.2100 /71

- 1 Bobwhite quail 45868901 LD 50 ≥ 2000 mg/Kg NOAEC = 1000 mg/kg CORE

- Practically

non

- toxic.

Avian Sub

- Acute Dietary

– 94.7% 45857204 LC 50 = 5000 mg/Kg CORE

- Practically

non

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Page 42 of 51 850.2200 /71

- 2 Mallard duck NOAEL = 1250 mg/Kg

Terrestrial Invertebrates

Acute Nontarget Insect

- Honey bee TGAI 95.7% 850.3020 acute oral

860.3030 acute contact 47125501 ORAL LC 50 ≥ 95.6 ug ai/bee NOAEC = 6.25 ug ai/bee CONTACT LC 50 ≥ 100 ug ai/bee NOAEC = 6.25 ug ai/bee Acceptable.

Aquatic Animals

Acute Freshwater Invert.

- 96.6% 850.1010 /72

- 2 Daphnia magna 45857207 EC 50 = 12.24 mg/L NOAEC = 1.0 mg/L CORE

– Slightly toxic.

Acute Freshwater Invert.

- Form. * 850.1010 /72

- 2 Daphnia magna 46074204 LC 50 = 0.30 mg/L NOAEC = 0.10 mg/L CORE

– Highly toxic

.

Acute Freshwater Invert.

- Fenpropimorph

. Acid

– 99.8% 850.1010/72

- 2 Daphnia magna 47425204 EC 50 ≥ 100 mg/L NOAEC ≥ 100 mg/L Supplemental

– Not repairable.

Acute Estuarine/Marine Invert. TGAI 850.1035 Mysid shrimp Waived

.

Acute Estuarine/Marine Invert. TGAI 850.1055 E. Oyster embryo larvae Waived

.

Acute Freshwater Fish

- 96.6% 850.1075 /72

- 1c Rainbow trout Oneorhyn chus mykiss 45857206 LC 50 = 5.15 mg/L NOAEC = >1.0 mg/L CORE

– Moderately toxic

.

Acute Freshwater Fish

- Form.* 850.1075 /72

- 1c Rainbow trout Oneorhyn chus mykiss 46074203 LC 50 ≥ 0.74 mg/L NOAEC = 0.10 mg/L CORE

– Highly toxic

.

Acute Freshwater Fish

- Fenpropimorph Acid 99.8% 850.1075 /72

- 1c Rainbow trout Oneorhyn chus mykiss 474252

- 02 LC 50 ≥ 100 mg/L NOAEC ≥ 100 mg/L Supplemental

– Not repairable.

Acute Freshwater Fish

- 96.6% 850.1075 /72

- 1a Bluegill sunfish Lepo mis macrochirus 45857205 LC 50 = 3.25 mg/L

NOAEC = 0.63 mg/L CORE

– Moderately toxic

.

Acute Estuarine/Marine Fish TGAI Waived

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Page 43 of 51 850.1075 Acute Sediment Freshwtr Inverts. Fen.Acid 850.1735 Waived

.

Acute Sediment Marine Inverts. Fen.Acid 850.1740 Waived

.

Acute Sediment Freshwtr Inverts. Fenpropimorph Acid

– 95.6% Chironomous riparius 850.1790 47425201 EC 50 ≥ 0.000125 mg/L

NOAEC ≥ 0.000125 mg/L Supplemental

– Not repairable.

Plants

Rooted Aquatic

- Rice 850.4225 /123

- 1 Oryza sativa Waived

.

Veg. Vigor

– Cabbage

Form.* Most sensitive dicot 850.4150 /122

- 1 Brassica oleracea 46074306 EC 25 > 25% effect Tier II data triggered. Supplemental Tier II data

.

Waived

.
Veg. Vigor

– Corn

Form* Most sen s itive monocot 850.4150 /122

- 1 Zea mays 46074306 EC 25 > 25% effect

Tier II data triggered. Supplemental Tier II

.

Waived

.
Floating macrophyte 850.4400 /123

- 2 Duckweed Lemna gibba Waived

.

Blue

- green cyanobacteria 850.5400 /123

- 2 Anabaena flos

- aquae Waived

.

Green algae

- 96.6% 850.5400 /123

- 2 Selenastrum capricornutum 45868903 EC 50 = 0.327 mg/L EC 10 = 0.005 mg/L Supplemental

.

Green algae

- Fenpropimorph Acid

- 99.8% 850.5400 /123

- 2 Selenastrum capricornutum 47425203 EC 50 ≥ 100 mg/L NOAEC= >25 mg/L Supplemental. Not repairable.

Freshwater diatom 850.5400 /123

- 2 Navicula pelliculosa Waived

.

Marine diatom 850.5400 /123

- 2 Skeletonema costatum Waived

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Page 44 of 51 Chronic Aquatic Tests

Fish Early Life

- 95.6% 850.1400 /72

- 4a Rainbow trout Oneorhyn chus mykiss 46074303 NOAEC ≤ 0.00016 mg/L for body length

NOAEC = 0.00016 mg/L

for body weight CORE

.

Aquatic Invertebrate Life Cycle

- 95.4% 850.1300 /72

- 4b Daphnia magna 46074305 NOAEC = 0.082 mg/L

EC50 = 0.41 mg/L CORE

.

* Formulation

– End

- use product (fenpropimorph=5.4%, propiconazole=2.7%, boric acid = 9.0%)

. References:

MRID 45857204: Avian Dietary LC50 Test Re. No. 108 406 (= Test Substance No. 87/133) in the Mallard Duck (

Anas platyrhynchos L.) January 1988. BASF AG Department of Agricultural Research and Development D

- 6703 Limburgerhof, Germany.

MRID 45857205: Fenpropimorph : Acute toxicity study on the blueg ill ( Lepomis macrochirus RAF) in a static system (96 hours). December 22, 1999. Department of Toxicology BASF Aktiengesellschaft D

- 67056 Ludwigshafen/Rhein, Germany. ID : 14F0235/995028

MRID 45857206: Fenpropimorph : Acute toxicity study on the rainbow tr out ( Oncorhynchus mykiss Walbaum 1792) in a static system (96 hours). December 2, 1999. Department of Toxicology BASF Aktiengesellschaft D

- 67056 Ludwigshafen/Rhein, Germany. ID : 121F0235/995026

MRID 45857207: Determination of the acute effect of BAS 42 1 F on the swimming ability of the water flea Daphnia magna STRAUS according to OECD 202 and GLP, EN 45001 and ISO 9002

. November, 1999. BASF Aktiengesellschaft Ecology and Environmental Analytics Laboratory of Ecology 67056 Ludwigshafen, Germany. Docume nt No.: 1999/11534

MRID 45868901: Fenpropimorph

- Avian Single Dose Oral LD 50 on the Bobwhite Quail ( Colinus virginianus ). February 3, 2000. Experimental Toxicology and Ecology BASF Aktiengesellschaft 67056 Ludwigshafen/Rhein, Germany. Report ID : 11W0235/99037

MRID 45868903: Effect of BAS 421 F on the Growth of the Green Alga Pseudokirchneriella subcapitata. February 29, 2000. BASF Aktiengesellschaft BASF Agricultural Center Limburgerhof Crop Protection Division Ecology and Environmental Anal ytics P.O. Box 12067114 Limburgerhof, Germany. Study No. 58022

MRID 46074203: Acute Toxicity of Wolsin FL

- 35 to Rainbow Trout ( Oncorhynchus mykiss ) in a 96

- hour Semi Static Test. April 2, 2003. Institut für Biologische Analytik und Consulting IBACON GmbH D

- 64380 Rossdorf, Germany. Report ID: 14643230

MRID 46074204: Acute Toxicity of Wolsin FL

- 35 to Daphnia magna in a 48

- hour Immobilization Test April 4, 2003. Institut für Biologische Analytik und Consulting IBACON GmbH D

- 64380 Rossdorf, Germany. R eport ID: 14642220Docket Number EPA

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Page 45 of 51 MRID 46074303: Early Life

- Stage Toxicity Test on the Rainbow Trout ( Oncorhynchus mykiss WALBAUM 1792) with Fenpropimorph. June, 1995. BASF Aktiengesellschaft Department of Toxicology D

- 67056 Ludwigshafen/Rhein, Germany. Doc. No: 95/1 0517

MRID 46074304: Chronic Effects of BAS 492 01 F on Juvenile Fish

- Leuciscus Idus L. “golden variety”

– under more realistic exposure conditions in small field microcosms. October 31, 2002 BASF Aktiengesellschaft Crop Protection Division D

- 67114 Limburgerhof, Germany. Report ID : 2002/1011545

MRID 46074305: Reproduction test of the test material Ro 14

- 3169/000 on Daphnia magna acc to OECD

- guideline 202 (Phase II). August 1989. NATEC

- Institut Behringstrasse 154 D

- 2000 Hamburg (FRG). Report ID: 89/10174

MRID 47425201: Effect of Fenpropimorph on the Sediment

- Dwelling Larvae of Chironomous riparius. September 1994. BASF Aktinogasellschaft, Ecology and Environmental Analytics, Postfatch 120 D

- 67114, Limburgerhof, FRG. Report ID : P94

- E027

MRID 47425204: Effect of Reg. No. 231346 on Daphnia magna STRAUS in a Static Acute Toxicity Test. February 1997. BASF Aktiengesellschaft, Ecology and Environmental Analytics, Postfach 120, D

- 67114 Limburgerhof, FRG. Report ID : 35504

MRID 47425203: Effect of BF 421

- 2 on the Growth of the Green Alga Pseudokirchneriella subcapitata. November, 1997. BASF Aktiengesellschaft, Ecology and Environmental Analytics, Postfach 120, D

- 67114 Limbugergerhof, FRG. Report ID : 43890

MRID 47425202: Acute Toxicity Study on the Rainbow Trout ( Oncorhynchus mykiss Walbaum 1792) w ith Static System (96 hours). December 1997. BASF Aktiengesellschaft, Department of Toxicology, D

- 67056 Lutwigshafen/Rhein, FRG. Report No. : 12F0411/975072

M RID 47675201 : Seedling Emergence, Tier II. September 18, 2008. Huntington Life Sciences Limited, Huntington Research Centre. R eport ID : DWM0002

MRID 47675201: Vegetative Vigour Tier II. June 17, 2008. Huntingdon Life Sciences Limited

, Huntingdon Research Centre. Report ID : DWM0003

MRID 47675202: Wolsin Fl

- 35: Phytotoxicity test with the freshwater duckweed ( Lemna gibba) , under s tatic c onditions. 23 October 2008. Springborn Smithers Laboratories (Europe), Seestrasse 21,Postfach, CH

- 9326 Horn, Switzerland. Report ID : 1111.001.410

MRID 47675203: Assessment of the algal toxicity, Tiers I and II (96h EC 50 ) of Wolsin FL

- 35 to T he marine alga Skeletonema costatum , the freshwater algae Selenastrum capricornutum and Anabaena flos aquae . November 5, 2008. Opus Plus Limited, Flotta, United Kingdom Report ID: 1051

- 27

USEPA. 2007. Ecological Risk a nd Fate Assessment for fe npropimorph (Wolsin® FL 35) New Chemical Wood Preservative Antisapstain Use

.
USEPA. 2009. Review of Studies and Ecotoxicity Data Waiver Requests for the Conditional Registration of the Antisapstain Use of fenpropimorph (Wolsin® FL 35)

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Page 46 of 51 

# Appendix D Screening Level Down

- the

Drain Analysis

Data for routes of dissipation and toxicity in WWTPs were not submitted

. However, data on the environmental fate of fenpropimorph in WWTPs are not anticipated to be required because fenpropimorph is not expect ed to be transported to WWTPs. The sole end

- use label states that wastes must be treated as hazardous waste and disposa l must be conducted according to label instructions, a state pesticide or environmental control agency, or by guidance from a h azardous waste representative. As a result, the agency does not plan to conduct a down

- the

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Page 47 of 51 

# Appendix E Pro duct Chemistry

Fenpropimorph product chemistry information is summarized in Table E1 (Source: MRIDS 44323904, 44323906, 44835201

, 45857201, 45857202, 45857203, 45857219, 4609750 1, 46097502 )

Table E1

– Product Chemistry of Fenpropimorph

Guideline No. Physical and Chemical

Properties Fenpropimorph

830.1550 Product identity and

composition Refer to Table 3

. 830.1600 Description of materials used

to produce the product Confidential Business Information (CBI)

.

830.1620 Description of production

process CBI

.

830.1650 Description of Formulation

Process CBI

.

830.1670 Discussion of Formation of

Impurities CBI

.

830.1700 Preliminary analysis CBI

. 830.1750 Certified limits CBI

. 830.1800 Enforcement analytical

method Capillary gas chromatography

. 830.1900 Submittal of samples CBI

. 830.6302 Color Colorless liquid

. 830.6303 Physical State Liquid. 830.6304 Odor Faint aromatic odor

.

830.6313 Stability to normal and

elevated temperature, metals/metal ions Stable to normal (25C) and elevated temperatures (54C) over the time interval of 14 days. Stable to metal and metal ions (aluminum, aluminum acetate, iron filings, and iron (II) acetate) at normal and elevated temperatures over the time interval of 14 days . Stable to light. 830.6314 Oxidation/Reduction Not oxidizing. No ox idizing properties

. 830.6315 Flammability Not flammable

. Flash point: 157oC

. 830.6316 Explodability Not explodable

. 830.6320 Corrosion Characteristic Not reported

. 830.7000 pH at 20C 8.6 at 1% in CIPAC water. 8.2 at 1% in de

- ionized water

. 830.7050 UV/Visible Absorption Photolytically stable in artificial sunlight (≥290 nm) for up to 30 days at pH 5 and 25 o C. 830.7100 Viscosity at 20C 229 mPa·s

. 830.7200 Melting point Liquid at STP

. 830.7220 Boiling point >300 o C

. 830.7300 Density 0.933 g/cm 3

. 830.7370 Dissociation Constant pK a : 6.98 (20oC); pK b 7.02 @ 20oC and 7.19 at 25oC

.Docket Number EPA

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Page 48 of 51 Guideline No. Physical and Chemical

Properties Fenpropimorph

830.7550 Partition coefficient ( n

octanol/water) 2.6 (22 o C, pH 5) 4.1 (22 o C. pH 7) 4.4 (22 oC, pH 9)

830.7840 Solubility in water pH 7: 4.32 mg/L at 20oC; pH 9

- 11: 3.53 mg/L at 20oC

.

830.7860 Solubility in organic solvents

(g/100 ml) Acetone 760.35 Ethyl Acetate 777.95 Toluene 764.60 Dichloromethane(DCM) 774.20

n

- Heptane 725.35 CAN or ACN 772.70 Methanol 789.15 Iso

- propanol 816.70 Octanol 770.50 Olive oil 778.90

830.7950 Vapor pressure (mm Hg) 3.5 x 10

- 5 at 20oC; 6.5 x 10

- 5 at 25 oC

.

Product Chemistry References

MRID 44323904. Kastel, R. (1994) Physical and Chemical Properties Report for Fenpropimorph...TGAI: Lab Project Number: 94/10392: PCF 01296. Unpublished study prepared by BASF Aktiengesellschaft. 9 p. {OPPTS 830.6313, 830.7300, 830.7000, 830.7220, 830.6315, 830.7100, 830.6302, 830.6303, 830.6304}

.
MRID 44323906. Bross, M. (1992) Determination of Fenpropimorph in Technical Fenpropimorph by Capillary GC: Analytic al Method CP No. 149/1: Lab Project Number: 92/11989. Unpublished study prepared by BASF Aktiengesellschaft. 9 p. {OPPTS 830.1800}

.
MRID 44835201. Cannan, T. (1998) BAS 421..F: Stability to Normal and Elevated Temperatures, Metals, and Metal Ions: Lab Pro ject Number: 98118: FR9864: 98/5182. Unpublished study prepared by BASF Corporation. 13 p. {OPPTS 830.1630}

.
MRID 45857201

. Redeker, D. (1998) Water Solubility of Fenpropimorph in the Neutral Range and at pH 9

- 11: Lab Project Number: 88/11302: BASF/88/11302: BASF 88/10154. Unpublished study prepared by BASF Aktiengesellschaft. 32 p

MRID 46097501. Redeker (1992) Determination of the Solubility of Fenpropimorph in Organic Solvents at 20 Degrees C. Project Number: PCP01861, 3348, 92/11596. Unpubli shed study prepared by BASF Ag Research Station (Basf Aktiengesellschaft). 16 p.

MRID 46097502. Kastel, R. (1994) Physical and Chemical Properties Report for Fenpropimorph. Project Number: 94/10395, BASF/94/10395, PCF/01295. Unpublished study prepared by BASF Ag Research Station (Basf Aktiengesellscaft). 11 p.Docket Number EPA

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Page 49 of 51 MRID 45857202. Redeker, D. (1998) Determination of the pKb Value of Fenpropimorph in Water: Lab Project Number: 88/11671: BASF/88/11671: 2541. Unpublished study prepared by BASF Aktiengesellschaft. 21 p.

MRID 45857203. Kastel, R. (1994) Physical and Chemical Properties Report for Fenpropimorph. Project Number: 94/10395, BASF/94/10395, PCF/01295. Unpublished study prepared by BASF Ag Research Station (Basf Aktiengesellscaft). 11 p.Docket Number EPA

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Page 50 of 51 

# Appendix F Comments Received Concerning the Preliminary Work Plan

On September 24, 2014, EPA opened a 60

- day public comment period on the preliminary work plan (PWP) for the registration review of fenpropimorph. The comment period ended on November 24, 2014. During the public comment period the agency received two submis sions related to the fenpropimorph PWP. Table F 1 below lists the submitters.

Table F 1. Submitters of Comments on the “Fenpropimorph Preliminary Workplan”

BASF Corporation

FIFRA Endangered Species Task Force (FESTF)



### FESTF

Comment

- The FIFRA Endangered Species Task Force (FESTF) submitted a comment noting that it has data that will assist the a gency in conducting an endangered species risk assessment for fenpropimorph.

EPA Response

- The a gency thanks FESTF for its comment and will consider this informat ion as it conducts the registration review and makes its registration review decisions.

BASF

850.3020

- Honey bee acute contact toxicity, TGAI

Comment

- BASF appreciates the importance of quantifying potential risks to beneficial insects, particularly pollinators. BASF has previously submitted a honey bee acute oral and contact toxicity study using fenpropimorph TGAI (MRID 47125501). The results from that study indicate that fenpropimorph is practically non

- toxic to adult honey bees, with oral 48

- hr LD50 value of ˃ 95 μg ai/bee and contact 48

- hr LD50 value of ˃100 μg ai/bee. A dose of 100 μg ai/bee is typically used as a limit dose in such studies. The stud y submitted in 2007 was classified as Acceptable (Supplemental) by EPA due to minor test guideline deviations related to cage temperature and relative humidity. The study controls confirm that those minor deviations did not influence the study outcome and conducting a new study would likely yield similar results. Moreover, the current OCSPP 850.3020 guideline says, “... it is unlikely a study will be rejected when there are slight variations from guideline environmental conditions and study design unless the control organisms are significantly affected...” The registered end use product containing fenpropimorph (5.4% ai) is an industrial wood preservative used to protect freshly cut lumber and woodDocket Number EPA

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Page 51 of 51 products during drying, storage and transport. It is applied to the surface of the exposed wood and provides temporary protection against sapstain, mold and decay. This surface treatment is physically removed during processing of the lumber, wood and wood products. Additionally, label directions specify, “Lumber treate d with Sinesto® PFB must be stored under cover, indoors, or at least 100 feet from any pond, lake, stream, wetland or river ...Treated lumber stored within 100 feet of a pond, lake, stream, wetland or river must be either covered with plastic or surrounded b y a berm...” Therefore, bee exposure to treated lumber (and wood products) is highly unlikely. Due to the low toxicity of fenpropimorph to honey bees and the limited exposure potential, BASF requests a waiver from additional honey bee testing.

EPA Response

- The agency thanks BASF for their comment. The agency has reviewed the data, and agrees that the submitted study is acceptable. Thus, the agency has removed the honeybee acute contact study from the anticipated data needs for fenpropimorph’s registration re view.

875.1700

- Applicator Exposure Product Use Information, TEP

Comment

- “ BASF was unable to find guideline 875.1700 Applicator Exposure: Product Use Information among the OCSPP Harmonized Test Guidelines on the EPA’s website. Therefore, BASF requests that a copy of this guideline be provided for our review ”

.
EPA R esponse - The current product use guideline is not yet available as a final draft to the public. Draft guidelines on Product Use Information are available from the Science Advisory Panel (1998) on the web and can be found (under guideline 875.2700

- this guideline is for Post A pplication E xposure ) at http://www.epa.gov/sci poly/sap/meetings/1998/march/contents.htm

. The agency has a more recent description of product use template available on the web which includes the general information to complete a product use study for handler and post application
exposures . This information can be found at: http://www2.epa.gov/pesticide

registration/study

- profile

- templates#toxicology under the 875 Use Pattern (Occupational and Resid ential Exposure Test Guidelines) u nder the Study Profile Template section

, please refer to the Use Pattern/ Exposure Scenarios document

. Since fenpropimorph is used as a wood preservative, the agency is interested in the non

- pressure treatment of wood (spray/ dip tank application methods) and the A merican W ood P rotection A ssociation (AWPA) retention and description of the wood use (e.g., decks, play sets

, fence posts , etc.)

. For handler activities

, the agency anticipates needing a general description of equipment, procedures, durations, and frequencies for worker tasks.