### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



### MEMORANDUM

Date: 25

- FEB-2015 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION



### SUBJECT: Propoxycarbazone-sodium. Human Health Assessment Seeping Document and Preliminary Human Health Risk Assessment in Support of Registration Review.

PC Code: 122 019 

### Decision No.: 496089 

### Petition No.: N/ A 

### Risk Assessment Type: Single Chemical/Aggregate 

### TXRNo.: NA 

### MRIDNo.: NA 

### DP Barcode: 0423232 

### Registration No.: N/ A Regulatory Action: Regi s tration Review Risk Assess ment 

### Case No.: 7264 

### CAS No.: 181274-15-7 (sodium salt); 145026-81-9 (acid) 40 

### CFR: § 180.600



### FROM: Sarah J. Levy,

# Chemist~() 1/}' /

- · ·

# .., Kelly M. Lowe, Environmental

# Stie~**YZ:~/ --**  Monique M. Perron,

## Sc.D~~xi**log~** 

# '--uru-

. :.U\fi-/-- 

### Jaclyn Pyne, Biologis t**(/~** 

### Risk Assessment Branch (RA 1) Health Effects Division (HED; 7509P)

THRU:

TO: La ta Venkateshwara!Avivah Jakob Pesticide Re-evaluation Division (PRD; 7508P)

As part of Registration Review, PRD of the Office of Pes t icide Programs (OPP) has reques ted that HED evaluate the hazard and exposure data and conduct occupational and residential
exposure asse ssmen ts , as needed, to estimate the risk to human health that will result from the currently registered uses of pesticides. This memorandum serves as HED 's seeping document AND preliminary human health risk assessment of the dietary, occupational and residential
exposure, and aggregate risk from the registered uses of propoxycarbazone-sodi u m (methyl 2- [[[( 4,5

- dihydro-4-methyl -5 -oxo -3-p ropoxy -1 H-1 

### ,2,4-triazol-1-yl)carbonyl]amino ]sulfonyl] benzoate so dium salt). The most recent human health risk assessment was performed in 2008, and was for the use of propoxycarbazone-sodium on pasture and rangeland grasses (Memo, S. Levy et al., 1 0-DEC-2008; D34851 0). T h e following risk assessment updates ha ve been made:

Page 1 of29Propoxycarbazone-sodium Human Health Risk Assessment 0423232



### • Chronic dietary (food+ drinking water) exposure assessment to reflect revised estimated drinking water concentrations (E DW Cs) using the Dietary Exposure Evaluat ion ModelFood Consumption Intake Database (DEEM-FCID, ver. 3.16) which incorporates consumption data from USDA NHAN ES/WWE IA (2003-2008);

• Quantitative spray-drift exposure/risk assessment; and

• Updates to HED's exposure policies/data, along with policy changes for body weight assumptions.

A summary ofthe findings and an assessment of human risk resulting from the registered uses of propoxycarbazone-sodium are provided in this document. The risk assessment was provided by Sarah Levy (RAB 1 ), the dietary risk assessment and residue chemistry review were provided by Jackie Pyne (on detail to RAB 1 ), the occupational/residential exposur e assessment was provided by Kelly Lowe (RAB 1 ), the hazard characterization was provided by Monique Perron (RAB 1 ), and the drinking water assessmen t was provided by James Lin of the Environmental Fate and Effects Division (EFED).

Page 2 of29Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 3 of 29 

### Table of Contents

1.0 Executive Summary

................................ ................................ ................................ ................................ ....... 4 2.0 Recommendations

................................ ................................ ................................ ................................ .......... 6 3.0 Ingredient Profile

................................ ................................ ................................ ................................ ........... 8 4.0 Hazard Identification/Toxicology

................................ ................................ ................................ .................. 9 5. 0 Dietary Exposure and Risk Assessment

................................ ................................ ................................ ....... 12 6.0 Residential (Non

- Occupational) Exposure and Risk Assessment

................................ ................................ 14 7.0 Aggregate Expos ure and Risk Assessment

................................ ................................ ................................ .. 16 8.0 Cumulative Exposure/Risk Characterization

................................ ................................ ............................... 16 9.0 Occupational Exposure

................................ ................................ ................................ ................................ 17 10.0 Public Health and Pesticide Epidemiology Data

................................ ................................ ......................... 19 11.0 References

................................ ................................ ................................ ................................ .................... 19 Attachment 1: Chemical Identity Tables.

................................ ................................ ................................ ............... 20 Attachment 2: Propoxycarbazone

- Sodium Acute, Subchronic, and Chronic Toxicity Profile.

.............................. 22 Attachm ent 3: Registered Propoxycarbazone End Use Products and Use Patterns.

................................ ............... 26 Attachment 4: Chronic Dietary Exposure Files.

................................ ................................ ................................ ..... 27 Atta chment 5: Propoxycarbazone

- sodium IRLS Sheet.

................................ ................................ .......................... 29Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 4 of 29 

### 1.0 Executive Summary

Propoxycarbazone

- sodium is a selective postemergence herbicide belonging to the sulfonamide class of herbicides. There are currently three end

- use products containing propoxycarbazone

sodium that are registered by Bayer CropScience. It is formulated as a dry flowable ( DF ), and is

c urrently registered for use in control of certain grasses and broadleaf weeds in wheat , triticale, and pastureland/range land

. There are currently no registered special local needs ( SLN ) or Section 18 Emergency Exemptions, and no pe nding PRIA actions for propoxycarbazone

- sodium

. The most recent quantitative human health risk assessment was performed in 20 0 8 in conjunction with the request for the use of propoxycarbazone

- sodium on pasture and rangeland
grasses ( Memo, S. Levy et al.

, 10

- DEC

- 200 8 ; D 348510 ).

HED has ev aluated the status of the human health risk assessments for propoxycarbazone

sodium to determine whether suf ficient data are available and whether any updates are needed to support Registration Review. Since the last human health risk assessment for propoxycarbazone

- sodium

, no new data have been submitted , and no changes have been made to the selected endpoints , toxicological points of departure ( PODs)

, or recommended tolerances

. This doc ument incorporates changes made to HED policies, revised exposure and risk estimates, and a quantitative spray

- drift exposure /risk assessment

.
Hazard Assessment and Dose Respo nse Assessment : The toxicology database for propoxycarbazone

- sodium is complete to support Registration Review except for the subchronic inhalation study that is required in accordance with the current 40 CFR Part 158 Toxicology Data Requirements. Howeve r, t he Hazard and Science Policy Council (HASPOC) concluded

, based on a weight

- of

- evidence approach

, that this study is not required at this time (U. Habiba; 18

- NOV

- 201 4; TXR#0057073). The endpoints, PODs , and safety factors (SFs) for propoxycarbazone

- sod ium from the most

- recent human health risk assessment are considered protective of all effects seen in the database; however, updates were made to reflect current HED policy. For all exposure scenarios, a 100

- fold uncertainty factor (UF) (10X for interspe cies extrapolation, 10X for intraspecies variation, and 1X for Food Quality Protection Act (FQPA) SF when applicable) was applied.

Residue Chemistry and Dietary Risk Estimates (Food + Drinking Water ): The residue chemistry database is adequate to suppor t current Registration Review data requirements. Adequate metabolism (crops, livestock, and rotational crops), storage stability, magnitude of the residue, and processing data are available to support the registered uses. Adequate methods are available f or enforcement of the currently established tolerances.

The dietary exposure database is adequate to support current Registration Review requirements. The chronic dietary exposure assessment was updated to reflect revised EDWCs using the Dietary Exposu re Evaluation Model

- Food Consumption Intake Database (DEEM

- FCID, ver. 3.16) which incorporates consumption data from USDA NHANES/WWEIA ( 2003

- 2008) . The unrefined [tolerance

- level residues, 100% crop treated (CT), DEEM (ver. 7.81) default processing fact ors, and modeled drinking water estimates] chronic dietary (food + drinking water) exposure estimates are below HED’s level of concern [ LOC; < 100% of the chronic population

- adjusted dose ( cPAD) ] for the general U.S. population and all population subgroups (<1% of the cPAD). An acute dietary (food + drinking water) exposure and risk assessment was
not conducted for propoxycarbazone

- sodium because an endpoint of concern attributable to a single oral dose was not selected for any population subgroup (includin g infants and children).Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 5 of 29 

### Propoxycarbazone

- sodium was classified as “not likely to be carcinogenic to humans”; therefore, a cancer dietary assessment was not performed.

Re sidential (Non

- Occupational) Exposure and Risk Assessment: There are no proposed or current registrations for products containing propoxycarbazone

- sodium that allow residential use. Therefore, residential handler and conventional residential post

- application ex posure assessments were not conducted to support Registration Review. A quan titative spray

- drift
assessment was conducted. Risk estimates from groundboom and aerial applications are not of

concern at the field edge for all scenarios considered.

Aggregate

- Risk Estimates: There is sufficient information available to assess ag gr egate exposure. In accordance with FQPA, HED must consider and aggregate pesticide exposures and risks from three major sources: food, drinking wa ter, and residential exposures. An acute aggregate risk assessment was not performed because an endpoint of concern attributable to a single oral dose was not selected for any population subgroup (including infants and children). Short

- and intermediate

- term aggregate risk assessments were not performed because there are no registered residential non

- food uses. A cancer aggregate risk assessment was not performed because propoxycarbazone

- sodium is classified as “not likely to be carcinogenic to humans.” The chron ic aggregate assessment consists of only of dietary sources; therefore, the exposure estimates prov ided in the dietary exposure analyses represent chronic aggregate exposure. Therefore, the chronic aggregate (food + drinking water) propoxycarbazone

- sodium risk
est imates do not exceed HED ’s LOC

. Occupational Exposure and Risk Assessment: The occupati onal exposure database is adequate to support the Registration Review process for propoxycarbazone

- sodium . There is the potential for occupational exposure from the registered uses of propoxycarbazone

- sodium

. These uses have been assessed using the most up

- to

- date exposure policies and data available. Since no dermal hazard was identified, a quantitative dermal assessment was not conducted for the occupational uses of propoxycarbazone

- sodium . The occupational handler exposure and risk estimates indicate that the short

- and intermediate

- term inhalation margins of exposure (MOEs) do not exceed HED ’s LOC (i.e., MOE > the LOC of 100).

Occupational post

- application dermal exposure and risk estimates were not quantitatively assessed since a dermal hazard was not identified. Based on the Agency's current practices, a quantitative non

- cancer occupational post

- application inhalation exposure assessmen t was not performed for propoxycarbazone

- sodium at this time. If new policies or procedures are put into place, then the Agency may revisit the need for a quantitative occupational post

- application inhalation exposure assessment for propoxycarbazone

- sodium

.

Environmental Justice Considerations: Potential areas of environmental justice concerns, to the extent poss ible , were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, “Federal Actions to Address Environmental Justice in Minority Populations and Low

- Income Populations.”

Review of Human Research: This risk assessme nt relies in part on data from studies in which adult human subjects were intentionally exposed to a pesticide or other chemical. These data, which include studies from the Pesticide Handlers Exposure Database (PHED) 1.1 and the Agricultural Handler Expos u re Task Force (AHETF) database are (1) subject to ethics review pursuant to 40 CFR 2 6, (2) have received that review, and (3) are compliant with applicable ethics requirements. For certain studies, the ethics review may have included review by the Human Studies Review Board.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 6 of 2 9 

### Descriptions of data sources, as well as guidance on their use, can be found at the following Agency websites: http://www.epa.gov/pesticides/science/han dler

- exposure

- data.html and http://www.epa.gov/pesticides/science/post

- app

- exposure

- data.html

.

2.0 Recommendations

HED has examined the toxicology and residue chemistry databases for propoxycarbazone

sodium . There are no residue chemistry, occupational /residential , or toxicology data deficiencies that would preclude the continuation of all registered uses and permanent tolerances for the combined residues of propoxycarb azone

- sodium and its metabolite Pr

- 2

- OH [methyl 2

- [[[(4,5

- dihydro

- 3

- (2

- hydroxypropoxy)

- 4

- methyl

- 5

- oxo

- 1 H

- 1,2,4

- triazol

- 1

- l)carbonyl]amino]sulfonyl] benzoate] as outlined in Table 2.2.3 .1.

2.1 Data Deficiencies

There are no data deficiencies for propo xycarbazone

- sodium

.

2.2 Tolerance Considerations

2.2.1 Enforcement Analytical Method

For purposes of Registration Revi ew, an a dequate method is available for enforcing the current grass, wheat, and livestock tolerances. The liquid chromatography/mass s pectroscopy/mass spectroscopy (LC/MS/MS) enforcement method (Bayer Method No. 108817) is available for enforcing tolerances for residues of propoxycarbazone

- sodium and its Pr

- 2

- OH metabolite [methyl 2

- [[[(4,5

- dihydro

- 3

- (2

- hydroxypropoxy)

- 4

- methyl

- 5

- oxo

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]amino]sulfonyl]benzoate], in/on wheat and livestock commodities. Although the method has been deemed acceptable, HED previously asked for clarification concerning the instructions to clearly state th at propoxycarbazone

- sodium as the free acid is the compound to be used for preparation of standard and fortification solutions . Furthermore, the petitioner defined MKH 6561 as both “propoxycarbazone

- sodium” and “propoxycarbazone (acid)” (Memo, S. Levy, 25

- SEP

- 2013; D412002). HED r equests that these clarifications still be submitted.

T he Pr

- 2

- OH standard does not expire until 07

- DEC

- 1019 ; however , the EPA National Pesticide Standard Repository has requested that the registrant send ~ 1 gram to the R epository as soon as possible, as the current amount of standard is low (electronic communication, T. Cole to S. Levy, 26

- JAN

- 2015).

Food and Drug Administration (FDA) multiresidue method (MRM) testing data have been submitted for propoxycarbazone

- sodium (as the free acid) and its metabol ite Pr

- 2

- OH

. Propoxycarbazone

- sodium and its metabolite Pr

- 2

- OH were not adequately recovered from any of the MRMs (Memo, G. Kramer, 22

- SEP

- 2003; DP#: 293677). Therefore, the MRM are not adequate for enforcement of tolerances for residues of propoxycarba zone

- sodium and its Pr

- 2

- OH metabolite.

2.2.2 International Harmonization

With the exception of wheat grain, there are no Canadian, Mexican, or Codex maximum residue limits (MRLs) established for residues of propoxycarbazone

- sodium

. The Canadian MRL for residues of propoxycarbazone

- sodium and its metabolite in/on wheat, grain ( 0.02 ppm ) , isPropoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 7 of 29 

### equivalent to the U.S. tolerance expression and level

. Therefore, h armonization is not an issue at this time. For a summary of U.S. tolerances

, refer to Attachment 5

.

2.2.3 Tolerance Recommendations

Tolerances for propoxycarbazone

- sodium are currently established for the combined residues of propoxycarbazone

- sodium and its Pr

- 2

- OH metabolite [methyl 2

- [[[(4,5

- dihydro

- 3

- (2

- hydroxypropoxy)

- 4

- methyl

- 5

- oxo

- 1 H

- 1,2,4

- tri azol

- 1

- yl)carbonyl]amino]sulfonyl]benzoate], expressed as parent, in/on wheat, forage at 17 ppm, wheat, grain at 0.02 ppm, wheat, hay at 0.15 ppm and wheat, straw at 0.05 ppm [40 CFR §180.600(a)(1)]. In addition, tolerances are currently established for r esidues of propoxycarbazone per se in selected livestock commodities at 0.03

- 0.3 ppm [40 CFR §180.600(a)(2)]. There are currently no Section 18 Emergency Exemptions, tolerances with regional registrations, or tolerances for indirect/inadvertent residues i n rotational crops.

The tolerance expression for propoxycarbazone

- sodium has been reviewed and should be updated as follows

, based on HED’s Interim Guidance on Tolerance Expressions (S. Knizner, 27

- MAY

- 200 9).

40 CFR §180.600(a)(1) Tolerances are establ ished for residues of the herbicide propoxycarbazone

- sodium , including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only the sum of propo xycarbazone

- sodium ( methyl 2

- [[[(4,5

- dihydro

- 4

- methyl

- 5

- oxo

3

- propoxy

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]amino]sulfonyl]benzoate sodium salt ) and its metabolite methyl 2

- [[[(4,5

- dihydro

- 3

- (2

- hydroxypropoxy)

- 4

- methyl

- 5

- oxo

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]amino]s ulfonyl]benzoate , calculated as the stoichiometric equivalent of propoxycarbazone , in or on the commodity.

40 CFR §180.600(a)( 2 ) Tolerances are established for residues of the herbicide propoxycarbazone

- sodium, including its metabolites and degradates, in or on the commodities in the table below. Compliance with the tolerance levels specified below is to be determined by measuring only propoxycarbazone

- sodium (methyl 2

- [[[(4,5

- dihydro

- 4

- methyl

- 5

- oxo

- 3

- propoxy

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]amino]sulfonyl] benzoate sodium salt), in or on the commodity.

The residue chemistry database supports the currently established tolerances as listed in 40 CFR §180. 600

. Table 2.2. 3 .1 is a sum mary of the established and HED

- recommended tolerances for residues of propoxy carbazone

- sodium

.

Table 2.2.3 .1. Tolerance Summary for Propoxycarbazone

- Sodium (40 CFR §180. 600 ).
Commodity Established Tolerance (ppm) HED

- Recommended Tolerance (ppm) Comments

40 CFR §180. 600 (a)(1) Grass, forage 20 Grass, hay 25 Wheat, forage 17 Wheat, grain 0.02 Wheat, hay 0.15 Wheat, straw 0.05 40 CFR §180. 600 (a)(2 )Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 8 of 29 Table 2.2.3 .1. Tolerance Summary for Propoxycarbazone

- Sodium (40 CFR §180. 600 ).
Commodity Established Tolerance (ppm) HED

- Recommended Tolerance (ppm) Comments

Cattle, meat 0.05

Correct number of significant figures to be consistent with HED policy. Cattle, meat byproducts 0.3 0.30 Goat, meat 0.05 Goat, meat byproduc ts 0.3 0.30 Horse, meat 0.05 Horse, meat byproducts 0.3 0.30
Milk 0.03 Sheep, meat 0.05 Sheep, meat byproducts 0.3 0.30



### 2.3 Label Recommendations

No revision s to the registered label s are required to support Registration Review.

3.0 Ingre dient Profile

3.1 Chemical Identity and Physical/Chemical Proper ties

The chemical structure and nomenclature of propoxycarbazone

- sodium and its metabolite Pr

- 2

- OH

, and a detailed description of the physicochem ical properties of propoxycarbazone

- sodium

ar e provided in Attachment 1

.

3.2 Use Pattern

Propoxycarbazone

- sodium is registered as a DF formulation for control of certain grasses and broadleaf weeds in wheat and pastureland/rangeland. T he maximum application rate for all uses is 0.05 lb a

. i

. /A, and both broadcast and spot applications (in pastures/rangeland only) can be made using aerial, groundboom

, and handheld equipment. Applications to wheat and triticale can be made pre

- plant, pre

- emergence, or post

- emergence, while applications to rangelan d/pastureland is to only be made post

- emergence. A s ummary of th e registered uses are included in Attachment 3

.

3.3 Anticipated Exposure Pathways

Based on the regist ered application scenarios, dietary exposure is an anticipated exposure path way as resi dues of propoxycarbazone

- sodium may be found in/on crops , livestock, and drinking water. Although t here are no registered r esidential uses of propoxycarbazone

- sodium

, there is a potential for spray drift that may result in exposure s in residential and non

- occupational settings. In an occupational setting, applicators may be exposed while handling the pesticide prior to application, as well as during application. There is also potential for post

- application exposure for workers re

- entering treated sites. This risk assessment considers all of the aforementioned exposure pathways based on the existing uses of propoxycarbazone

- sodium

.

3.4 Consideration of Environmental Justice

Potential areas of environmental justice concerns, to the extent possible, were considered in this human health risk assessment, in accordance with U.S. Executive Order 12898, "Federal ActionsPropoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 9 of 29 

### to Address Environmental Justice in Minority Populations and Low

- Income Populations," (http://epa.gov/compliance/ej/resources/policy/exec_orde r_12898.pdf). As a part of every pesticide risk assessment, OPP considers a large variety of consumer subgroups according to well

- established procedures. In line with OPP policy, HED estimates risks to population subgroups from pesticide exposures that a re based on patterns of that subgroup’s food and water consumption, and activities in and around the home that involve pesticide use in a residential setting. Extensive data on food consumption patterns are compiled by the USDA ’s NHANES/WWEIA and are used in pesticide risk assessments for all registered food uses of a pesticide. These data are analyzed and categorized by subgroups based on age and ethnic group. Additionally, OPP is able to assess dietary exposure to smaller, specialized subgroups and
exp osure assessments are performed when conditions or circumstances warrant. Whenever appropriate, non

- dietary exposures based on home use of pesticide products and associated risks for adult applicators and for toddlers, youths, and adults entering or playi ng on treated areas post

- application are evaluated. Further considerations are currently in development as OPP has committed resources and expertise to the development of specialized software and models that consider exposure to bystanders and farm worker s as well as lifestyle and traditional dietary patterns among specific subgroups.

4 .0 Hazard Identification/Toxicology

The main target organ of propoxycarbazone

- sodium appears to be the gastrointestinal tract with irritation obse rved in the rat subchroni c oral, rabbit developmental, and two

- generation reproduction toxicity studies at relatively high doses (≥300 mg/kg/day). In the combined chronic/carcinogenicity toxicity study in rats, histopathological changes in the kidney and increased urinary pH were observed at approximately 500 mg/kg/day. In mice, effects from subchronic and chronic exposure were limited to body weight decrements at doses near or above the limit dose (1000 mg/kg/day). No effects were seen in dogs.

There was no evidence of incr eased quantitative or qualitative susceptibility to offspring. In the rabbit developmental toxicity study, developmental toxicity (decreased fetal weights and increased pre

- and post

- implantation loss) was observed at the limit dose (1000 mg/kg/day), whil e maternal toxicity (gastrointestinal toxicity and body weight decrements) was seen at 500 mg/kg/day. In the rat two

- generation reproduction toxicity study, offspring toxicity (increased post

- implantation loss and decreased litter size) was only noted at doses greater than the limit dose (>1200 mg/kg/day). Parental toxicity in this study was evidenced by microscopic lesions in the stomach at the mid

- dose (~300 mg/kg/day). In the rat developmental toxicity study, no maternal or developmental effects were seen up to the limit dose (1000 mg/kg/day).

Propoxycarbazone

- sodium was classified as having low acute toxicity via the oral, dermal, and inhalation routes (Toxicity Category IV). It is not an eye irritant, dermal irritant, or dermal sensitizer. No toxi city was observed at the limit dose in a 28

- day dermal toxicity study in rats.

Propoxycarbazone

- sodium is classified as “not likely to be carcinogenic to humans” based on lack of evidence of carcinogenicity in mice and rats and negative findings in mutage nicity
assays.

The toxicology database for propoxycarbazone

- sodium is complete for Registration Review except for the subchronic inhalation study that is required in accordance with the current 40 CFR Part 158 Toxicology Data Requirements . However, t he H ASPOC concluded

, based on a weight

of

- evidence approach

, that this study is not required at this time (U. Habiba; 18

- NOV

- 2014;Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 10 of 29 

### TXR#0057073). The endpoints, PODs , and SFs for propoxycarbazone

- sodium from the most

recent human health risk assessment ( Memo, S. Levy et al. , 10

- DEC

- 2008; D348510 ) are considered protective of all effects seen in the database; however, the following updates were made to reflect current HED policy : o ne endpoint was selected to assess bo th short

- and intermediate

- term inhalation e xposures , and endpoints for long

- term dermal and inhalation exposures are not needed because long

- term exposures are not expected based on the use pattern for propoxycarbazone

- sodium. For all exposure scenarios, a 100

- fold UF (10X for interspecies extrapo lation, 10X for intraspecies variation, and 1X for FQPA SF when applicable) was applied.

Table 4.0. 1. Summary of Toxicological Doses and Endpoints for Propoxycarbazone

- Sodium for Use in Dietary and Non

- Occupational Human

- Health Risk Assessments. Expos ure/ Scenario POD UFs/ FQPA SF RfD, PAD, LOC for

Risk Assessment Study and Toxicological Effects

Acute Dietary (All populations) A dose and endpoint of concern attributable to a single dose was not observed.

Chronic Dietary (All Populations) NOAEL =

74. 8 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X Chronic Rfd =

0.748 mg/kg/day

cPAD = 0.748 mg/kg/day Two

- Generation Reproduction Study LOAEL = 297.1 mg/kg/day based on microscopic lesions of the stomach in parental male rats

.
Incidental Oral Short

- Term (1

- 30 days) and Intermediate

- Term (1

- 6 months) NOAEL =

74.8 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X Residential LOC for MOE = 100 Two

- Generation Reproduction

Study LOAEL = 297.1 mg/kg/day based on microscopic lesions of the stomach in parental male rats

.
Dermal Short

- Term (1

- 30 days) and Intermediate

- Term (1

- 6 months) No dermal assessment required. No adverse effects were seen up to the limit dose in the route

- specific

dermal toxicity study and there was no evidence of quantitative susceptibility. A dditionally, the gastrointestinal effects seen in oral studies would not be expected to occur following a dermal exposure.

Cancer (oral, dermal, inhalation) Classification: “not likely to be carcinogenic to humans

. ”

Point of departure (POD) = A data poi nt or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to determine risk associated with lower environmentally relevant human exposures. NOAEL =

no

- observed adverse

- effect level. LOAEL = lowest

- observed adverse

- effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). FQPA SF = FQPA Safety Factor. PAD = population

- adjusted dose (a = acute, c = chronic). RfD = reference dose. MOE = margin of exposure. LOC = level of concern.

Table 4.0.2 . Summary of Toxicological Doses and Endpoints for Propoxycarbazone

- Sodium for Use in Occupational Human

- Health Ri sk Assessments. Exposure/ Scenario POD UFs LOC for Risk Assessment Study and Toxicological Effects

Dermal Short

- Term (1

- 30 days) and Intermediate

- Term (1

- 6 months) No dermal assessment required. No adverse effects were seen up to the limit dose in the route

- specific

dermal toxicity study and there was no evidence of quantitative susceptibility. Additionally, the gastrointestinal effects seen in oral studies would not be expected to occur following a dermal exposure.

Inhalation Short

Term (1

- 30 days) and Intermediate

- term (1

- 6 months) NOAEL =

74.8 mg/kg/day UF A = 10X

UF H = 10X FQPA SF = 1X Occupational LOC for MOE = 100 Two

- Generation Reproduction

Study LOAEL = 297.1 mg/kg/day based on microscopic lesions of the stomach in parental male rats

.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 11 of 29 Table 4.0.2 . Summary of Toxicological Doses and Endpoints for Propoxycarbazone

- Sodium for Use in Occupational Human

- Health Ri sk Assessments. Exposure/ Scenario POD UFs LOC for Risk Assessment Study and Toxicological Effects

Cance r (oral, dermal, inhalation) Classification: “not likely to be carcinogenic to humans

. ”

Point of departure (POD) = A data point or an estimated point that is derived from observed dose

- response data and used to mark the beginning of extrapolation to det ermine risk associated with lower environmentally relevant human exposures. NOAEL =

no

- observed adverse

- effect level. LOAEL = lowest

- observed adverse

- effect level. UF = uncertainty factor. UF A = extrapolation from animal to human (interspecies). UF H = potential variation in sensitivity among members of the human population (intraspecies). MOE = margin of exposure. LOC = level of concern.



### 4.1 Endocrine Disruptor Screening Program

As required by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug, and Cosmetic Act (FFDCA) , EPA reviews numerous studies to assess potential adverse outcomes from exposure to chemicals. Collectively, 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 endocrine 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 acute tests and chronic studies that assess growth, developmental and reproductive effects in different taxonomic groups. As part of its reregistration decision for propoxycarbazone

- sodium, EPA reviewed these data an d selected the most sensitive endpoints for relevant risk assessment scenarios from the existing hazard database. However, as requi red by FFDCA section 408(p), propoxycarbazone

- sodium is subject to the endocrine screening part of the Endocrine Disruptor Sc reening Program (EDSP).

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

- tiered approach to making the statutorily re quired determinations. Tier 1 consists of a battery of 11 screening assays to identify the potential of a chemical substance to interact with the estrogen, androgen, or thyroid (E, A, or T) hormonal systems. Chemicals that go 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 E PA will determine which, if any, of the Tier 2 tests are necessary based on the available data. Tier 2 testing is designed to i dentify any adverse endocrine

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

- response relationship between the dos e 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 (a.i. ’ s) and 9 inert ingredients. A second list of chemicals identified for EDSP screening was published on June 1 4, 2013 1 

### and includes some pesticides scheduled for Registration Review and chemicals found in water

. Neither of these lists should be const rued as a list of known or likely endocrine disruptors.

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

- HQ

- OPPT

- 2009

- 0477

- 0074 for the final second list of chemicalsPropoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 12 of 29 

### For further information on the status of the EDSP, the pol icies and procedures, the lists of chemicals, future lists, the test guidelines and the Tier 1 screening battery, please visit our website. 2



### 5.0 Dietary Exposure and Risk Assessment

5.1 Residue Chemistry

Permanent tolerances are established for the comb ined residues of propoxycarbazone

- sodium and its Pr

- 2

- OH metabolite , expressed as parent, in/on a variety of crops, w ith tolerances ranging from 0.0 2 ppm to 25 ppm (40 CFR §180.600 (a)). In addition, tolerances are currently established for residues of pr opoxycarbazone per se in selected livestock commodities at 0.03

- 0.3 ppm [40 CFR §180.600(a)(2)]. There are currently no Section 18 Emergency Exemptions, tolerances with regional registrations, or tolerances for indirect/inadvertent residues in rotational
crops.

Adequate methods are available for enforcing the current plant and livestock tolerances. In all available magnitude of the residue and processing studies, samples were analyzed using either the current enforcement methods or a slightly modified ve rsion of current enforcement methods.

The analytical method has been deemed acceptable ; however HED concluded the method instructions should be modified to clearly state that propoxycarbazone

- sodium as the free acid is the compound to be used for preparat ion of standard and fortification solutions. The method description need s to specify any chemical information for the standards to clarify which compound is to be used (Memo, G. Kramer, 22

- APR

- 2004; D284670).

The nature of the residue in wheat/grass and livestock is adequately understood based on available metabolism studies. For risk assessment purposes, only parent will be considered for plant and livestock commodities. Adequate field trial and processing data are available to support the use of propo xycarb az one

- sodium on the registered crops. An adequate number of trials were conducted in the appropriate geographical regions using the appropriate formulation applied at the maximum use rate. Registration requirements for magnitude of the residue in

m eat, milk, poultry, and e ggs are fulfilled.

A previous condition of registration was the need for additional grass field trials reflecting a preharvest interval (PHI) of 7

- day s for hay (Memos, S. Levy, 25

- SEP

- 2013 ; D412002 and D412251). However, upon f urther evaluation of the previously

- submitted field trial data , HED is no longer requiring these additiona l trials. Based on the complete 0

- day forage data set, a hay decline study, and the theoretical drying factor and moisture content of forage to hay ( ~3 fold ), residues can be extrapolated for hay at 7 days (calculated to be a maximum of

~ 12 ppm ). The currently

- established 25

- ppm tolerance for grass, hay is adequate to cover any residues detected for hay at the PHI of 7 days.

The residue chemistry d atabase is adequate to support current Registration Review data requirements. Adequate metabolism (crops, livestock, and rotational crops), storage stability, magnitude of the residue, and processing data are available to support the registered uses. Ade quate methods are available for enforcement of the currently established tolerances.

2 http://www.epa.gov/endo/Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 13 of 29 

### 5.2 Drinking Water

The residues of concern in drinking water are adequately understood based on available environmental fate studies. The HED Metabolism Assessment Re view Committee ( MARC ) concluded that the residue of concern for the drinking water risk assessment should include the parent compound plus propoxycarbazone

- carboxylic acid (MKH 8394) (Report of the Metabolism Assessment Review Committee

– MARC, G. Kramer, 19

- APR

- 2004; D2 99170 ).

Updated groundwater EDWCs for propoxycarbazone

- sodium were provided by EFED (Memo, J. Lin, 0 4

- DEC

- 2014; D423552). The EDWCs were derived using the Pesticide Root Zone Model

Ground Water (PRZM

- GW) model and assuming maximum applicat ion rates. The surface water concentrations are on the same order of magnitude as the ground water concentrations. For acute exposure, the surface water concentration ( 4.16 μg/L ) is higher than that for ground water, whereas for chronic exposure, the ground water value ( 2.8 μg/L ) is higher. These results are similar to previous drinking water assessment results, with an increase in ground water estimates relative to pre vious estimates (D 3 48511): surface water acute, 4.59 μg/L; surface water chronic, 1.79 μg/L; ground water acute and chronic, 0.36 μg/L.

5.3 Dietary (Food + Drinking Water ) Risk Assessment

In support of Registration Review, an updated chronic dietary (foo d + drinking water) exposure and risk assessment was conducted using DEEM

- FCID (ver. 3. 16 ) which incorporates consumption data from the USDA NHANES/WWEIA; 2003

- 2008. The chronic analyses assumed tolerance

- level residues, 100% CT, DEEM (ver. 7.81) default processing factors, and modeled drinking water estimates. The groundwater EDWC of 0.0028 ppm was incorporated directly into the chronic dietary analyses as “water, direct, all sources” and “water, indirect, all sources.” The groundwater EDWC used the mod eled application rate of 0.0525 lb a

. i

. /acre to represent the maximum use pattern of the proposed end

- use labels and current registered labels. The chronic dietary (food + drinking water) exposure estimates are below HED’s LOC (<100% cPAD) for the general U.S. population and all population subgroups (<1% of the cPAD) (see Table 5.3.1). The residue file for the chronic assessment as well as the results of the chronic assessment are provided in Attachment 4. An acute dietary (food + d rinking water) exposure and risk assessment was not conducted for propoxycarbazone

- sodium because an endpoint of concern attributable to a single oral dose was not selected for any population subgroup (including infants and children). Propoxycarbazone

- sod ium was classified as “not likely to be carcinogenic to humans”; therefore, a cancer dietary assessment was not performed.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 14 of 29 Table 5.3.1. Summary of Chronic Dietary (Food + Drinking Water) Exposure and Risk for Propoxycarbazone

- sodium

. 1
Population Subgro up cPAD (mg/kg/day) Exposure (mg/kg/day) %cPAD
General U.S. Population

0.7 0.000320 <1 All Infants (<1 year old) 0.000530 <1
Children 1

- 2 years old 0.001513 <1 Children 3

- 5 years old 0.000919 <1 Children 6

- 12 years old 0.000539 <1
Youth 13

- 1 9 years old 0.000274 <1
Adults 20

- 49 years old 0.000220 <1
Adults 50

- 99 years old 0.000203 <1 Females 13

- 49 years old 0.000219 <1
1 The population subgroup with the highest exposure is in bold.



### 6 .0 Residential (Non

- Occupational ) Exposur e and Ris k Assessment

There are no proposed or registered products containing propoxycarbazone

- sodium that would result in residential exposure . Therefore, a residential exposure assessment was not performed.

6.1 Spray Drift

Off

- target movement of pesticides ca n occur via many types of pathways and it is governed by a variety of factors. Sprays that are released and do not deposit in the application area end up off

target and can lead to exposures to those it may directly contact. They can also deposit on surf aces where contact with residues can eventually lead to exposures (e.g

. , children playing on lawns where residues have deposited next to treated fields). The potential risk estimates from these residues can be calculated using drift modeling coupled with methods employed for residential risk assessments for turf products.

The approach to be used for quantitatively incorporating spray drift into risk assessment include assessing exposures for children (1 to 2 years old) and adults who have contact with tu rf where residues are assumed to have deposited via spray drift thus resulting in an exposure scenario. Aside from the predicted residues available for transfer, the routes of exposure and assessment methodology is analogous to how exposures to turf produ cts are considered in risk assessment.

In order to evaluate the drift potential and associated risks, an approach based on drift modeling coupled with techniques used to evaluate residential uses of pesticides was utilized. Essentially, a residential t urf assessment based on exposure to deposited residues has been completed to address drift from the agricultural applications of propoxycarbazone

- sodium . In the spray

- drift scenario, the deposited residue value was determined based on the amount of spray drift that may occur at varying distances from the edge of the treated field using the AgDrift ® 

### (v2.1.1) model. Exposures were considered for 50

- feet wide lawns where the nearest side of the property was directly adjoining the treated field (at field edge ) and at varied distances up to 300 feet downwind of a treated field. Once the deposited residue values were determined, the remainder of the spray

- drift assessment was based on the algorithms and input values specified in the recently revised (2012) Stan dard Operating Procedures For Residential Risk Assessment (SOPs)

.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 15 of 29 

### A screening approach was developed for situations where specific label guidance for application parameters is not available. 3 

### AgDrift ® 

### is appropriate for use only when applications are made by aircraft, airblast sprayers, and groundboom sprayers. When AgDrift ® 

### was developed, a series of screening values (i.e., the Tier 1 option) were incorporated into the model and represent each equipment type and use under varied conditions. The scre ening options specifically recommended in this methodology were selected because they are plausible and represent a reasonable upper

- bound level of drift for common application methods in agriculture. In all cases, each scenario is to be evaluated unless it is not plausible based on the anticipated use pattern (e.g., herbicides are not typically applied to tree canopies) or specific l abel prohibitions (e.g., aerial applications are not allowed). Section 6.1 .1 provides the screening

- level drift

- related ris k estimates. These drift estimates represent plausible options based on the available pesticide labels

. 6.1.1 Combined Risk Estimates From Lawn Deposition Adjacent to Applications

The spray

- drift risk estimates are based on an estimated deposited resid ue concentration as a result of the screening level agricultural application scenarios. Propoxycarbazone

- sodium is an herbicide registered for use on wheat and pastures / r angeland and can be applied via groundboom and aerial equipment. The recommended dri ft scenario screening level options are listed below:

 Groundboom applications are based on the AgDrift ® 

### option for high boom height and using very fine to fine spray type using the 90 th 

### percentile results.

 Aerial applications are based on the use of AgD rift ® 

### Tier 1 aerial option for a fine to medium spray type and a series of other parameters

, which will be described in more detail below (e.g., wind vector assumed to be 10 mph in a downwind direction for entire application/drift event). 4



### There are no sh ort

- or intermediate

- term dermal PODs. Only incidental oral risk estimates were evaluated. The total applicable LOC is 100

, so MOEs <100 would be of concern. Children (1 to <2 year s old) incidental oral risk estimates from exposure to propoxycarbazone

- s odium related to spray drift result in no risks of concern at the field edge for either groundboom or for aerial applications (Table 6.1.1.1)

.

Table 6.1.1.1. Children (1 to <2 years old) Incidental Oral Risk Estimates (MOEs) Related to Spray

- Drift Exposu re for Propoxycarbazone

- sodium

.
Crop Application

Method Spray Type/Nozzle

Configuration Application Rate (lb a

. i

. /A) Estimated

TTR t (ug/cm2) At Edge

HtM MOE

Wheat Aerial Fine to Medium 0.04 0.0044 640,000

Groundboom High Boom Very fine to Fine 880,000

Pastureland / Rangeland Aerial Fine to Medium 0.05 0.0056 510,000

Groundboom High Boom Very fine to Fine 700,000

3 http://www.agdrift.com/
4 AgDrift ® allows for consideration of even finer spray patterns characterized as very fine to fine. However, this spray pattern was not selected as the common screening ba sis since it is used less commonly for most agriculture.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 16 of 29 

### 6.2 Residential Bystander Post

- Application Inhalation Exposure

Volatilization of pesticides may be a source of post

- applicati on inhalation exposure to individuals nearby pesticide applications. The A gency sought expert advice and input on issues related to volatilization of pesticides from its FIFRA Scientific Advisory Panel (SAP) in December 2009, and received the SAP’s final report on March 2, 2010 5 

### . The A gency has evaluated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis 6 

### . During Registration Review, the A gency will utilize this analysis to determine if dat a (i.e., flux studies, route

- specific inhalation toxicological studies) or further analysis is r equired for propoxycarbazone

- sodium

.

7 .0 Aggregate Exposure and Risk Assessment

The most recent aggregate

- risk assessment for propoxycarbazone

- sodium was perf ormed in conjunction with the 200 8 HED human health risk assessment ( Memo, S. Levy et al. , 1 0

- DE C

200 8 ; D 348510 ). Since there are no residential uses, the chronic dietary (food + drinking water) exposure estimates represent chronic aggregate exposure. Up dated chronic dietary (food + drinking water) exposure and risk assessments were conducted to include the updated EDWC and 2003

- 2008 NHANES/WWEIA consumption data (discussed in Section 5.3). T he chronic aggregate (food + drinking water) exposure and risk estimates did not exceed HED's LOC.

An acute aggregate risk assessment was not performed because an endpoint of concern attributable to a single oral dose was not selected for any population subgroup (including infants and children). Short

- and interme diate

- term aggregate risk assessments were not performed because there are no registered residential uses. A cancer aggregate risk assessment was not performed because propoxycarbazone

- sodium is not classified by HED as “not likely to be carcinogenic to h umans.”

8.0 Cumulative Exposure/Risk Characterization

Unlike other pesticides for which EPA has followed a cumulative risk approach based on a common mechanism of toxicity, EPA has not made a common mechanism of toxicity finding as to propoxycarbazone

- sodium and any other substances and propoxycarbazone

- sodium does not appear to produce a tox ic metabolite produced by other substances. For the purposes of this action, therefore, EPA has assumed that propoxycarbazone

- sodium does not have a common mechani sm 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 the policy statements released by EPA’s Office of Pesticide Programs concerning common mechanism determinations and procedures for cumulating effects from substances found to have a common mechanism on EPA’s website at http://www.epa.gov/pesticides/ cumulative/

.

5 http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html

6 http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2014

- 0219Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 17 of 29 

### 9 .0 Occupational Exposure

Occupational handler and post

- application exposures are expected based on the registered agricultural uses of propoxycarbazone

- sodium

. Table A.3.1 in Attachment 3 provide s a summary of the registered use pattern

. Based on the registered use pattern , there is a potential for exposure to propoxycarbazone

- sodium in occupational settings from handling propoxycarbazone

- sodium products during the application process (i.e., mixer/loaders, applicators, and mixer/loader/ applicators). In addition, there is a potential for post

- application worker exposure from entering into areas previously treated with propoxycarbazone

- sodium

.

9 .1 Occupational Handlers

Occupational handlers are anticipated to have short

- and intermedia te

- term dermal and inhalation exposures. However, since no short

- or intermediate

- term dermal PODs were selected, only inhalation exposures are assessed. In support of Registration Review, an updated occupational exposure assessment for propoxycarbazone

- sodium was conducted for mixers/loaders, applicators, and flaggers for aerial and groundboom applications of a DF formulation , as well as mixer/loader/applicators performing spot treatments with handheld equipment . The assessment was based on the maximum registered application rate of 0.05 lb a

. i

. /A (0.002 lb a

. i

. /gallon) , and maximum area treated per day or gallons handled. Handler exposure and risk were calculated at baseline (long pants, a long

- sleeved shirt, no chemical

- resistant gloves, and no respir ator) and with personal

- protective equipment (PPE) when necessary [ e.g., engineering controls (EC)]

. Inhalation risk estimates were not of concern (i.e., MOEs ≥ 100) with baseline protection and/or engineering controls (representative of aerial applicator s in enclosed cabs) ( see Table 9 .1.1 ). P PE on registered labels recommends mixers/loaders and other handlers to wear long sleeved shirts, long pants, chemical

- resistant gloves, shoes plus s ocks, and protective eyewear.

Table 9 .1.1 . Summary of Occupati onal Handler Inhalation Risks fo r Propoxycarbazone

- sodium.

Activity Application Equipment Crop/Target Inhalation Unit Exposure (μg/lb ai) 1 App

Rate 2 Acres

Treated

or Gallons Handled 3 Dose 4 ST and IT Inhalation MOE 5

Mixer/Loader Groundboom application of DF formulation Wheat, Triticale,

Pastureland / Rangeland 8.96 (baseline) 0.05 lb

a

. i

. /A 200 A 0.0011 67, 000 (baseline)

Aerial application of DF formulation 1,200 A 0.0067 11,000 (baseline)
Applicator Applicator, Open Cab Groundboom Wheat,

Pastureland / Rangeland 0.34 (baseline) 0.05 lb

a

. i

. /A 200 A 0.000043 1,800 ,000 (baseline)
Applicator, Aerial 0.0049 (EC) 1,200 A 0.0 00003 7 20 ,000,000 (EC)
Flagger

Aerial Wheat,

Pastureland / Rangeland 0.35 (baseline) 0.05 lb

a

. i

. /A 350 A 0.000077 980 ,000 (baseline)

Mixers/Loaders/Applicators Backpack Pastureland /

Rangeland 140 0.002 lb

a

. i

. / gallon 40 gallons 0.00014 540,000 (base line) Manually

- pressurized Handwand 30 0.00003 2,500,000 (baseline) Mechanically

- 3.9 1000 0.000098 770,000 (baseline)Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 18 of 29 pressurized Handgun gallons

1 Based on the “Occupational Pesticide Handler Unit Exposure Surrogate Reference Table” (March 2013); Level of mitigation: Baseline, EC = Eng. Controls.

2 Based on registered labels.

3 Exposure Science Advisory Council Pol icy #9.1.

4 Inhalation Dose = Inhalation Unit Exposure (μg/lb ai) × Conversion Factor (0.001 mg/μg) × Application Rate (lb a

. i

. /acre or lb a

. i

. /gallon ) × Area Treated or Amount Handled (A or gallons /day) × absorption factor (100%) ÷ BW (80 kg).

5 Inhalation MOE = Inhalation NOAE L ( 75 mg/kg/day) ÷ Inhalation Dose (mg/kg/day).



### 9 .2 Occupational Post

- Application

Dermal : Typically, it is possible for agricultural workers to have post

- application exposure to pesticide residues during the course of typical agricultural activities. However the Agency did not identify a dermal toxicological endpoint; therefore, a quantitative assessment for dermal post

- application exposure was not conducted.

The restricted

- entry interval (REI) specified on the registered labels is based on the acut e toxicity of the a

. i

. Propoxycarbazone

- sodium is classified as Toxicity Category IV via the dermal route and for skin irritation potential. It is not a skin sensitizer. Under 40 CFR 156.208 (c) (2) (iii), ai’s classified as Acute III or IV for acute de rmal, eye irritation and primary skin irritation are assigned a 12

- hour REI. Therefore, the [156 subpart K] Worker Protection Statement (WPS) interim REI of 12 hours is adequate to protect agricultural workers from post

- application exposures to propoxycar bazone

- sodium . It should be noted that several of the registered products contain another a.i. that should be considered when selecting the REI for the product.

Inhalation : There are multiple potential sources of post

- application inhalation exposure to individuals performing post

- application activities in previously treated fields. These potential sources include volatilization of pesticides and resuspension of dusts and/or particulates that contain pesticides. The Agency sought expert advice and input on issues related to volatilization of pesticides from its FIFRA SAP in December 2009, and received the SAP’s final report on March 2, 2010 ( http://www.epa.gov/scipoly/SAP/meetings/2009/120109meeting.html ). In terms of volatilization, the Agency has eval uated the SAP report and has developed a Volatilization Screening Tool and a subsequent Volatilization Screening Analysis ( http://www.regulations.gov/#!docketDetail;D=EPA

- HQ

- OPP

- 2014

- 0219 ). During Registration Review, the Agency will utilize this analysis to determine if data (i.e., flux studies, route

- specific inhalation toxicological studies) or further analysis is required for specific chemicals.

In addition, the Agen cy is continuing to evaluate the available post

- application inhalation exposure data generated by the ARTF . Given these two efforts, the Agency will continue to identify the need for and, subsequently, the way to incorporate occupational post

- application inhalation exposure into the Agency's risk assessments.

Although a quantitative occupational post

- application inhalation exposure assessment was not performed, an inhalation exposure assessment was performed for occupationa l/commercial handlers. Handler exposure resulting from application of pesticides outdoors is likely to result in higher exposure than post

- application exposure. Therefore, it is expected that these handler inhalation exposure estimates would be protective of most occupational post

- appl ication inhalation exposure scenarios. Based on this, HED concludes that additional data pertaining to assessment of post

- application inhalation exposure are unnecessary.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 19 of 29 

### 10 .0 Public Health and Pesticide Epidemiology Data

The Agency has reviewed the available incident data for propoxycarbazone

- sodium (Memo , E. Evans and S. Recore, 21

- JAN

- 201 5 ; D 425154 )

. I t is noted that there was one incident reported involving propoxycarbazone

- sodium in both the Aggregate Incident Data System (IDS) and the Sentinel Event Notification System for Occupational Risk (SENSOR)

- Pesticides database s

. Based on the low frequency and low severity of cases involving propoxycarbazone

- sodium, there does not appear to be a concern at this time that would warrant further investigat ion. The Agency will continue to monitor the incident information and if a concern is triggered, additional analysis will be included in the risk assessment.

11 .0 References

HED Memoranda Relevant to Registration Review.
Author Barcode Date Title
Mark I. Dow D301651 22

- Apr

- 2014 PROPOXYCARBAZONE

- SODIUM

- Exposure/Risk Assessment for the Use of Propoxycarbazone

- sodium on Wheat

. Mark I. Dow D349694 17

- Mar

- 2008 PROPOXYCARBAZONE

- SODIUM

- Occupational Exposure/Risk Assessment for the Proposed Use of Propoxy carbazone

- sodium on Pastures and Rangeland

. E. Evans and S. Recore D 425154 21

- JAN

- 2015 Propoxycarbazone

- sodium: Tier I Review of Human Incidents

. G. Kramer D293677 22

- SEP

- 2003 PP#1E06302. Multiresidue Method (MRM) Testi ng of Propoxycarbazone

- sodium. S. Levy D412002 25

- SEP

- 2013 Propoxycarbazone

- sodium; Response to the Health Effects Division (HED) Review of 05

- AUG

- 2009. S. Levy et al. D348510 10

- DEC

- 2008 Propoxycarbazone

- sodium. Human Health Risk Assessment for Proposed Section 3 New Use on Pasture and Rangeland Grasses. J. Lin D423552 04

- DEC

- 2014 Propoxycarbazone

- sodium: Drinking Water Exposure Assessment for Registration Review. G. Kramer D299170 19

- APR

- 2004 MARC Report

. U. Habiba TXR# 0057073 18

- NOV

- 2014 Propoxycarbazone

- sodium: Summary of the Ha zard and Science Policy Council (HASPOC) Meeting on October 9, 2014. Recommendations on the Requirement of a Subchronic Inhalation Study

.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 20 of 29 

### Attachment 1: Chemical Identity Tables.

Table A.1.1. Nomenclature of Propoxycarbazone

- sodium and its Regulated Metabolite.

Chemical Structure

Common name Propoxycarbazone

- sodium Company experimental names AE 1169718, MKH 6561
IUPAC name S odium {[2

- (methoxycarbonyl)phenyl]sulfonyl}[(4,5

- dihydro

- 4

- methyl

- 5

- oxo

- 3

- propoxy

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]azanide
CAS name Methyl 2

- [[[(4,5

- dihydro

- 4

- methyl

- 5

- oxo

- 3

- propoxy

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl] amino]sulfonyl]benzoate, sodium salt
CAS # 181274

- 15

- 7 (sodium salt); 145026

- 81

- 9 (acid)
Chemical Structure

Common Name 2

- OH Propoxycarbazone Company Experime ntal Name AE 1364270, Pr

- 2

- OH

- MHK 6561Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 21 of 29 Table A.1.2

. Physicochemical Properties of Propoxycarbazone

- sodium (sodium salt).

Parameter Value Reference Boiling range 230

- 240oC MRID#: 46580801
pH (at 24oC) 6.6 Density (g/mL at 20oC) 1.42
Water solubi lity (mg/L at 20°C) 42 Solvent solubility (g/L at 25°C) DMSO 190 Acetonitrile 0.90 Acetone 0.50 PEG 5.2 Methylene Chloride 1.5 Heptane <1 Zylene <1 Isopropanol <1 Octanol <1 Ethyl Acetate <1 Vapor pressure (Torr at 20°C) 7.50 x 10

- 11
Dissociation con stant (pK a ) 2.1 Octanol/water partition coefficient (K OW ) at 20oC 0.028
UV/visible absorption spectrum (  max, nm) Primary: 200 Secondary: 232 Tertiary: 275Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 22 of 29 

### Attachment 2: Propoxycarbazone

- Sodium Acute, Subchronic, and Chronic Toxicity Profile.

Study requirements (40 CFR 158.340) for propoxycarbazone

- sodium are presented below. Use of the new guide line numbers does not imply that the new (1998) guideline protocols were used.

Table A.2.1. Toxicology Study Requirements.
Study Technical Required Satisfied 870.1100 Acute Oral Toxicity

................................ ...................... 870.1200 Acute Dermal Toxicity

................................ ................. 870.1300 Acute Inhala tion Toxicity

................................ ............. 870.2400 Acute Eye Irritation

................................ ...................... 870.2500 Acute Dermal Irritation

................................ ................. 870.2600 Skin Sensitization

................................ ......................... yes yes yes yes yes yes yes

yes yes yes yes yes 870.3100 90

- Day Oral Toxicity (rodent)

................................ ...... 870.3150 90

- Day Oral Toxicity (nonrodent)

................................ 870.3200 21/28

- Day Dermal Toxicity

................................ .......... 870.3250 90

- Day Dermal Toxicity

................................ ............... 870.3465 90

- Day Inhalation Toxicity

................................ ........... yes yes yes

no

no 1 yes

yes yes

--

-- 870.3700a Prenatal Developmental Toxicity (rodent)

.................... 870.3700b Prenatal Developmental Toxicity (nonrod ent)

.............. 870.3800 Reproduction and Fertility Effects

................................ yes yes yes yes

yes yes 870.4100a Chronic Toxicity (rodent)

................................ ............. 870.4100b Chronic Toxicity (nonrodent)

................................ ....... 870.4200a Carcinogenicity (rat)

................................ ..................... 870.4200b Carcinogenicity (mouse)

................................ ............... 870.4300 Combined Chronic Toxicity/Carcinogenicity

............... yes yes yes yes yes yes 2

yes yes 2
yes yes 870.5100 Mutagenicity

— Bacterial Reverse Mutation Test

......... 870.5300 Mutagenicity

— Mammalian Cell Gene Mutation Test

. 870.5xxx Mutagenicity

— Structural Chromosomal Aberrations

. 870.5x xx Mutagenicity

— Other Genotoxic Effects

...................... yes yes yes yes yes

yes yes yes 870.6200a Acute Neurotoxicity Screening Battery (rat)

................ 870.6200b 90

- Day Neurotoxicity Screening Battery (rat)

.............. 870.6300 Developmental Neurotoxicity

................................ ....... yes yes

no yes

yes

-- 87 0.7485 Metabolism and Pharmacokinetics

............................... 870.7600 Dermal Penetration

................................ ....................... 870.7800 Immunotoxicity

................................ ............................ yes

no yes yes

-- yes
1 HED HASPOC concluded that the subchronic inhalation is not required at this time (U. Habiba; 18

- NOV

- 2014; TXR#0057073).

2 The co mbined chronic toxicity/carcinogenicity study satisfies the requirement of the study.

Table A.2.2. Acute Toxicity Profile

– Propoxycarbazone

- sodium

. Guideline No. Study Type MRID(s) Results Toxicity Category

870.1100 Acute Oral (rat) 45012509 LD 5 0 > 5000 mg/kg IV

870.1200 Acute Dermal 45012507/45012508 LD 50 > 5000 mg/kg IV

870.1300 Acute Inhalation 45012505 LC 50 > 5.03 mg/L IV

870.2400 Primary Eye Irritation 45012504 Minimally irritating IV

870.2500 Primary Skin Irritation 45012504 Slightly irritating IV

870.2600 Dermal Sensitization 45012510 Not a dermal sensitizer N/APropoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 23 of 29 

### Note: It is recognized that some studies in the propoxycarbazone

- sodium database have conservative NOAEL/LOAEL values that are based on effects t hat are not considered adverse according to current HED policy (e.g., body

- weight gain). These updates, however, would result only in higher NOAEL/LOAEL values in studies that were not used for endpoint selection; therefore, the updates would not affect c urrent PODs . Consequently, given the current risk picture for propoxycarbazone

- sodium, the Agency did not find it necessary to update these studies at this time; however, if the risk picture changes, then these studies may need to be updated in the future

.

Table A.2.3. Subchronic, Chronic, and Other Toxicity Profile

– Propoxycarbazone

- sodium

. Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results

870.3100 90

- Day oral toxicity (rat) 45012610 (1998)

Acceptable/guideline 0, 250, 1000 , 4000 or 20,000 ppm M: 0, 21.6, 81.6, 350.6

, or 1769.9 mg/kg/ day F: 0, 17.4, 73.0, 286.4

, or 1507.5 mg/kg/ day NOAEL = 286.4/350.6 mg/kg/day (M/F)

. LOAEL = 1507.5/1769.9 mg/kg/day (M/F) based on gastric irritation.

870.3100 90

- Day oral toxicity (mouse) 45012521 (1997)

Acceptable/guideline 0, 625, 2500 or 10,000 ppm M: 0, 205, 860

, or 3926 mg/kg/ day F: 0, 307, 1159

, or 5109 mg/kg/ day NOAEL = 205/1159 mg/kg/day (M/F)

. LOAEL = 860/5109 mg/kg/day (M/F) based on decreased body weight, body

- weight gain, and fo od efficiency.

870.3150 64

- Day oral toxicity (dog) (range

- finding) 45012511 (1997)

Acceptable/guideline 0, 1000, 5000, 10,000 or 40,000
ppm M: 0, 28, 140, 332, and 1407 mg/kg bw/ day F: 0, 32, 134, 286

, or 1181 mg/kg/ day NOAEL = 1407/1181 mg/kg/day (M /F)

. LOAEL = not determined

.

870.3200 21/28

- Day dermal toxicity 45012530 (1997)

Acceptable/non

- guideline 0 or 1000 mg/kg/day NOAEL = 1000 mg/kg/day

. LOAEL = not determined

. 870.3700a Prenatal developmental rodent (rat) 45012515 (1997)

Acceptable/guidel ine 0, 100, 300, or 1000 mg/kg/ day Maternal NOAEL  1000 mg/kg/day

. LOAEL = not determined

. Developmental NOAEL  1000 mg/kg/day

. LOAEL = not determined

.

870.3700b Prenatal developmental in nonrodents (rabbit) 45012608 (1998)

Acceptable/guideline 0, 20, 1 00, 500

, or 1000 mg/kg/day Materna l NOAEL = 100 mg/kg/day

. LOAEL = 500 mg/kg/day based on reduced body

weight gain and food consumption, gastrointestinal toxicity, and decreased water consumption and urination. Developmenta l NOAEL = 500 mg/kg/day

. LOAEL = 1000 mg/kg/day based on an abortion, decrease in mean fetal weights, and elevated pre

and post

- implantation loss.

870.3800 Reproduction and fertility effects 45012529 (1999)

Acceptable/guideline 0, 1000, 4000, or 16,000 ppm F 0 (M): 0, 74.8, 297.1, or 12 30.7 mg/kg/day F 0 (F): 0, 92.7, 373.5, or 1605.3 mg/kg/d ay F 1 (M): 0, 79.6, 322.9, or 1313.9 mg/kg/d ay Parental/Systemic NOAEL = 74.8

- 79.6 mg/kg/day (M) and 373.5

- 413.5 mg/kg/day (F)

. LOAEL = 297.1

- 322.9 mg/kg/ day (M) and 1605.3

- 1907.5 mg/kg/day (F) based on microscopic lesions of the stomach. Reproductive NOAEL = 373.5

- 413.5 mg/kg/day

. LOAEL = 1605.3

- 1907.5 mg/kg/day based onPropoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 24 of 29 Table A.2.3. Subchronic, Chronic, and Other Toxicity Profile

– Propoxycarbazone

- sodium

. Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results

F 1 (F): 0, 103.8, 413.5, or 1907.5 mg/kg/ d ay increased in diestrous/metestrous in females

. Offspring NOAEL = 297.1

- 322.9 mg/kg/d ay (M) and 373.5

- 413.5 mg/kg/day (F)

. LOAEL = 1230.7

- 1313.9 mg/kg/day (M) and 1605.3

- 1907.5 mg/kg/day (F) based on increased postimplantation loss and decreased live litter size in the F 2 litters. 870.4100a Chronic toxicity (rodent) See 870.4300 See 870. 4300

870.4100b Chronic toxicity (dog) 45012513 (1998)

0, 2000, 10,000

, or 25,000 ppm M: 0, 52.2, 258.0

, or 630.7 mg/kg/ d ay F: 0, 55.7, 235.5, or 605.4 mg/kg/ d ay NOAEL = 630.7 mg/kg/day

. LOAEL > 630.7 mg/kg/day

.

870.4200a Carcinogenicity (rat) See 870 .4300 See 870.4300

870.4200b Carcinogenicity (mouse) 45012614 (1999)

Acceptable/guideline 0, 280, 1400, or 7000 ppm M: 0, 74.6, 369.0, or 1880.9 mg/kg/ d ay F: 0, 126.2, 626.9, or 3106.1 mg/kg/d ay NOAEL = 369 mg/kg/day

. LOAEL = 1880.9 mg/kg/day based on decreased body weight gain combined with lower food efficiency in males.

No evidence of carcinogenicity

.

870.4300 Combined Chronic Toxicity/ Carcinogenicity (rat) 45012514 (1999)

Acceptable/guideline 0, 1000, 10,000 and 20,000 ppm M: 0, 43, 459

, or 924 mg/kg/day F: 0, 49, 525

, or 1049 mg/kg/day NOAEL = 43/49 mg/kg/day (M/F)

. LOAEL = 459/525 mg/kg/day (M/F) based on decreased body weight and increased urinary pH (preceding histological changes in the kidney of rats in the mid

- and high

- dose groups such as: foci of mineralization of pelvis, dilated and cystic renal tubules filled with proteinaceous material, regenerative tubular epithelium, glomerular and interstitial fibrosis, and hyperplasia of the pelvic epithelium).

No evidence of carcinogenicity

.

870.5100 Gene Mutation 45012506 (1994)

Acceptable/guideline 0, 1.6, 8, 40, 200, 1000

, or 5000 μg/plate Negative

870.5100 Gene Mutation 45012516 (1999)

Acceptable/guideline 0, 16, 50, 158, 500, 1581

, or 5000 μg/plate Negative

870.5100 Gene Mutation 45 012528 (1999)

Acceptable/guideline 0, 0.25, 0.5, 1, 2, 4, or 8 μg/plate Negative

870.5300 In vitro Chinese hamsterV79

- HPRT 45012522 (1996)

Acceptable/guideline 0, 500, 1000, 2000, 3000

, or 4000 μg/mL Negative

Cytogenetics 870.5375 45012527 (1999)

Acceptable/guideline NegativePropoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 25 of 29 Table A.2.3. Subchronic, Chronic, and Other Toxicity Profile

– Propoxycarbazone

- sodium

. Guideline No./ Study Type MRID No. (year)/ Classification /Doses Results

In vitro Chinese hamst er 0, 625, 1250

, or 2500 μg/mL

870.5375 In vitro Chinese hamster 45012613 (1996)

Acceptable/guideline 0, 500, 2500 or 5000 μg/mL Negative

870.5395 Hsd/Win: NMRI mouse bone marrow micronucleus 45012603 (1995)

Acceptable/guideline 2500 mg/kg Negative

870.5550 Unscheduled DNA Synthesis 45012607 (1996)

Acceptable/guideline 0, 25, 100, 250, 500, 1000, 2000 or 4000 μg/mL Negative

870.6200a Acute neurotoxicity screening battery 45012512 (1997)

Acceptable/guideline 2000 mg/kg NOAEL = 800 mg/kg

. LOAEL = 2000 mg/kg based on a decrease in body weight gain in females

. 870.6200b Subchronic neurotoxicity screening battery 45012609 (1998)

Acceptable/guideline 0, 1000, 4000, or 20,000 ppm M: 0, 64, 252, or 1321 mg/kg/d ay F: 0, 79, 312, or 1651 mg/kg/d ay NOAEL: 1321/1651 mg/kg/day (M/F)

. LOAEL = not established

.

870.7485 Metabolism and pharmacokinetics 45012631 (1999)

Acceptable/guideline 2 or 200 mg/kg Absorption in male rats was ~25% after administration of 2 mg/kg and slightly decreased to ~21% with a single dose of 200 mg/kg. Absorption in female rats was slightly higher (~31%) after 2 mg/kg. Radiolabel position did not influence absorption. Plasma T max was rapid at ~0.33 hours regardless of radiolabel position in rats that received 2 mg/kg and ~0.81 hours in rats that received 200 mg/kg. No bioac cumulation or tissue reservoirs were found. Plasma clearance was biphasic and rapid, with a T 1⁄2 for the first phase of ~1.1 hours for the compound labeled in the triazol posi tion and ~0.6 hours for the compound labeled in the phenyl position, regardless of dose. No radiolabel effects were noted in the second phase plasma T1⁄2

, which was ~11 hours at 2 and 200 mg/kg. The radiolabeled test material was primarily eliminated unchanged in the urine and feces (~75

- 88% of the administered dose), with essentially none eliminated by the lungs. Of the absorbed radiolabeled test material, ~90% was excreted into the urine while the remaining was recovered from the bile. However, rad iolabel position did influence the metabolic products.

870.7800 Immunotoxicity 49072705 (2012)

Acceptable/guideline 0, 600, 1800, or 5400 ppm (0, 119, 370, or 1106 mg/kg/day) NOAEL = 1106 mg/kg/day

. LOAEL = not established

.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 26 of 29 

### A ttachment 3 : Registered Propoxycarbazone End Use Products and Use Patterns

.

Table A.3.1. Summary of Registered Us es for Propoxycarbazone

- sodium

.

Product Name Formulation Use Site Maximum Application Rate and Application Method PHI 1

(days) RTI 2

(days) REI 3

(hours)

Olympus 70% Water Dispersible (264

- 809)

Dry Flowable Wheat (spring, durum, winter), Triticale 0.04 lb a

. i

. / A

Aerial, Groundboom

Preplant,
preemergence,

or postemergence 0 for

forage and 71 for grain/straw Fall and

spring applications allowed; 15 days between apps fo r burndown 12

Olympus Flex Herbicide (264

- 833) 4 Wheat

, Triticale 0.015 lb a

. i

. / A

Aerial, Groundboom

Postemergence

30 for

forage and 71 for grain/straw Only 1 app

per growing

season 24

Rimfire Herbicide (264

- 847) 4 Wheat , Triticale 0.011 lb a

. i

. / A

Aer ial, Groundboom

Postemergence 12

Rimfire Max Herbicide (264

- 1099) 4 Wheat , Triticale 0.009 lb a

. i

. / A

Aerial, Groundboom

Postemergence 12

Olympus Rangeland Herbicide (264

- 1074) Pastures, Rangeland, Conservation Reserve Program land, Noncrop areas 0.05 lb a

. i

. / A

Aerial, Groundboom

0.002 lb

a

. i

. /gal Handheld equipment

Postemergence Do not cut

for hay within 7 days of
treatment Not

specified; fall and spring applications 12

1 PHI = preharvest interval.

2 RTI = retreatment interval.
3 REI = restricted entry interval.

4 These products contain multiple a.i.’s . The other ai is mesosulfuron

- methyl.Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 27 of 29 

### At tachment 4 : Chronic Dietary Exposure Files

. The following dietary exposure files were reviewed by two peer reviewers (T. Bloom and J. VanAlstine) of the DESA C per DESAC SOP 2012.1.

Filename: C: \ Users \ jlangsda \ Documents \ DEEM Runs for others \ 122019prop_Jan 28 2015.R08 Chemical: Propoxycarbazone sodium RfD(Chronic): .748 mg/kg bw/day NOEL(Chronic): 74.8 mg/kg bw/day RfD(Acute): 0 mg/kg bw/day NOEL(Acute): 0 mg/kg bw/day Date created/last modified: 01

- 28

- 2015/10:53:03 Program ver. 3.16, 03

- 08

- d Comment: Chronic assessment with food and drinking water

----------------------------------------------------------------------------------- EPA Crop Def Res Adj.Factors Comment Code Grp Commodity Name (ppm) #1 #2

---------- ---- ------------------------------- ---------- ------ ------ ------- 1500381000 15 Triticale, flour 0.020000 1.000 1.000 1500381001 15 Triticale, flour

- babyfood 0.020000 1.000 1.000 1500401000 15 Wheat, grain 0.020000 1.000 1.000 1500401001 15 Wheat, grain

- babyfood 0.02000 0 1.000 1.000 1500402000 15 Wheat, flour 0.020000 1.000 1.000 1500402001 15 Wheat, flour

- babyfood 0.020000 1.000 1.000 1500403000 15 Wheat, germ 0.020000 1.000 1.000 150040 4000 15 Wheat, bran 0.020000 1.000 1.000 3100044000 31 Beef, meat 0.050000 1.000 1.000 3100044001 31 Beef, meat

- babyfood 0.050000 1.000 1.000 3100045000 31 Beef, meat, dri ed 0.050000 1.920 1.000 3100046000 31 Beef, meat byproducts 0.300000 1.000 1.000 3100046001 31 Beef, meat byproducts

- babyfood 0.300000 1.000 1.000 3100048000 31 Beef, kidney 0.300 000 1.000 1.000 3100049000 31 Beef, liver 0.300000 1.000 1.000 3100049001 31 Beef, liver

- babyfood 0.300000 1.000 1.000 3200169000 32 Goat, meat 0.050000 1.000 1.000 3200 170000 32 Goat, meat byproducts 0.300000 1.000 1.000 3200172000 32 Goat, kidney 0.300000 1.000 1.000 3200173000 32 Goat, liver 0.300000 1.000 1.000 3300189000 33 Horse, meat 0.050000 1.000 1.000 3500339000 35 Sheep, meat 0.050000 1.000 1.000 3500339001 35 Sheep, meat

- babyfood 0.050000 1.000 1.000 3500340000 35 Sheep, meat byproducts 0.3 00000 1.000 1.000 3500342000 35 Sheep, kidney 0.300000 1.000 1.000 3500343000 35 Sheep, liver 0.300000 1.000 1.000 3600222000 36 Milk, fat 0.030000 1.000 1.000 36 00222001 36 Milk, fat

- baby food/infant formu 0.030000 1.000 1.000 3600223000 36 Milk, nonfat solids 0.030000 1.000 1.000 3600223001 36 Milk, nonfat solids

- baby food/in 0.030000 1.000 1.000 3600224000 36 Milk, water 0.030000 1.000 1.000 3600224001 36 Milk, water

- babyfood/infant form 0.030000 1.000 1.000 3600225001 36 Milk, sugar (lactose)

- baby food/ 0.030000 1.000 1.000 8601000000 86A Water, direct, all sources 0 .002800 1.000 1.000 New Wa

Full comment: New Water # 8602000000 86B Water, indirect, all sources 0.002800 1.000 1.000 New Wa

Full comment: New Water #Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 28 of 29 US EPA Ver. 3.16, 03

- 08

- d
DEEM

- FCID Chronic analysis for PROPOXYCARBAZONE SODIUM NHANES 2003

- 2008 2

- day Residue file name: C: \ Users \ jlangsda \ Documents \ DEEM Runs for others \ 122019prop_Jan 28 2015.R08 Adjus tment factor #2 used. Analysis Date 01

- 28

- 2015/10:53:47 Residue file dated: 01

- 28

- 2015/10:53:03 Reference dose (RfD, Chronic) = .748 mg/kg bw/day COMMENT 1: Chronic assessment with food and drinking water

=============================================== ================================ Total exposure by population subgroup

-------------------------------------------------------------------------------

Total Exposure

----------------------------------- Population mg/kg Percent of Subgroup body wt/day Rfd

-------------------------------------- - ------------ ---------------- Total US Population 0.000320 0.0% Hispanic 0.000375 0.1%
Non

- Hisp

- White 0.000319 0.0 %
Non

- Hisp

- Black 0.000263 0.0%
Non

- Hisp

- Other 0.000336 0.0% Nursing Infants 0.000176 0.0%
Non

- Nursing Infants 0.000689 0.1% Female 13+ PREG 0.000263 0.0% Children 1

- 6 0.001101 0.1% Children 7

- 12 0.000502 0.1% Male 13

- 19 0.000303 0.0% Female 13

- 19/NP 0.000246 0.0% Male 20+ 0.000217 0.0% Female 20+/NP 0.000206 0.0% Seniors 55+ 0.000204 0.0% All Infants 0.000530 0.1% Female 13

- 50 0.000219 0.0% Children 1

- 2 0.001513 0.2% Children 3

- 5 0.000919 0.1% Children 6

- 12 0.000539 0.1% Youth 13

- 19 0.000274 0.0% Adults 20

- 49 0.000220 0.0% Adults 50

- 99 0.000203 0.0% Female 13

- 49 0.000 219 0.0%

-------------------------------------------------------------------------------Propoxycarbazone

- sodium Human Health Risk Assessment D 423232

Page 29 of 29 

### Attachment 5: Propoxycarbazone

- sodium IRLS Sheet.

Table A.5.1. Summary of US and International Tolerances and Maximum Residue Limits. 

### Residue Definition : US Canada Mexico 1 

### Codex 40 CFR 180.600 combined residues of the herbicide propoxycarbazone methyl 2

- [[[(4,5

- dihydro

- 4

- methyl

- 5

- oxo

- 3

- propoxy

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]amino]sulfonyl] benzoate and its metabolite methyl 2

- [[[(4,5

- dihydro

- 3

- (2

- hydroxypropoxy)

- 4

- methyl

- 5

- oxo

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]amino]sulfonyl] benzoate Propoxycarbazole

- sodium: benzoic acid, 2

- [[[((1 Z

)

- (4,5

- dihydro

- 4

- methyl

- 5

- oxo

- 3

- propoxy

- 1 H

- 1,2,4

- triazol

- 1

- yl)hydroxymethylene]amino]sul fonyl]

- methyl ester, sodiu m salt (1:1), including the metabolite benzoic acid, 2

- [[[[4,5

- dihydro

3

- (2

- hydroxypropoxy)

- 4

- methyl

- 5

- oxo

- 1 H

- 1,2,4

- triazol

1

- yl)carbonyl]amino]sulfonyl]

- methyl ester None



### Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 1 

### Codex Grass, forage 20 Grass, hay 25 Wheat, forage 17 Wheat, grain 0.02 0.02 Wheat, hay 0.15 Wheat, straw 0.05 propoxycarbazone methyl 2

- [[[(4,5

- dihydro

- 4

- methyl

- 5

- oxo

- 3

- propoxy

- 1 H

- 1,2,4

- triazol

- 1

- yl)carbonyl]amino]sulfonyl]benzoate 

### Commodity Tolerance (ppm) /Maximum Residue Limit (mg/kg) US Canada Mexico 1 

### Codex Cattle, meat 0.05 Cattle, meat byproducts 0.3 Goat, meat 0.05 Goat, meat byproducts 0.3 Horse, meat 0.05 Horse, meat byproducts 0.3 Milk 0.05 Sheep, meat 0.03 Sheep, meat byproducts 0.3

Completed: M. Negussie; 09/15/14

1 Mexico adopts U.S. tolerances and/or Codex MRLs for its export purposes.