Documents in Support of a 

Significant New Use Rule for 

Premanufacture Notice (PMN) P-14-0510 

Docket ID Number 

EPA-HQ-OPPT-2015-0220 

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 Table of Contents 

1. Sanitized SAT Report for P-14-0510 

2. Sanitized Engineering Report for P-14-0510 

3. Sanitized Exposure Report for P-14-0510 

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Sanitized SAT Report for P-14-0510 

 

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PBT Potential: P2B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil in skin (pchem); poor through the GI 

(analog); and moderate in lung (analog). Concern for surfactant effects on the lung; irritation to 

eye, skin, mucous membranes and lung based on surfactant properties of the compound. 

 Test Data: Based on summary data provided to full study 

reports not available: acute oral LD50 > 2000 mg/kg (OECD 423); (+) skin and eye irritation; (-) 

skin sensitization.

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.5

daphnid 48-h LC50 2.4

green algal 96-h EC50 4.9

fish _ chronic value 0.08

daphnid _ chronic 

value

0.15

algal _ chronic 

value

0.26

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SAR-nearest analog method for 

SAR chemical class = ; solid with mp 

dec >232; S = dispersible at 25 C (P); pH7; effective concentrations based on 100% active 

ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC 

<2.0 mg/L;

*Submitter referenced ECHA summaries to characterize environmental effects. Missing study 

details were noted in these study summaries and, thus, full study reports are needed if the 

submitter would like to use these to characterize the endpoints.

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

8

SARs

SAR Class

Ecotox Category 

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Ecotox Factors Comments: 

 SAT Chair: K.Moran 564-4322

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Sanitized Engineering Report for P-14-0510 

 

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Sanitized Exposure Report for P-14-0510 

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10/29/2014 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-14-0510 Reviewer: Tobias/BC 

 

Results Table: Dose, Concentration, and Days Exceeded Results Summary 

Exposure Scenario1 Water Landfill Stack Air Fugitive Air

Release activity(ies)2; 

exposure calculation(s)3

Drinking Water Fish Ingestion 7Q104

CC =94

PDM 

Days 

Exceeded

LADD ADR LADD ADR LADD

ADR LADD ADR LADD

mg/kg/day mg/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

USE: Max ADR: max 

acute eco

5.28E-04 --- --- --- 2.40E+01 --- --- --- --- --- ---

USE: PDM1 --- --- --- --- 8.37E+00 --- --- --- --- ---

USE: Max LADD --- 1.49E-06 --- --- --- --- --- --- --- --- ---

1

 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 

2 Release activities are from engineering report's Manufacturing (Mfg), Processing (Proc) and Use release activity labels. 

 Multiple release activities are combined in one exposure scenario if their releases occur at same location. 

3

 Exposure calculations are Acute Dose Rate (ADR), Lifetime Average Daily Dose (LADD), and Probabilistic Dilution 

 Model (PDM). There may be one, two, or all three exposure calculations per exposure scenario. 

 CC is the aquatic concentration of concern. 

4

 This column displays concentration values for the 7Q10 streamflow, which is defined as the average daily streamflow 

 of the seven consecutive days of lowest flow within a ten year period. 

Remarks: 

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10/29/2014 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-14-0510 Assessor: Tobias/EN

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites 

Release Activity: USE: Max ADR

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases:

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr:

Per Site Release:

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-14-0510 

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 Number of Sites RELEASE ACTIVITY:USE: Max 

ADR

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT 

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 1.26 3.16 5.18 6.25

ALL 10 3.92 13.94 23.99 28.65

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water Results Drinking 

Water Units Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 2.46E-07 7.68E-07 mg/kg/day 0.00 0.00 mg/kg/day

LADCpot 1.89E-05 5.91E-05 mg/L 0.00 0.00 mg/kg

Acute

ADRpot 1.20E-04 5.28E-04 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments: 

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10/29/2014 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-14-0510

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 RELEASE ACTIVITY: USE: Max ADR

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES: 

SIC CODE RESULTS

COC (μg/L)

Percent of 

Year COC 

Exceeded

Number of 

Days COC 

Exceeded

Release 

days/year

Loading 

(kg/site/day)

Waste Water

Treatment (%)

High/Avg

Analysis

94.00 High

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10/29/2014 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-14-0510 Assessor: Tobias/EN

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites 

Release Activity: USE: PDM1

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases:

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr:

Per Site Release:

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 

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10/29/2014 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-14-0510 

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY:USE: 

PDM1

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT 

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 0.44 1.10 1.81 2.18

ALL 10 1.37 4.86 8.37 10.00

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water Results Drinking 

Water Units Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 3.17E-07 9.90E-07 mg/kg/day 0.00 0.00 mg/kg/day

LADCpot 2.44E-05 7.62E-05 mg/L 0.00 0.00 mg/kg

Acute

ADRpot 4.18E-05 1.84E-04 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments: 

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10/29/2014 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-14-0510

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY: USE: PDM1

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES:

SIC CODE RESULTS

COC (μg/L)

Percent of 

Year COC 

Exceeded

Number of 

Days COC 

Exceeded

Release 

days/year

Loading 

(kg/site/day)

Waste Water

Treatment (%)

High/Avg

Analysis

94.00 High

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10/29/2014 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-14-0510 Assessor: Tobias/EN

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: 

Release Activity: USE: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge

STACK FUGITIVE

Total Releases:

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr:

Per Site Release:

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-14-0510 

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3 Number of Sites RELEASE ACTIVITY:USE: Max 

LADD

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT 

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 N/A N/A N/A N/A

ALL 10 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water Results Drinking 

Water Units Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 4.77E-07 1.49E-06 mg/kg/day 0.00 0.00 mg/kg/day

LADCpot 3.67E-05 1.15E-04 mg/L 0.00 0.00 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-14-0510

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY:USE: Max 

LADD

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT 

REMOVAL

(%)

RELEASE

DAYS

PRETREATMENT 

RELEASE 

(kg/site/day)

POSTTREATMENT 

RELEASE 

(kg/site/day)

DWT

(%) BCF

(L/kg)

 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT 

TYPE

% ILE

FACILITY

STREAM FLOW (MLD) STREAM CONC. (μg/l)

Harmonic 

Mean 30Q5 7Q10 1Q10

Harmonic 

Mean 30Q5 7Q10 1Q10

ALL 50 N/A N/A N/A N/A

ALL 10 N/A N/A N/A N/A

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units

Drinking Water Results Drinking 

Water Units Fish Ingestion Results

Fish 

Ingestion 

Units

50% 10% 50% 10%

Cancer

LADDpot 4.77E-07 1.49E-06 mg/kg/day 0.00 0.00 mg/kg/day

LADCpot 3.67E-05 1.15E-04 mg/L 0.00 0.00 mg/kg

Acute

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments: 

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