# Documents in Support of a

Significant New Use Rule for

Premanufacture Notice (PMN) P-14-0510

Docket ID Number

EPA-HQ-OPPT-2015-0220

# 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

# Sanitized SAT Report for P-14-0510

### PBT Potential: P2B1

*CEB FATE: Migration to ground water = negl

Health :

Health Summary: Absorption is nil in skin ( p che m ); p oor 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); p H7; 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

( p pb) 8

SARs

SAR Class

Ecotox Category

### Ecotox Factors Comments:

SAT Chair: K.Moran 564-4322

# Sanitized Engineering Report for P-14-0510

# Sanitized Exposure Report for P-14-051010/29/2014



### POST FOCUS EXPOSURE REPORT

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

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

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air

Release activity(ies) 2 ;

exposure c alculation(s) 3 Drinking Water Fish Ingestion 7Q10 4

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 LA DD

--- 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:10/29/2014

POST FOCUS EXPOSURE REPORT

Chemical ID : P

- 14

- 0510 Assessor: Tobias/EN

ENVIRONMENTAL RELEASES

Scenario#: 1 Number of Release Sites

R elease 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:10/29/2014

POST FOCUS EXPOSURE REPORT

Chemical ID : P- 14 -0510

SIC

- CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SC ENARIO #: 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

Expos ure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish

Ingestion

Units

50% 10% 50% 10%

Cancer

LADD pot 2.46E

- 07 7.68E

- 07 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 1.89E

- 05 5.91E

- 05 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 1.20E

- 04 5.28E

- 04 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments: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 High10/29/2014

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: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 EXPOS URE 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

LADD pot 3.17E

- 07 9.90E

- 07 mg/kg/day 0.00 0.00 mg/kg/da y

LADC pot 2.44E

- 05 7.62E

- 05 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 4.18E

- 05 1.84E

- 04 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:10/29/2014

POST FOCUS EXPOSURE REPORT

Chemical ID: P- 14

- 0510

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SC ENARIO # : 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 Wate r

Treatment (%) High/Avg

Analysis

94.00 High10/29/2014

POST FOCUS EXPOSURE REPORT

Chemical ID : P

- 14

- 0510 Assessor: Tobias/EN

ENVIRONMENTAL RELEASES

Scenario#: 3 Number of Release Sites:

Release Activity: US E: 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 Relea se:

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

Remarks:10/29/2014

POST FOCUS EXPOSURE REPORT

Chemical ID : P- 14 -0510

SIC

- CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3 Numbe r 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

(%) BC F

(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

LADD pot 4.77E

- 07 1.49E

- 06 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 3.67E

- 05 1.15E

- 04 mg/L 0.00 0.00 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments:10/29/2014

POST FOCUS EXPOSURE REPORT

Chemical ID : P- 14

- 05 10

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

(%) R ELEASE

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

LADD pot 4.77E

- 07 1.49E

- 06 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 3.67E

- 05 1.15E

- 04 mg/L 0.00 0.00 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/k g/day

SIC Code Comments: