# Documents in Support of a

Significant New Use Rule for

Premanufacture Notice (PMN) P-14-0209

Docket ID Number

EPA-HQ-OPPT-2015-0220

# Table of Contents

1. Sanitized SAT Report for P-14-0209

2. Sanitized Engineering Report for P-14-0209

3. Sanitized Exposure Report for P-14-0209

# Sanitized SAT Report for P-14-0209

### log Fish BAF = 1.51 (E) POTW removal (%) = 90 via sorption and biodeg Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = strong - v.strong

PBT Potential: P1B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Expect poor absorption via all routes ( p che m ). There is concern for lung effects if inhaled based on the properties of the PMN material and its ability to interfere with the balance of the lung tissue and thus interfere with the expansion and contraction of the lungs. The PMN material is also expected to be irritating to all exposed tissues.

Ecotox :

Test Organism Test Type Test End

Point Predicted Measured Comments

fish 96-h LC50 2 daphnid 48-h LC50 0.305
green algal 96-h EC50 0.116 Amides

fish

_ chronic value 0.014 Amides daphnid

_ chronic

value 0.032

algal

_ chronic

value 0.061

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic

Value _

Ecotox Values Comments: Predictions are based on SARs for amides and ; SAR chemical class = amide, ; MW 282; log Kow 4.2 (EPI); liquid with mp unknown (P); S = 17 mg/L (P); effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;

The submitter provided three sheets of paper from their range-finding ecotoxicity aquatic studies. The document suggested that their testing laboratory will perform full/definitive studies based on the submitted results and submit them to EPA. CCD prefers to have this case go to FOCUS and add the data from the full studies later. As a result, QSAR predictions for this PMN will be used to assess ecological hazard and risk.

Factors Values Comments

Assessment Factor 10

Concentration of Concern ( p pb) 1

### SARs Amides

SAR Class Amides Ecotox Category

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# Sanitized Engineering Report for P-14-0209

# Sanitized Exposure Report for P-14-02093/12/14

STANDARD REVIEW EXPOSURE REPORT

Chemical ID : P- 14

- 0209 Assessor: Bevington/SS

ENVIRONMENTAL RELEASES

Scenario#: 1 Number of Release Sites:

Release Activit y: 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 R elease:

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

Remarks:3/12/14

STANDARD REVIEW EXPOSURE REPORT

Chemical ID : P- 14

- 0209

SI TE

- SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER: 1 RELEASE ACTIVITY: Max ADR

FACILITY NAME:

FACILITY LOCATION:

RECEIVING WATER NAME:

REACH NUMBER: FACILITY ON REACH: DISCHARGE TYPE:

NPDES PERMIT #: EXPOSED POPULATION: A dult

WWT

REMOVAL (%) RELEASE

DAYS PRETREATMENT

RELEASE (kg/site/day) POSTTREATMENT

RELEASE (kg/site/day) DWT

(%) BCF (L/kg)

0.00 11.40

AQUATIC EXPOSURE ESTIMATES

- SURFACE WATER

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT

FLOW (MLD)

CONCENTRATION (μg/L) 4.80 8.91 12.57 15.64 NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water

Results Drinking Water

Units Fish Ingestion

Results Fish Ingestion

Units

Cancer

LADD pot 3.08E

- 07 mg/kg/day 1.50E

- 08 mg/kg/day

LADC pot 1.58E

- 05 mg/L 1.80E

- 04 mg/kg

Acute

ADR pot 7.45E

- 04 mg/kg/day 9.83E

- 05 mg/kg/day

Surface Water Comments:3/12/14

STANDARD REVIEW EXPOSURE REPORT

Chemical ID : P- 14

- 0209 Assessor: Bevington/SS

ENVIRONMENTAL RELEASES

S cenario#: 2 Number of Release Sites:

Release Activity: 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:3/12/14

STANDARD REVIEW EXPOSURE REPORT

Chemical ID : P- 14

- 0209

SI TE

- SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER: 2 RELEASE ACTIVITY: Max ADR

FACILITY NAME:

FACILITY LOCATION:

RECEIVING WATER NAME:

REACH NUMBER: FACILITY ON REA CH: DISCHARGE TYPE:

NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT

REMOVAL (%) RELEASE

DAYS PRETREATMENT

RELEASE (kg/site/day) POSTTREATMENT

RELEASE (kg/site/day) DWT

(%) BCF (L/kg)

0 .00 11.40

AQUATIC EXPOSURE ESTIMATES

- SURFACE WATER

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT

FLOW (MLD)

CONCENTRATION (μg/L) 4.68E

- 03 1.28E

- 02 1.54E

- 02 1.98E

- 02 NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water

Results Drinking Water

Units Fish Ingestion

Results Fish Ingestion

Units

Cancer

LADD pot 5.00E -10 mg/kg/day 2.44E

- 11 mg/kg/day

LADC pot 2.56E

- 08 mg/L 2.92E

- 07 mg/kg

Acute

ADR pot 1.07E

- 06 mg/kg/day 9.58E

- 08 mg/kg/day

Surface Water Comments: