Documents in Support of a 

Significant New Use Rule for 

Premanufacture Notice (PMN) P-14-0209 

Docket ID Number 

EPA-HQ-OPPT-2015-0220 

EPA SANITIZED Page 1 of 20
 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 

EPA SANITIZED Page 2 of 20
 

Sanitized SAT Report for P-14-0209 

 

EPA SANITIZED Page 3 of 20
EPA SANITIZED Page 4 of 20
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 (pchem). 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 

(ppb)

1

EPA SANITIZED Page 5 of 20
SARs Amides 

SAR Class Amides 

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

EPA SANITIZED Page 6 of 20
 

Sanitized Engineering Report for P-14-0209 

 

EPA SANITIZED Page 7 of 20
EPA SANITIZED Page 8 of 20
EPA SANITIZED Page 9 of 20
EPA SANITIZED Page 10 of 20
EPA SANITIZED Page 11 of 20
EPA SANITIZED Page 12 of 20
EPA SANITIZED Page 13 of 20
EPA SANITIZED Page 14 of 20
 

Sanitized Exposure Report for P-14-0209 

EPA SANITIZED Page 15 of 20
EPA SANITIZED Page 16 of 20
3/12/14 

 STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-14-0209 Assessor: Bevington/SS

ENVIRONMENTAL RELEASES

Scenario#:1 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: 

EPA SANITIZED Page 17 of 20
3/12/14 

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-14-0209

SITE-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: 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) 4.80 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

LADDpot 3.08E-07 mg/kg/day 1.50E-08 mg/kg/day

LADCpot 1.58E-05 mg/L 1.80E-04 mg/kg

Acute

ADRpot 7.45E-04 mg/kg/day 9.83E-05 mg/kg/day

Surface Water Comments: 

EPA SANITIZED Page 18 of 20
3/12/14 

 STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-14-0209 Assessor: Bevington/SS

ENVIRONMENTAL RELEASES

Scenario#: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: 

EPA SANITIZED Page 19 of 20
3/12/14 

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-14-0209

SITE-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 REACH: 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

LADDpot 5.00E-10 mg/kg/day 2.44E-11 mg/kg/day

LADCpot 2.56E-08 mg/L 2.92E-07 mg/kg

Acute

ADRpot 1.07E-06 mg/kg/day 9.58E-08 mg/kg/day

Surface Water Comments: 

EPA SANITIZED Page 20 of 20