Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-12-182 

EPA Docket EPA-HQ-OPPT-2012-0450 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-12-182 

A-002 Initial Review Engineering Report for 

 PMN P-12-182 

A-003 Initial Review Exposure Report for 

 PMN P-12-182 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-12-182 

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SAT Report

PMN Number: P-12-0182

SAT Date: 2/28/2012

Print Date: 5/2/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 3 Health: ; Eco: significant mitigation of toxicity expected, i.e., ~43x

1-2

 Persistence Bioaccum Toxicity Comments

3 11

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: 

IRR-E,L,MM

LUNG

AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-12-0182

FATE: 

VP < 1.0E-6 torr at 25 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 90-99 via sorption

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Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = v.strong

PBT Potential: P3B1

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes, based on physical/chemical 

properties. There is concern for irritation to the eye, lung, and mucous membranes, based on 

amines, There also is concern for lung toxicity from cationic binding to lung membranes.

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.72

daphnid 48-h LC50 0.22

green algal 96-h EC50 0.053

fish _ chronic value 0.040

daphnid _ chronic 

value

0.016

algal _ chronic 

value

0.013

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for polycationic polymers with 

 SAR chemical class = polymer - cationic - ; 

; liquid (P); S > 1000 g/L at 20 C (P); pH7; effective concentrations based 

on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and 

TOC <2.0 mg/L;

significant mitigation of toxicity expected in the presence of 10 mg TOC/L; MF ~43x;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

56 with mitigation

SARs polycationic polymers

SAR Class polymer-cationicEcotox Category Polycationic Polymers

Ecotox Factors Comments: 

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 SAT Chair: J. Kwiat

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A-002 

Initial Review Engineering Report 

 for PMN P-12-182 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0182

Focus Ready Draft 3/8/2012

ENGINEER: Arnold \ JAS

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES: 

MSDS: No Label: No

TLV/PEL:

none established.

CRSS :

 

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Consumer Use: 

SAT (concerns) (02/28/2012):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: 

Migration to groundwater: Negligible

PBT rating: P3B1T1 .

Health: 1-2 Drinking Water, Inhalation

Eco: 3 Water (All releases to water with a CC = 56 ppb

with mitigation), XB Testing (Testing desired)

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. 

POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW: 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0182

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Manufacturing: 

Number of Sites/ Location: 

Days/yr: 

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below

may coincide with daily releases from the other sources

to the same medium.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0182

Use: 

Number of Sites/ Location: 

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Days/yr: 

Basis:

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below

may coincide with daily releases from the other sources

to the same medium.

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

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A-003 

Initial Review Exposure Report 

 for PMN P-12-182 

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3/7/2012 Page 1 of 5 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-12-0182 Reviewer: Flessner/SD 

 

 

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

Exposure 

Scenario1 

 Water Landfill Stack Air Fugitive Air 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 7Q104 

CC = 

56 

PDM 

Days 

Exceede

d 

LADD ADR LADD ADR LADD 

Release 

activity(ies)2; 

exposure 

calculation(s)

3 

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 

Mfg: Max 

ADR: max 

acute eco 

7.00E-01 --- --- --- 1.45E+04 --- --- --- --- --- --- 

Mfg: Max 

LADD 

--- 5.28E-04 --- --- --- --- --- --- --- --- --- 

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: 

Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria 

Parameter Exp Based Persistent Exceedance Value 

Drinking (Surface) Water Dose (mg/kg/day) No NA 

Fish Ingestion Dose (mg/kg/day) No NA 

Inhalation Dose (mg/kg/day) No NA 

Groundwater Dose (mg/kg/day) No NA 

Surface Water Release After Treatment (kg/yr) 

Total Release After Treatment (kg/yr) No NA 

Consumer Use? No 

Fate test recommendations?: (default is NA)

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-12-0182 Assessor: Flessner/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Mfg: 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-12-0182 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY:Mfg: 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 27.73 83.75 123.55 152.37 

ALL 10 1549.34 8352.88 1.45E+04 1.73E+04

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 9.48E-06 5.30E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.86E-04 2.72E-02 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 7.00E-03 0.70 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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3/7/2012 Page 4 of 5 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-12-0182 Assessor: Flessner/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Mfg: 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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3/7/2012 Page 5 of 5 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-12-0182 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY:Mfg: 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 9.45E-06 5.28E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.85E-04 2.71E-02 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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