Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-561 

EPA Docket EPA-HQ-OPPT-2012-0182 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-561 

A-002 Initial Review Engineering Report for 

 PMN P-11-561 

A-003 Initial Review Exposure Report for 

 PMN P-11-561 

A-004 TSCA Section 5(e) Consent Order and 

Determinations Supporting Consent Order for 

PMN P-11-561 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-561 

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SAT Report

PMN Number: P-11-0561

SAT Date: 8/30/2011

Print Date: 2/6/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 1

 Persistence Bioaccum Toxicity Comments

3 1 1 PMN

3 2 Inc Pdt

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Inhalation 

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: 

MECH IRR-E,S,L

LUNG

Summary of Assessment:

 Fate:

Fate Summary: P-11-0561

FATE: 

Solid with MP = 239-251 C (M)

S = Negl.

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

BP = Dec. > 413 C (M)

H < 1.00E-8 (E)

POTW removal (%) = 90 via sorption

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Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = v.strong

PBT Potential: PMN P3B1; Inc Pdt B3B2

*CEB FATE: Migration to ground water = negl

 Health:

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

properties. There is concern for mechanical irritation to the eye, skin, and lung, based on 

information in the PMN MSDS. There also is concern for lung toxicity if inhaled based on lung 

overload for 

 Test Data: Submitted with the PMN:

Salmonella assay negative with and without activation;

E. coli reverse mutation assay negative with and without activation

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

fish _ chronic value *

daphnid _ chronic 

value

*

algal _ chronic 

value

*

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for 

 

pH7; effective concentrations based on 100% 

active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC 

<2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

*

SARs

Ecotox Category 

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Ecotox Factors Comments: 

 SAT Chair: J. Kwiat

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A-002 

Initial Review Engineering Report 

 for PMN P-11-561 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0561

Focus Ready Draft 9/8/2011

ENGINEER: El-Zoobi \ CLM

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES:

 

CRSS :

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Consumer Use: No

SAT (concerns) (08/30/2011):

Migration to groundwater: Negligible

PBT rating: P3B2T1 PMN: P3B1T1 // Incin Pdt: P3B2

Health: 1-2 Dermal, Inhalation

Eco: 1 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS:

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

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POLLUTION PREVENTION CONSIDERATIONS:

None.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0561

Use: 

Number of Sites/ Location: 7

unknown sites

Days/yr: 200

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.

Water or Air or Incineration or Landfill

Output 2: 1.4E+0 kg/site-day over 200 days/yr from 7 sites

or 2.0E+3 kg/yr

Water or Incineration or Landfill

Output 2: 2.9E+0 kg/site-day over 200 days/yr from 7 sites

or 4.0E+3 kg/yr

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Water or Incineration or Landfill

Conservative: 5.7E+0 kg/site-day over 200 days/yr from 7

sites

or 8.0E+3 kg/yr

Water or Landfill

Output 2: 2.9E+0 kg/site-day over 200 days/yr from 7 sites

or 4.0E+3 kg/yr

RELEASE TOTAL

1.8E+4 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

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A-003 

Initial Review Exposure Report 

 for PMN P-11-561 

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INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0561 Reviewer: Kwon/JB 

 

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 = 

1000 

PDM 

Days 

Exceeded 

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 

Use: Max ADR: max 

acute eco 

7.86E-03 --- --- --- --- --- --- 1.24E-05 --- 3.49E-02 --- 

Use: PDM1 --- --- --- --- 1.66E+02 1 --- --- --- --- --- 

Use: Max LADD --- 1.39E-04 --- --- --- --- --- --- 5.43E-07 --- 6.16E-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) NA No 

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

Inhalation Dose (mg/kg/day) NA No 

Groundwater Dose (mg/kg/day) NA No 

Surface Water Release After Treatment (kg/yr) NA Yes 1.81E+03 

Total Release After Treatment (kg/yr) NA Yes 3.57E+03 

Consumer Use? No 

Fate test recommendations?: (default is NA) 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0561 Assessor: Kwon/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 7. 

 Release Activity: Use: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 1.81E+04 N/A 1.40E+04 1960.00 

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

Non-sludge/Sludge 

Release Days/yr: 200.00 0.00/0.00 200.00 200.00 

Per Site Release: 12.90 N/A/0.00 10.00 1.40 

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

Remarks: 

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September 7, 2011 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0561 

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

SCENARIO #: 1 Number of Sites: 7 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) 

90.00 200. 12.9 1.29 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 

ALL 10 

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 4.17E-06 1.24E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.14E-04 6.35E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.78E-04 7.86E-03 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0561 

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 

1000.00 0 2 200.00 12.90 90.00 High 

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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0561 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY:Use: Max ADR 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 7. 

Per Site Fugitive Release: 1.40 kg/site/day 

Fugitive Release Days per Year: 200.00 days 

% Removal via Fugitive Release: 0.00 % 

Total Fugitive Release: 1960.00 kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

8.38 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

190.00 μg/m3

Per Site Stack Release: 10.00 kg/site/day 

Stack Release Days per Year: 200.00 days 

% Removal via Stack Release: 99.90 % 

Total Stack Release: 1.40E+04 kg/yr 

Max Annual Average Air Concentration (Stack): 7.38E-03 μg/m3

Max 24 Hour Average Air Concentration (Stack): 6.74E-02 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.43E-07 6.16E-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 2.95E-06 3.35E-03 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 1.24E-05 3.49E-02 NA 1 day 71.80 0.55 

Inhalation Comments: 

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 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: 3.00 m 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

10.00 m 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

10.00 m 

Stack Gas 

Temperature: 

293.00 K 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0561 Assessor: Kwon/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 7. 

 Release Activity: Use: PDM1 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 1.81E+04 N/A 0.00 0.00 

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

Non-sludge/Sludge 

Release Days/yr: 200.00 0.00/0.00 0.00 0.00 

Per Site Release: 12.90 N/A/0.00 0.00 0.00 

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

Remarks: 

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September 7, 2011 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0561 

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

SCENARIO #: 2 Number of Sites: 7 RELEASE ACTIVITY:Use: 

PDM1 

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 200. 12.9 1.29 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 50 288.00 123.84 78.18 66.05 4.48 10.42 16.50 19.53 

ALL 10 39.60 13.29 7.76 7.57 32.58 97.07 166.24 170.41 

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 1.91E-05 1.39E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 9.82E-04 7.14E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 8.70E-04 8.11E-03 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0561 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: Use: PDM1 

SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

ASSOCIATED SIC CODES: Subset of 4952 

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 

1000.00 0 1 200.00 12.90 90.00 High 

EPA SANITIZED Page 22 of 61
 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0561 Assessor: Kwon/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 7. 

 Release Activity: Use: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 1.81E+04 N/A 1.40E+04 1960.00 

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

Non-sludge/Sludge 

Release Days/yr: 1.00 0.00/0.00 1.00 1.00 

Per Site Release: 2580.00 N/A/0.00 2000.00 280.00 

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

Remarks: 

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September 7, 2011 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0561 

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

SCENARIO #: 3 Number of Sites: 7 RELEASE ACTIVITY:Use: Max 

LADD 

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 1. 2580. 258.00 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 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A 

ALL 10 39.60 13.29 7.76 7.57 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 1.91E-05 1.39E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 9.82E-04 7.14E-03 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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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0561 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 3 RELEASE ACTIVITY:Use: Max LADD 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 7. 

Per Site Fugitive Release: 280.00 kg/site/day 

Fugitive Release Days per Year: 1.00 days 

% Removal via Fugitive Release: 0.00 % 

Total Fugitive Release: 1960.00 kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

8.38 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

N/A μg/m3

Per Site Stack Release: 2000.00 kg/site/day 

Stack Release Days per Year: 1.00 days 

% Removal via Stack Release: 99.90 % 

Total Stack Release: 1.40E+04 kg/yr 

Max Annual Average Air Concentration (Stack): 7.38E-03 μg/m3

Max 24 Hour Average Air Concentration (Stack): N/A μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.43E-07 6.16E-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 2.95E-06 3.35E-03 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

EPA SANITIZED Page 25 of 61
September 7, 2011 Page of 

 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: 3.00 m 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

10.00 m 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

10.00 m 

Stack Gas 

Temperature: 

293.00 K 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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A-004 

TSCA Section 5(e) Consent Order 

 and Determinations Supporting Consent Order 

 for PMN P-11-561 

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