EPA SANITIZED 

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Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-247 

EPA Docket EPA-HQ-OPPT-2012-0450 
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-247 

A-002 Initial Review Engineering Report for 

 PMN P-11-247 

A-003 Initial Review Exposure Report for 

 PMN P-11-247 

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

Determinations Supporting Consent Order for 

PMN P-11-247

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-247 

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SAT Report

PMN Number: P-11-0247

SAT Date: 3/18/2011

Print Date: 5/2/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 1 Health: PMN Substance ; Eco: intact material

2 3 Health: ; Eco: incomplete incineration products

 Persistence Bioaccum Toxicity Comments

3 1 1 PMN

3 2 2 Incin Pdt

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Inhalation ; DW and Inhalaiton for incineration 

product

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: PMN: LUNG OVERLOAD

LIVER; BLOOD; MALE REPRO; IMMUNOTOX; ONCO; 

AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-11-0247

FATE: 

Solid 

S = Negl.

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

BP > 400 C (E)

H < 1.00E-8 (E)

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POTW removal (%) = 90 via sorption

Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = v.strong

PBT Potential: PMN P3B1; Incin Pdt P3B2

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes (pchem). Concern for lung 

toxicity if inhaled based on lung overload for high molecular weight polymers for the intact 

PMN substance. For the potential incomplete incineration product, based on test data for the 

concerns are liver toxicity, blood toxicity, and male reproductive toxicity 

[rat 28-day oral NOAEL = 50 mg/kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral 

LOAEL = 10 mg/kg based on decreased body weight in males at all doses and liver toxicity and 

anemia at 200 mg/kg; there were toxic effects on the testes in 2 males in the 90-day oral study 

that were judged by the reviewer to be indicative of the potential for male reproductive toxicity. 

There is also concern for immunosuppression and oncogenicity based on data for 

 Test Data: (-) Salmonella with and without activation; (-) E. coli 

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 nonionic polymers; SAR 

chemical class = 

 solid with mp unknown (P); S < 0.001 mg/L at 25 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;

high concern for the degradation product

Factors Values Comments

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Assessment Factor 10

Concentration of Concern 

(ppb)

*

SARs nonionic polymers

SAR Class polymer-nonionic

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-11-247 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0247

Focus Ready Draft 3/28/2011

ENGINEER: El-Zoobi \ EV

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES: 

 

CRSS :

 

Consumer Use: 

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SAT (concerns) (03/18/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: 

Migration to groundwater: Negligible

PBT rating: P3B2T2 PMN: P3B1T1, P3B2T2

Health: 2 Drinking Water, Inhalation

Eco: 3 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claims: 

EXPOSURE-BASED REVIEW: 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0247

Use 

Number of Sites/ Location: 1

unknown site(s)

Days/yr: 250

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

Low End of Range: 6.0E-3 kg/site-day over 250 days/yr from

1 site

High End of Range: 2.0E-1 kg/site-day over 250 days/yr

from 1 site

Water or Incineration or Landfill

High End: 1.2E+0 kg/site-day over 48 days/yr from 1 site

or 6.0E+1 kg/yr

Water or Incineration or Landfill

Conservative: 8.0E-2 kg/site-day over 250 days/yr from 1

site

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or 2.0E+1 kg/yr

RELEASE TOTAL

1.3E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 6

Basis:

Inhalation:

Negligible (VP < 0.001 torr). 

Dermal:

Exposure to Liquid at 20.00% concentration

Low End of Range: 1.2E+2 mg/day over 250 days/yr

High End of Range: 3.5E+2 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 6

MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: EV

Organization: ERG for EPA

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CALL TO: 

Organization: 

Date: 03/21/2011

Time: 1:20 PM

Phone: 

PMN: 11-0247

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A-003 

Initial Review Exposure Report 

 for PMN P-11-247 

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INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0247 Reviewer: Delpire/SS 

 

 

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 

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 

USE: Max ADR: 

max acute eco 

8.84E-04 --- --- --- 1.81E+01 --- --- 1.58E-03 --- --- --- 

USE: PDM1 --- --- --- --- 1.81E+01 --- --- --- --- --- 

USE: PDM2 --- --- --- --- 3.42E+00 --- --- --- --- --- 

USE: Max LADD --- 5.10E-06 --- --- --- --- --- --- 2.10E-05 --- --- 

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: 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release 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: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0247 

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

SCENARIO #: 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 0.84 1.97 3.17 3.84 

ALL 10 2.77 10.58 18.09 21.64 

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 8.60E-07 2.84E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.41E-05 1.46E-04 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.64E-04 8.84E-04 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0247 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY:USE: Max ADR 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 

Per Site Fugitive Release: kg/site/day 

Fugitive Release Days per Year: days 

% Removal via Fugitive Release: % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

0.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 μg/m3

Per Site Stack Release: kg/site/day 

Stack Release Days per Year: days 

% Removal via Stack Release: % 

Total Stack Release: kg/yr 

Max Annual Average Air Concentration (Stack): 0.23 μg/m3

Max 24 Hour Average Air Concentration (Stack): 8.62 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 1.67E-05 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 9.08E-05 N/A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 1.58E-03 N/A 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: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

N/A 

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-11-0247 Assessor: Delpire/SS 

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: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0247 

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 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 0.84 1.97 3.17 3.84 

ALL 10 2.77 10.58 18.09 21.64 

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 8.60E-07 2.84E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.41E-05 1.46E-04 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.64E-04 8.84E-04 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0247 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 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 Water 

Treatment (%) 

High/Avg 

Analysis 

1000.00 High 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: USE: PDM2 

 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-11-0247 

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY:USE: 

PDM2 

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 0.16 0.37 0.60 0.73 

ALL 10 0.52 2.00 3.42 4.09 

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 8.47E-07 2.80E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.35E-05 1.44E-04 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 3.11E-05 1.67E-04 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0247 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 3 RELEASE ACTIVITY: USE: PDM2 

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 High 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:4 Number of Release Sites: 

 Release Activity: USE: 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0247 

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

SCENARIO #: 4 Number 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 

(%) 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 1.54E-06 5.10E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 7.92E-05 2.62E-04 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-11-0247 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 4 RELEASE ACTIVITY:USE: Max LADD 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 

Per Site Fugitive Release: kg/site/day 

Fugitive Release Days per Year: days 

% Removal via Fugitive Release: % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

0.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

N/A μg/m3

Per Site Stack Release: kg/site/day 

Stack Release Days per Year: days 

% Removal via Stack Release: % 

Total Stack Release: kg/yr 

Max Annual Average Air Concentration (Stack): 0.29 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) 2.10E-05 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 1.14E-04 N/A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A N/A 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: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

N/A 

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-11-247

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