Support Documents for 

Significant New Use Rules (SNUR) on 

Premanufacture Notices (PMN) 

P-11-48 

EPA Docket EPA-HQ-OPPT-2012-0450 

EPA SANITIZED Page 1 of 70
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-48 

A-002 Standard Review Engineering Report for 

 PMN P-11-48 

A-003 Standard Review Exposure Report for 

 PMN P-11-48 

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

Determinations Supporting Consent Order for 

PMN P-11-48

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A-001 

Structure Activity Team (SAT) Report 

for PMN P-11-48 

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SAT Report

PMN Number: P-11-0048

SAT Date: 11/9/2010

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 ; Eco: 

2 3 Health: Deg Pdt ; Eco: high concern for toxicity of imcomplete incineratio

products to terrestrial organisms

 Persistence Bioaccum Toxicity Comments

3 1 1 PMN

3 2 2 Deg Pdt

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ; PMN negl; Deg Pdt rapid

P2Rec Comments:

Comment: No Comment

Keywords:

 Keywords: 

UNCERT LUNG

LIVER

BLOOD

REPRO-M

IMMUNO

ONCO

EPA SANITIZED Page 4 of 70
Summary of Assessment:

 Fate:

Fate Summary: P-11-0048

FATE: 

Solid 

S = Disp.

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = PMN 90 via sorption; Deg Pdt 0

Time for complete ultimate aerobic biodeg = PMN ≥ mo; Deg Pdt > mo

Sorption to soils/sediments = PMN v.strong; Deg Pdt low

PBT Potential: PMN P3B1; Deg Pdt P3B2

*CEB FATE: Migration to ground water = PMN negl; Deg Pdt rapid

 Health:

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

properties. There is uncertain concern for waterproofing of the lung, based on analogs. For the 

degradation product, based on test data for the analogue 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 

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 >100

daphnid 48-h LC50 >100

green algal 96-h EC50 >100

fish _ chronic value >10

daphnid _ chronic 

value

>10

algal _ chronic 

value

>10

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for ; SAR 

chemical class = 

EPA SANITIZED Page 5 of 70
 solid with unknown mp (P); S = dispersible in water 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 to wild mammals and birds based on 

mammalian test data for mammals for .

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1000

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat

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A-002 

Standard Review Engineering Report 

for PMN P-11-48 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0048

Standard Review Draft 12/21/2010

ENGINEER: Jon \ JAS

PV (kg/yr): 

SUBMITTER: 

USE: 

OTHER USES: 

 

CRSS :

Consumer Use: 

SAT (concerns) (11/08/2010):

Related Cases and Related Cases and Misc SAT Info:

Eco Analogs: 

EPA SANITIZED Page 8 of 70
Migration to groundwater: PMN: negl; : rapid.

PBT rating: P3B2T2 PMN: P3B1T1; : P3B2T2

Health: 2 Drinking Water, Inhalation

Eco: 3 Water (All releases to water with a CC = 1000 ppb.)

OCCUPATIONAL EXPOSURE RATING: 0-1

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

EXPOSURE-BASED REVIEW: 

INITIAL REVIEW ENGINEERING REPORT 

EPA SANITIZED Page 9 of 70
PMN: 11-0048

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

EPA SANITIZED Page 10 of 70
INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0048

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.

EPA SANITIZED Page 11 of 70
OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: Jason A. Sese

Organization: ERG for CEB

CALL TO: 

Organization: 

Date: 11/10/2010

Time: 11:15 am

Phone: 

PMN: 11-0048

EPA SANITIZED Page 12 of 70
MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: Jay Jon

Organization: EPA

CALL TO: 

Organization: 

Date: 12/14/2010

Time:

Phone: 

PMN: 11-0048

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A-003 

Standard Review Exposure Report 

for PMN P-11-48 

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STANDARD REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0048 Reviewer: Kwon/BC 

 

 

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 

: Max 

ADR: max 

acute eco 

1.03E-05 --- --- --- 1.70E-01 --- --- --- --- --- --- 

PDM1 --- --- --- --- 1.70E-01 --- --- --- --- --- 

Max 

LADD 

--- 6 .02E-08 --- --- --- --- --- --- --- --- --- 

Max 

ADR: max 

acute eco 

4.77E-03 --- --- --- 9.61E+01 --- --- --- --- --- --- 

Max 

LADD 

--- 5 .08E-07 --- --- --- --- --- --- --- --- --- 

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

Parameter Exp Based Persistent Exceedance Value 

Drinking (Surface) Water Dose (mg/kg/day) NA Yes 4.77E-03 

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 No 

Total Release After Treatment (kg/yr) NA No 

Consumer Use? No 

Fate test recommendations?: (default is NA)

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-11-0048 Assessor: Kwon/BC 

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: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0048 

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: Yes DISCHARGE TYPE: Direct 

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 0.00 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 

CONCENTRATION (μg/L) 5.42E-02 0.12 0.17 0.22 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 6.02E-08 mg/kg/day 0.00 mg/kg/day 

LADCpot 3.09E-06 mg/L 0.00 mg/kg 

Acute 

ADRpot 1.03E-05 mg/kg/day 0.00 mg/kg/day 

Surface Water Comments: 

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 POST FOCUSEXPOSURE REPORT 

Chemical ID: P-11-0048 Assessor: Kwon/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: 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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POST FOCUSEXPOSURE REPORT 

 Chemical ID: P-11-0048 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER:2 RELEASE ACTIVITY: PDM1 

FACILITY NAME: 

FACILITY LOCATION:

RECEIVING WATER NAME: 

REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct 

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 0.00 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 

CONCENTRATION (μg/L) 5.42E-02 0.12 0.17 0.22 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 6.02E-08 mg/kg/day 0.00 mg/kg/day 

LADCpot 3.09E-06 mg/L 0.00 mg/kg 

Acute 

ADRpot 1.03E-05 mg/kg/day 0.00 mg/kg/day 

Surface Water Comments: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0048 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER: 2 RELEASE ACTIVITY: PDM1 

FACILITY NAME: 

FACILITY LOCATION: 

RECEIVING STREAM NAME: 

REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct 

NPDES PERMIT NUMBER: GAGING STATION ID: 

GAGING STATION 

PERIOD OF RECORD: 

GAGING STATION 

NUMBER OF 

OBSERVATIONS: 

NUMBER OF STATIONS ON 

REACH: 

50 %ile FLOW (MLD): 10 %ile FLOW (MLD): EFFLUENT FLOW (MLD)

 

RESULTS 

COC (μg/L) 

Percent of Year 

COC Exceeded 

Number of Days 

COC Exceeded 

Release 

days/year 

Pre-treatment 

Loading 

(kg/site/day) 

Waste Water 

Treatment (%) 

1000.00 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-11-0048 Assessor: Kwon/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: 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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POST FOCUSEXPOSURE REPORT 

 Chemical ID: P-11-0048 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER:3 RELEASE ACTIVITY: Max LADD 

FACILITY NAME: 

FACILITY LOCATION: 

RECEIVING WATER NAME: 

REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct 

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 0.00 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 

CONCENTRATION (μg/L) N/A N/A N/A N/A 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 6.02E-08 mg/kg/day 0.00 mg/kg/day 

LADCpot 3.09E-06 mg/L 0.00 mg/kg 

Acute 

ADRpot N/A mg/kg/day N/A mg/kg/day 

Surface Water Comments: 

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 POST FOCUSEXPOSURE REPORT 

Chemical ID: P-11-0048 Assessor: Kwon/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:4 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: 

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POST FOCUSEXPOSURE REPORT 

 Chemical ID: P-11-0048 

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

SCENARIO #: 4 Number of Sites: RELEASE ACTIVITY: 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 3.89 8.53 13.44 15.77 

ALL 10 23.80 57.06 96.08 115.27 

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 8.30E-08 5.08E-07 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.26E-06 2.61E-05 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 7.13E-04 4.77E-03 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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 POST FOCUSEXPOSURE REPORT 

Chemical ID: P-11-0048 Assessor: Kwon/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:5 Number of Release Sites: 

 Release Activity: 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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POST FOCUSEXPOSURE REPORT 

 Chemical ID: P-11-0048 

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

SCENARIO #: 5 Number of Sites: RELEASE ACTIVITY: 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 8.30E-08 5.08E-07 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.26E-06 2.61E-05 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: 

EPA SANITIZED Page 27 of 70
A-004 

TSCA Section 5(e) Consent Order 

and Determinations Supporting Consent Order 

for PMN P-11-48