Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-188 

EPA Docket EPA-HQ-OPPT-2011-0942 

EPA SANITIZED Page 1 of 24
Index 

A-001 Structure Activity Team (SAT) Report for

 PMN P-11-188 

A-002 Initial Review Engineering Report for 

 PMN P-11-188 

A-003 Standard Review Exposure Report for 

 PMN P-11-188 

EPA SANITIZED Page 2 of 24
A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-188 

EPA SANITIZED Page 3 of 24
SAT Report

PMN Number: P-11-0188

SAT Date: 2/18/2011

Print Date: 11/2/2011

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2 1

 Persistence Bioaccum Toxicity Comments

3 31

Exposure Based Review:

Health: Yes Exposure based testing (health): Inhalation only

Ecotox: No

Routes of exposure: Health: Dermal Inhalation 

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: LUNG, ONCO, IMMUNO, UNCERT-MUTA

Summary of Assessment:

 Fate:

Fate Summary: P-11-0186-88

FATE: 

Solid

S < 0.001 mg/L at 25 C (E)

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 0-90 via sorption

Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = low - v.strong 

PBT Potential: P3B3

EPA SANITIZED Page 4 of 24
*CEB FATE: Migration to ground water = negl - rapid

 Health:

 Health Summary: Expect poor absorption via all routes for all material that 

is less than 100 nanometers (pchem/analog). 

 Concern for 

lung toxicity if inhaled based on lung overload for poorly soluble particulates. Also concern for 

oncogenicity and immunotoxicity based on carbon nanomaterials. Uncertain concern for 

mutagenicity. Moderate concern.

 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 ; 

SAR chemical class = ; MW > 1,000,000 solid with 

unknown mp (P); S < 0.001 mg/L at 20 °C or negligible (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;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

*

SARs

SAR Class

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

EPA SANITIZED Page 5 of 24
A-002 

Initial Review Engineering Report 

 for PMN P-11-188 

EPA SANITIZED Page 6 of 24
p110188en2.txt

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0188

Post-Focus Draft Revision 2 9/28/2011

ENGINEER: Arnold \ Prothero \ DDH

PV (kg/yr): 37,000 YX

Revision Notes / Assessment Overview:

SUBMITTER: 

USE:

 

 

 

 

 

 

 

 

Page 1

EPA SANITIZED Page 7 of 24
p110188en2.txt

MSDS: Yes Label: No

Gen Eqpt: impervious gloves/ safety glasses w/ side

shield/ long-sleeved shirt and long pants/ adequate

exhaust ventilation

Respirator: When workers are facing concentrations above

the exposure limit they must use appropriate certified

respirators in accordance with their company's

respiratory protection program, local regulations, or 29

CFR 1910.134.

Health Effects: dust from this product may cause

mechanical irritation of the skin, eyes, nose, throat,

respiratory tract, etc.

TLV/PEL:

 

CRSS :

Chemical Name:

S-H20: 0.000001 g/L @

VP: 1.0E-6 torr @

MW: %<500 %<1000

Physical State and Misc CRSS Info:

Neat: Solid Mfg: Solid: 20% PMN material attached to

glass fibers Proc/Form: Solid: 7.5% PMN material

encapsulated in prepreg or pellets End Use: Solid.

Consumer Use: No

SAT (concerns) (02/18/2011):

Migration to groundwater: negl-rapid

PBT rating: P3B3T1

Health: 2 Dermal, Inhalation, XB Testing (Testing desired)

Eco: 1 No releases to Water, XB Testing (No Testing

desired)

OCCUPATIONAL EXPOSURE RATING: 1-2B

NOTES & KEY ASSUMPTIONS:

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

 

Page 2

EPA SANITIZED Page 8 of 24
p110188en2.txt

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW: 

 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0188

Page 3

EPA SANITIZED Page 9 of 24
p110188en2.txt

Number of Sites/ Location: 

 

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

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

Page 4

EPA SANITIZED Page 10 of 24
p110188en2.txt

 

 

 

 

Dermal:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0188

Number of Sites/ Location: 

 

 Basis:

Process Description:

 

Page 5

EPA SANITIZED Page 11 of 24
p110188en2.txt

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

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

 

 

 

 

 

 

 

Page 6

EPA SANITIZED Page 12 of 24
p110188en2.txt

Dermal:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0188

Number of Sites/ Location: 

Days/yr: 

Basis: 

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

 

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

Page 7

EPA SANITIZED Page 13 of 24
p110188en2.txt

Dermal:

 



MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: 

 T

CALL TO: 

Organization: 

Date: 

Time: 

Phone: 

Concerning what TSCA CBI?

PMN: 11-0188

 

 

 

 

Page 8

EPA SANITIZED Page 14 of 24
p110188en2.txt

Organization: 

Date: 

Time: 

Phone:

 

 

 

 

 

Page 9

EPA SANITIZED Page 15 of 24
A-003 

Standard Review Exposure Report 

 for PMN P-11-188 

EPA SANITIZED Page 16 of 24
9/30/11 page of 

STANDARD REVIEW EXPOSURE REPORT 

Updated assessment based on Test Data Review Engineering Report, dated 9/28/2011. 

 Chemical ID: P-11-0188 Reviewer: Kwon/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 = 

PDM 

Days 

Exceede

d 

LADD ADR LADD ADR LADD 

Release 

activity(ies)2; 

exposure 

calculation(s)3 

mg/kg/day m g/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day m g/kg/day mg/kg/day m g/kg/day mg/kg/day 

 Max 

ADR 

--- --- --- --- --- --- --- --- --- --- 

Max 

LADD 

--- --- --- --- --- --- --- --- --- 

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) 

Fish Ingestion Dose (mg/kg/day) 

Inhalation Dose (mg/kg/day) 

Groundwater Dose (mg/kg/day) 

Surface Water Release After Treatment (kg/yr) 

Total Release After Treatment (kg/yr) 

Consumer Use? 

Fate test recommendations?: (default is NA)

EPA SANITIZED Page 17 of 24
9/30/11 page of 

 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0188 Assessor: Wong/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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 18 of 24
9/30/11 page of 

STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0188 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY 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): 

 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

 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): μg/m3

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

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 30.00 75.00 NA NA 

Acute 

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

Inhalation Comments: 

EPA SANITIZED Page 19 of 24
9/30/11 page of 

 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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

EPA SANITIZED Page 20 of 24
9/30/11 page of 

 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0188 Assessor: Wong/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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 21 of 24
9/30/11 page of 

STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0188 

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES 

SCENARIO #: 2 ACTIVITY: Max LADD 

RELEASE DESCRIPTION: 

EXPOSED POPULATION: Adult 

NUMBER 

OF 

SITES 

NON-SLUDGE 

LANDFILL 

RELEASE AND 

DAYS OF 

RELEASE 

(kg/site/day)/(days) 

 LANDFILLED 

SLUDGE1 

AND DAYS OF 

RELEASE 

(kg/site/day)/(days)

MIGRATION 

DESCRIPTOR2

ADSORPTION 

TO 

WASTEWATER 

SLUDGE 

 (%) 

DRINKING 

WATER 

TREATMENT 

 (%) 

 

 1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the surface 

 water pre-treatment release.

 

 2 Migration Descriptor Log Koc Groundwater Concentration (GWC) 

 (mg/L per kg release)

 Negl igible no migration None 

Negligible to slow > 4.5 3.21E-6 

Slow <4. 5 to 3.5 2.67E-5 

Moderate <3.5 to 2.5 5.95E-5 

Rapid <2. 5 7. 55E-5 

 

ASSUMPTIONS 

 Exposure Units Results ED 

(years) 

AT 

(years) 

BW 

(kg) 

IR 

 (L/day) 

Cancer 

LADDpot (mg/kg/day) 30.00 75.00 71.80 1.40 

LADCpot (mg/L) 30.00 75.00 NA NA 

REMARKS: 

 

EPA SANITIZED Page 22 of 24
9/30/11 page of 

STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0188 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 2 RELEASE ACTIVITY 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): 

 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

 μg/m 3

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): μg/m3

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

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 30.00 75.00 NA NA 

Acute 

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

Inhalation Comments: 

EPA SANITIZED Page 23 of 24
9/30/11 page of 

 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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

EPA SANITIZED Page 24 of 24