# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN) P-11-188

EPA Docket EPA-HQ-OPPT-2011-0942

# 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

# A-001 Structure Activity Team (SAT) Report for PMN P-11-188

## 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: N o Routes of exposure : Health: Dermal Inhalation Ecotox: N o 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

### *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 ( p che m /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); p H7; 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 ( p pb) *

SARs SAR Class
Ecotox Factors Comments:
SAT Chair: Becky Jones

# A-002 Initial Review Engineering Report for PMN P-11-188p110188en2.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 1p110188en2.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 2p110188en2.txt

POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW:

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0188 Page 3p110188en2.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 4p110188en2.txt

Dermal:

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0188

Number of Sites/ Location:

Basis:
Process Description:

Page 5p110188en2.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 6p110188en2.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 7p110188en2.txt Dermal:



MEMORANDUM of CBI TELEPHONE CONVERSATION
CALL BY: T
CALL TO: Organization:

Date: Time: Phone: Concerning what TSCA CBI? PMN: 11-0188

Page 8p110188en2.txt Organization:

Date: Time: Phone:

Page 9

# A-003 Standard Review Exposure Report for PMN P-11-1889/30/11 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 Scenario 1 Water Landfill Stack Air Fugitive Air Drinking Water Fish Ingestion ADR LADD ADR LADD 7Q10 4 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 Manuf acturing (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 (A DR), 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 7Q 10 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 (X B)/Persistent (P2B2) Criteria

Parameter Exp Based Persistent Exceedance Value Drinking (Surface) Wate r 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)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:9/30/11 page of

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P-11-0188
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 1 RELEASE AC TIVITY 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/ m 3

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 Concen tration (Stack): μg/m 3 Max 24 Hour Average Air Concentration (Stack): μg/m 3

ASSUMPTIONS Exposure Units Results (Stack) Results (Fugitive) ED (years) AT (years) BW (kg) Inh. Rate (m 3 /hr)
Cancer
LADD pot (mg/kg/day) 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) 30.00 75.00 NA NA
Acute
ADR pot

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

Inhalation Comments: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 m9/30/11 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: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 SLUDGE 1 AND DAYS OF RELEASE (kg/site/day)/(days) MIGRATION DESCRIPTOR 2 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 LADD pot (mg/kg/day) 30.00 75.00 71.80 1.40 LADC pot (mg/L) 30.00 75.00 NA NA

REMARKS:9/30/11 page of

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P-11-0188
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 2 RELEASE ACTI VITY 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/ m 3

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 Concen tration (Stack): μg/m 3 Max 24 Hour Average Air Concentration (Stack): μg/m 3

ASSUMPTIONS Exposure Units Results (Stack) Results (Fugitive) ED (years) AT (years) BW (kg) Inh. Rate (m 3 /hr)
Cancer
LADD pot (mg/kg/day) 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) 30.00 75.00 NA NA
Acute
ADR pot

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

Inhalation Comments: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