# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN) P-12-35

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-12-35 A-002 Standard Review Engineering Report for PMN P-12-35 A-003 Standard Review Exposure Report for PMN P-12-35

# A-001 Structure Activity Team (SAT) Report for PMN P-12-35

## SAT Report PMN Number: P-12-0035 SAT Date: 11/15/2011

Print Date: 4/6/2012
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 1 1 1 Anion 3 1 1 Cation

Exposure Based Review : Health: N o Ecotox: N o Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: N o releases to water Fate: ; Anion slow; Cation negl Keywords : Keywords: MECH IRR-S,L LUNG ASTHMA UNCERT MUTA/ N EURO Summary of Assessment : Fate : Fate Summary: P-12-0035 FATE: Estimations for log Kow = -1.64 (M) log Koc = 1.0 (E) log Fish BCF = 0.50 (E) log Fish BAF = -0.049 (E)

### S = Disp. (E)

H < 1.00E-8 (E) POTW removal (%) = Anion 90 via biodeg ; Cation 90 via sorption Time for complete ultimate aerobic biodeg = Anion da-wk; Cation >mo Sorption to soils/sediments = Anion low; Cation v.strong PBT Potential: Anion P1B1; Cation P3B1 *CEB FATE: Migration to ground water = Anion slow; Cation negl
Health : Health Summary: For the nanosized fraction of the PMN (approximately 40% < 100 nm), absorption is poor all routes, based on analogs. There is concern for lung toxicity if inhaled based on lung overload for poorly soluble particles. There also is concern for mechanical irritation to the skin and lung, and for possible asthma symptoms. There is also uncertain concern for mutagenicity based on and and neurotoxicity for to the extent they are bioavailable.
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 MW > 100,000; solid with mp unknown (P); S = dispersible in water at 25 C (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1000

### SARs SAR Class Ecotox Category
Ecotox Factors Comments:
SAT Chair: J. Kwiat

# A-002 Standard Review Engineering Report for PMN P-12-35

### INITIAL REVIEW ENGINEERING REPORT PMN: 12-0035 Focus Ready Draft 11/28/2011 ENGINEER: Arnold \ AH PV (kg/yr):

SUBMITTER:
USE:
OTHER USES:

### Consumer Use: No SAT (concerns) (11/15/2011): Related Cases and Related Cases and Misc SAT Info: Migration to groundwater = Anion slow, Cation negl. Migration to groundwater: Slow PBT rating: P3B1T1 Anion: P1B1T1, Cation: P3B1T1. Health: 1-2 Dermal, Drinking Water, Inhalation Eco: 1 No releases to Water
OCCUPATIONAL EXPOSURE RATING: 2B
NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

### POLLUTION PREVENTION CONSIDERATIONS: None.

EXPOSURE-BASED REVIEW: No
INITIAL REVIEW ENGINEERING REPORT PMN: 12-0035

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:

INITIAL REVIEW ENGINEERING REPORT PMN: 12-0035

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:

# A-003 Standard Review Exposure Report for PMN P-12-352/3/12 page of



### STANDARD REVIEW EXPOSURE REPORT This updated assessment was based on Standard Review Draft dated 12/2/2011.
Chemical ID: P-12-0035 Reviewer: Tobias/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 = 1 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 --- --- --- --- --- --- --- 1.18E-03 7. 12E-05 --- ---
Max ADR, Max LADD --- --- --- --- --- --- 1.30E-05 2. 48E-03 5.97E-06 --- ---

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). Th ere 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) 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 Total Release After Treatment (kg/yr) NA Consumer Use? NA 

### Fate test recommendations?: (default is NA)2/3/12 page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P120035 Assessor: Tobias/SS
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: Max ADR, 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:2/3/12 page of

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P120035
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 1 RELEASE ACTIVI TY: Max ADR, 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/ m 3

Max 24 Hour Average Air Concentration(Fugitive): 0.00 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 Con centration (Stack): 0.97 μg/m 3 Max 24 Hour Average Air Concentration (Stack): 6.44 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) 7.12E-05 N/A 30 .00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 3.87E-04 N/ A 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 1.18E-03 N/A NA 1 day 71.80 0.55

Inhalation Comments:2/3/12 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 m2/3/12 page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P120035 Assessor:
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: Max ADR, 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:2/3/12 page of

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P120035

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES
SCENARIO #: 2 ACTIVITY: Max ADR, 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 (%)

Rapid 0.00 0.00

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) 1.30E-05 30.00 75 .00 71.80 1.40 LADC pot (mg/L) 6.64E-04 30.00 75.00 NA NA

REMARKS:2/3/12 page of

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P120035
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 2 RELEASE ACTIVITY : Max ADR, 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/ m 3

Max 24 Hour Average Air Concentration(Fugitive): 0.00 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): 8.12E-02 μg/m 3 Max 24 Hour Average Air Concentration (Stack): 13.50 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) 5.97E-06 N/A 30 .00 75.00 71.80 0.55 LADC pot (mg/m 3 ) 3.25E-05 N/ A 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 2.48E-03 N/A NA 1 day 71.80 0.55

Inhalation Comments:2/3/12 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