# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-11-333

EPA Docket EPA-HQ-OPPT-2011-0942

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-333 A-002 Initial Review Engineering Report for PMN P-11-333 A-003 Initial Review Exposure Report for PMN P-11-333

# A-001 Structure Activity Team (SAT) Report
for PMN P-11-333

## SAT Report PMN Number: P-11-0333 SAT Date: 4/26/2011 Print Date: 8/31/2011

Related cases : Health related cases: Ecotox related cases :

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 2

Persistence Bioaccum Toxicity Comments 1 11

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: IRR-E,S,MM AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-11-0333 FATE: Solid S = N egl. VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 75-90 via sorption and biodeg Time for complete ultimate aerobic biodeg = wk-mo

### Sorption to soils/sediments = strong PBT Potential: P1B1 *CEB FATE: Migration to ground water = slow

Health : Health Summary: Absorption is nil through the skin for the neat material, while for the material in solution absorption of the low molecular weight fraction (36.2% <1000, 14.6% < 500) is poor through the skin, based on physical/chemical properties. Absorption of the low molecular weight fraction is poor through the lung and GI tract, also based on p hysical/chemical properties. There are concerns for irritation to the eye, skin, and mucous membranes, based on the

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 0.73 fish

_ chronic value >10 daphnid

_ chronic value >10 algal

_ chronic value 0.24 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for organic phosphate; SAR chemical class = p olyme r

- p hosphate ester; solid with unknown mp (P); S < 0.001 mg/L in water at 25 C (M); 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) 24

SARs organic phosphates SAR Class p olyme r -nonionic- p hosphate ester new chemicals category: none

Ecotox Factors Comments:

SAT Chair: J. Kwiat

# A-002 Initial Review Engineering Report
for PMN P-11-333

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0333 Standard Review Draft 5/31/2011
ENGINEER: Prothero \ EV PV (kg/yr):

SUBMITTER:

USE:

OTHER USES:

MSDS: Label

CRSS : Chemical Name:

### Consumer Use:

SAT (concerns) (04/26/2011): Related Cases and Related Cases and Misc SAT Info: Ecotox Related Cases: Migration to groundwater: Slow PBT rating: P1B1T1 . Health: 1-2 Dermal, Drinking Water, Inhalation Eco: 2 Water (All releases to water with a CC = 24 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2C

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: 11-0333
Manufacturing

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:

Dermal:

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0333
Processing

Number of Sites/ Location:
Days/yr: Basis:

### OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:

Inhalation:

INHALATION MONITORING DATA REVIEW

### MEMORANDUM of CBI TELEPHONE CONVERSATION

# A-003 Initial Review Exposure Report
for PMN P-11-3334/29/2011 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR)
Chemical ID: P-11-0333 Reviewer: Wong/JB

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 = 24 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 1.16E-03 --- --- --- 2.38E+01 --- --- --- --- --- ---

PDM1 --- --- --- --- 2.38E+01 54 --- --- --- --- --- Max LADD --- 3.64E-05 --- --- --- --- 3.74E-04 --- --- --- ---

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.4/29/2011 page of

INITIAL REVI EW EXPOSURE REPORT

Chemical ID: P-11-0333 Assessor: Wong/JB

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: Max ADR
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 0. 00 N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 0.00/0.00 N/A N/A

Per Site Release: 0. 00/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:4/29/2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0333

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

SCENARIO #: 1 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

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10

ALL 50 0.64 1.49 2.37 2.80

ALL 10 4.67 13.92 23.84 24.44

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%

Cancer

LADD pot 5.01E-06 3.64E-05 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 2.57E-04 1.87E-03 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 1.25E-04 1.16E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:4/29/2011 page of

INITIAL REVI EW EXPOSURE REPORT

Chemical ID: P-11-0333 Assessor: Wong/JB

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites: Release Activity: PDM1
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: 0. 00 N/A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: 0.00/0.00 N/A N/A

Per Site Release: 0. 00/0.00 N/A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:4/29/2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0333

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

SCENARIO #: 2 Number of Site s: RELEASE ACTIVITY 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

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic Mean 30Q5 7Q10 1Q10

ALL 50 0.64 1.49 2.37 2.80

ALL 10 4.67 13.92 23.84 24.44

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%

Cancer

LADD pot 5.01E-06 3.64E-05 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 2.57E-04 1.87E-03 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 1.25E-04 1.16E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:4/29/2011 page of

INITIAL REV IEW EX POSURE REPORT

Chemical ID: P-11-0333

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY: PDM1

SIC CODE DESCRIPTION:

ASSOCIATED SIC CODES:

SIC CODE RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Loading (kg/site/day) Waste Water Treatment (%) High/Avg Analysis

24.00 15 54 High4/29/2011 page of

INITIAL REVI EW EXPOSURE REPORT

Chemical ID: P-11-0333 Assessor: Wong/JB

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: Release Activity: Max LADD
Release Description: WATER LANDFILL Non-sludge/Sludge STACK FUGITIVE

Total Releases: N/ A N/A (kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge Release Days/yr: N/A N/A

Per Site Release: N/ A N/A (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:4/29/2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0333

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

SCENARIO #: 3 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

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT TYPE % ILE FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/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 IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion

Units 50% 10% 50% 10%

Cancer

LADD pot 5.01E-06 3.64E-05 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 2.57E-04 1.87E-03 mg/L 0.00 0.00 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments:4/29/2011 page of

INITIA L REVIEW EX POSURE REPORT Chemical ID: P-11-0333

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 3 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 (%)

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) Negligible 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) 3.74E-04 30.00 75.00 71.80 1.40 LADC pot (mg/L) 1.92E-02 30.00 75.00 NA NA

REMARKS: