# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-11-654

EPA Docket EPA-HQ-OPPT-2012-0182

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-654 A-002 Initial Review Engineering Report for PMN P-11-654 A-003 Initial Review Exposure Report for PMN P-11-654

# A-001 Structure Activity Team (SAT) Report
for PMN P-11-654

## SAT Report PMN Number: P-11-0654 SAT Date: 10/7/2011 Print Date: 1/4/2012

Related cases :

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 3 Health: ; Eco: chronic concerns only

Persistence Bioaccum Toxicity Comments 1 1 1 PMN 1 1 1 Hyd Pdt 1 1 1 Hyd Pdt

Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Dermal Drinking Water Inhalation Ecotox: All releases to water Fate: ; Hyd Pdt moderate – rapid; Hyd Pdt rapid
Keywords : Keywords: IRR, UNCERT-MUTA/DEVEL, AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-11-0654 FATE: Estimations for hydrolysis product

### Health : Health Summary: Absorption is nil through the skin as the neat material, p oor through the skin when in solution, and poor through the lungs and GI tract based on p hysical/chemical properties. Expect poor hydrolysis in the stomach. There is concern for irritation to all exposed tissues based on the and uncertain concern for mutagenicity and developmental toxicity based on the for developmental toxicity). Low 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 *

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

### Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1

SAR Class new chemicals category: none Ecotox Category

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report
for PMN P-11-654

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0654 Post-Focus Draft Revision 1 11/17/2011
ENGINEER: El-Zoobi \ BCS PV (kg/yr):
Revision Notes / Assessment Overview: Rev.(1)=====>

SUBMITTER:

USE:

OTHER USES:

### CRSS :

Consumer Use: No
SAT (concerns) (10/07/2011): Related Cases and Related Cases and Misc SAT Info: Ecotox Analogs: // Health Related Cases:

Health: 1-2 Dermal, Drinking Water, Inhalation Eco: 3 Water (All releases to water with a CC = 1 ppb; Schiff Base SAR)

OCCUPATIONAL EXPOSURE RATING: 2B

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

### POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0654

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

### OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0654

### 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:

INITIAL REVIEW ENGINEERING REPORT PMN: 11-0654

### 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 Initial Review Exposure Report
for PMN P-11-654October 21, 2011 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-11-0654 Reviewer: Sherer/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 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

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:October 21, 2011 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0654 Assessor: Sherer/JB

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity:
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:October 21, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0654

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

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY:

EX P OSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

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

ALL 10

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 mg/kg/day mg/kg/day

LADC pot mg/L mg/kg

Acute

ADR pot mg/kg/day mg/kg/day

SIC Code Comments:October 21, 2011 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0654 Assessor: Sherer/JB

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites: Release Activity:
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:October 21, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0654

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

SCENARIO #: 2 Number of S ites: RELEASE ACTIVITY:

EX P OSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

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

ALL 10

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 mg/kg/day mg/kg/day

LADC pot mg/L mg/kg

Acute

ADR pot mg/kg/day mg/kg/day

SIC Code Comments:October 21, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0654

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY:

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 AnalysisOctober 21, 2011 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0654 Assessor: Sherer/JB

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: Release Activity:
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:October 21, 2011 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0654

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

SCENARIO #: 3 Number of Site s: RELEASE ACTIVITY:

EX P OSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

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

ALL 10

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 mg/kg/day mg/kg/day

LADC pot mg/L mg/kg

Acute

ADR pot mg/kg/day mg/kg/day

SIC Code Comments: