# Support Documents for Significant New Use Rules (SNUR) on Premanufacture Notices (PMN) P-10-485

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-10-485 A-002 Standard Review Engineering Report for PMN P-10-485 A-003 Standard Review Exposure Report for PMN P-10-485 A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-10-485

# A-001 Structure Activity Team (SAT) Report for PMN P-10-485

## SAT Report PMN Number: P-10-0485 SAT Date: 8/17/2010 Print Date: 5/2/2012

Related cases : Health related cases: Ecotox related cases :
Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 1 Health: PMN ; Eco: p arent substance 2 3 Health: Incin Pdt ; Eco: high concern for toxicity of incomplete incinerati o p roducts to terrestrial organisms
Persistence Bioaccum Toxicity Comments 3 1 1 PMN 3 2 2 Incin Pdt

Exposure Based Review : Health: N o Ecotox: N o Routes of exposure : Health: Drinking Water Inhalation Ecotox: N o releases to water Fate: ; Keywords : Keywords: LUNG
Inc Incin Pdt: LIVER BLOOD MALE REPRO IMMUNO ONCO AQUATOX-A,C Summary of Assessment :
Fate :

### Fate Summary: P-10-0485 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 (%) = 90 via sorption Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = v.strong PBT Potential: PMN P3B1; incin Pdt P3B2 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is nil all routes, based on physical/chemical p roperties. There is concern for lung toxicity if inhaled, based on lung overload for high molecular weight and possible waterproofing of lung membranes. For the potential incomplete incineration product, based on test data for the analog concerns are liver toxicity, blood toxicity, and male reproductive toxicity [rat 28-day oral N OAEL = 50 mg/kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral LOAEL = 10 mg/kg based on decreased body weight in males at all doses and liver toxicity and anemia at 200 mg/kg; there were toxic effects on the testes in 2 males in the 90-day oral study that were judged by the reviewer to be indicative of the potential for male reproductive toxicity. There is also concern for immunosuppression and oncogenicity based on data for
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 = solid with mp unk; S < 0.001 mg/L at 25 C (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 Category
Ecotox Factors Comments:
SAT Chair: J. Kwiat

# A-002 Standard Review Engineering Report for PMN P-10-485

### INITIAL REVIEW ENGINEERING REPORT PMN: 10-0485 Standard Review Draft 9/7/2010 ENGINEER: El-Zoobi \ JAS PV (kg/yr):
Revision Notes / Assessment Overview: SR:

SUBMITTER:
USE:

OTHER USES:

CRSS :

Consumer Use: No SAT (concerns) (08/17/2010): Related Cases and Related Cases and Misc SAT Info:

### Heatlh Rating :1-2, Eco Rating: 1 (for PMN) // Heatlh Rating :2, Eco Rating: 3 Migration to groundwater: Negligible PBT rating: P3B2T2 P3B1T1 (PMN) // P3B2T2 (Incin Pdt) Health: 2 Drinking Water, Inhalation Eco: 3 No releases to Water
OCCUPATIONAL EXPOSURE RATING: 1B
NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW:
INITIAL REVIEW ENGINEERING REPORT PMN: 10-0485

### 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

INITIAL REVIEW ENGINEERING REPORT PMN: 10-0485

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

MEMORANDUM of CBI TELEPHONE CONVERSATION
CALL BY:

CALL TO: M. El-Zoobi

### Organization: OCSPP
Date: 09/07/2010
Time: 10
Phone:

PMN: 10-0485

# A-003 Standard Review Exposure Report for PMN P-10-485September 15, 2010



### STANDARD REVIEW EXPOSURE REPORT (IRExR) Summary – This report prepared using the standard review engineering report dated 9/7/2010. The only release estimate that chan ged in this rpoet was th There is still one exposure based crit eria met for Surface water release after treatment of Chemical ID: P-10-0485 Reviewer: Delpire/SS/Cinalli 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 = 1,000 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 7.82E-06 --- --- --- --- --- --- --- --- --- ---

PDM1 --- --- --- --- 1.30E-01 --- --- --- --- --- Max LADD --- 3.96E-08 --- --- --- --- --- --- --- --- --- Max ADR: max acute eco 1.89E-03 --- --- --- --- --- --- --- --- --- ---

PDM1 --- --- --- --- 3.87E+01 --- --- --- --- --- Max LADD --- 5.78E-05 --- --- --- --- --- --- --- --- --- 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) 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) Total Release After Treatment (kg/yr) NA No Consumer Use? NoSeptember 15, 2010



### Fate test recommendations?: (default is NA)September 15, 2010

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0485 Assessor: Delpire/SS
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Release Activity: Max ADR 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:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0485 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER:1 RELEASE ACTIVITY: Max ADR
FACILITY NAME : FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MLD) CONCENTRATION ( μ g/L) 4.12E-02 9.36E-02 0.13 0.16 NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion Units
Cancer
LADD pot 3.96E-08 mg/kg/day 0.00 mg/kg/day
LADC pot 2.03E-06 mg/L 0.00 mg/kg
Acute
ADR pot 7.82E-06 mg/kg/day 0.00 mg/kg/day

Surface Water Comments:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0485 Assessor: Delpire/SS
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: PDM1 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:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0485 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER:2 RELEASE ACTIVITY: PDM1
FACILITY NAME : FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MLD) CONCENTRATION ( μ g/L) 4.12E-02 9.36E-02 0.13 0.16 NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion Units
Cancer
LADD pot 3.96E-08 mg/kg/day 0.00 mg/kg/day
LADC pot 2.03E-06 mg/L 0.00 mg/kg
Acute
ADR pot 7.82E-06 mg/kg/day 0.00 mg/kg/day

Surface Water Comments:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P-10-0485
SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER: 2 RELEASE ACTIVITY: PDM1
FACILITY NAME : FACILITY LOCATION:
RECEIVING STREAM NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT NUMBER: GAGING STATION ID: GAGING STATION PERIOD OF RECORD: GAGING STATION NUMBER OF OBSERVATIONS: NUMBER OF STATIONS ON REACH:

50 %ile FLOW (MLD): 10 %ile FL OW (MLD): EFFLUENT FLOW (MLD)

RESULTS

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

1000.00September 15, 2010

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0485 Assessor: Delpire/SS
ENVIRONMENTAL RELEASES
Scenario#:3 Number of Release Sites: Release Activity: Max LADD 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:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0485 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER:3 RELEASE ACTIVITY: Max LADD
FACILITY NAME : FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MLD) CONCENTRATION ( μ g/L) N/A N/A N/A N/A NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion Units
Cancer
LADD pot 3.96E-08 mg/kg/day 0.00 mg/kg/day
LADC pot 2.03E-06 mg/L 0.00 mg/kg
Acute
ADR pot N/A mg/kg/day N/A mg/kg/day

Surface Water Comments:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0485 Assessor: Delpire/SS
ENVIRONMENTAL RELEASES
Scenario#:4 Number of Release Sites: Release Activity: Max ADR 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:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0485

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO #: 4 Number of Sites: RELEASE ACTIVITY Max ADR SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 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 50 288.00 123.84 78.18 66.05 1.04 2.42 3.84 4.54
ALL 10 39.60 13.29 7.76 7.57 7.58 22.57 38.66 39.63

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 7.95E-06 5.78E-05 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.08E-04 2.96E-03 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 2.02E-04 1.89E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0485 Assessor: Delpire/SS
ENVIRONMENTAL RELEASES
Scenario#:5 Number of Release Sites: Release Activity: PDM1 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:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0485

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO #: 5 Number of Site s: RELEASE ACTIVITY PDM1 SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 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 50 288.00 123.84 78.18 66.05 1.04 2.42 3.84 4.54
ALL 10 39.60 13.29 7.76 7.57 7.58 22.57 38.66 39.63

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 7.95E-06 5.78E-05 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.08E-04 2.96E-03 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 2.02E-04 1.89E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0485

SIC CODE EXPOSURES TO SURFACE WATER RELEASES
SCENARIO #: 5 RELEASE ACTIVITY: PDM1 SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)
ASSOCIATED SIC CODES: Subset of 4952
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

1000.00 HighSeptember 15, 2010

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0485 Assessor: Delpire/SS
ENVIRONMENTAL RELEASES
Scenario#:6 Number of Release Sites: Release Activity: Max LADD 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:September 15, 2010

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0485

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO #: 6 Number of Sites: RELEASE ACTIVITY: Max LADD SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 49 52 EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 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 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A
ALL 10 39.60 13.29 7.76 7.57 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 7.95E-06 5.78E-05 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.08E-04 2.96E-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:September 15, 2010

# A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-10-485