# Support Documents for Significant New Use Rules (SNUR) on Premanufacture Notices (PMN) P-11-48

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-48 A-002 Standard Review Engineering Report for PMN P-11-48 A-003 Standard Review Exposure Report for PMN P-11-48 A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-11-48

# A-001 Structure Activity Team (SAT) Report for PMN P-11-48

## SAT Report PMN Number: P-11-0048 SAT Date: 11/9/2010 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: 2 3 Health: Deg Pdt ; Eco: high concern for toxicity of imcomplete incinerati o p roducts to terrestrial organisms
Persistence Bioaccum Toxicity Comments 3 1 1 PMN 3 2 2 Deg Pdt

Exposure Based Review : Health: N o Ecotox: N o Routes of exposure : Health: Drinking Water Inhalation Ecotox: All releases to water Fate: ; PMN negl; Deg Pdt rapid

P 2 Rec Comments : Comment: N o Commen t Keywords : Keywords: UNCERT LUNG

LIVER BLOOD REPRO-M IMMUNO ONCO

### Summary of Assessment :
Fate : Fate Summary: P-11-0048 FATE: Solid S = Disp. VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = PMN 90 via sorption; Deg Pdt 0 Time for complete ultimate aerobic biodeg = PMN ≥ mo; Deg Pdt > mo Sorption to soils/sediments = PMN v.strong; Deg Pdt low PBT Potential: PMN P3B1; Deg Pdt P3B2 *CEB FATE: Migration to ground water = PMN negl; Deg Pdt rapid

Health : Health Summary: Absorption is nil all routes, based on physical/chemical p roperties. There is uncertain concern for waterproofing of the lung, based on analogs. For the degradation product, based on test data for the analogue concerns are liver toxicity, blood toxicity, and male reproductive toxicity [rat 28-day oral NOAEL = 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 >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 ; SAR chemical class =

### solid with unknown mp (P); S = dispersible in water 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; high concern for the to wild mammals and birds based on mammalian test data for mammals for

. 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-11-48

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0048 Standard Review Draft 12/21/2010 ENGINEER: Jon \ JAS PV (kg/yr):

SUBMITTER:
USE:

OTHER USES:

CRSS :

Consumer Use: SAT (concerns) (11/08/2010): Related Cases and Related Cases and Misc SAT Info: Eco Analogs:

### Migration to groundwater: PMN: negl; : rapid. PBT rating: P3B2T2 PMN: P3B1T1; : P3B2T2 Health: 2 Drinking Water, Inhalation Eco: 3 Water (All releases to water with a CC = 1000 ppb.)

OCCUPATIONAL EXPOSURE RATING: 0-1
NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS: P2 Claim:

EXPOSURE-BASED REVIEW:
INITIAL REVIEW ENGINEERING REPORT

### PMN: 11-0048

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

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0048

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

MEMORANDUM of CBI TELEPHONE CONVERSATION
CALL BY: Jason A. Sese Organization: ERG for CEB
CALL TO: Organization:
Date: 11/10/2010
Time: 11:15 am
Phone:

PMN: 11-0048

### MEMORANDUM of CBI TELEPHONE CONVERSATION CALL BY: Jay Jon Organization: EPA
CALL TO: Organization:
Date: 12/14/2010
Time:
Phone:

PMN: 11-0048

# A-003 Standard Review Exposure Report for PMN P-11-4812/29/2010 Page 1 of 13



### STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-11-0048 Reviewer: Kwon/BC

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 = 1000 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 acut e eco 1.03E-05 --- --- --- 1.70E-01 --- --- --- --- --- ---

PDM1 --- --- --- --- 1.70E-01 --- --- --- --- --- Max LADD --- 6 .02E-08 --- --- --- --- --- --- --- --- ---

Max ADR: max acut e eco 4.77E-03 --- --- --- 9.61E+01 --- --- --- --- --- ---

Max LADD --- 5 .08E-07 --- --- --- --- --- --- --- --- ---

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manufact uring (Mfg), Processing (Proc) and Use release activity labels. Multiple release activities are combined in one exposu re scenario if their releases occur at same location. 3 Exposure calculations are Acute Dose Rate (ADR), 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 7Q10 streamflow, which is defined as the average daily streamflow of the seven consecutive days of lowest flow within a ten year period.
Remarks:12/29/2010 Page 2 of 13



### Results Table: Exposure Based (X B)/Persistent (P2B2) Criteria

Parameter Exp Based Persistent Exceedance Value Drinking (Surface) Wate r Dose (mg/kg/day) NA Yes 4.77E-03 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 No Total Release After Treatment (kg/yr) NA No Consumer Use? No



### Fate test recommendations?: (default is NA)12/29/2010 Page 3 of 13

POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0048 Assessor: Kwon/BC
ENVIRONMENTAL RELEASES
Scenario#:1 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:12/29/2010 Page 4 of 13

POST FOCUS EXPOSURE REPORT
Chemical ID: P-11-0048 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) 5.42E-02 0.12 0.17 0.22 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 6.02E-08 mg/kg/day 0.00 mg/kg/day
LADC pot 3.09E-06 mg/L 0.00 mg/kg
Acute
ADR pot 1.03E-05 mg/kg/day 0.00 mg/kg/day

Surface Water Comments:12/29/2010 Page 5 of 13

POST FOCUSEXPOSURE REPORT

Chemical ID: P-11-0048 Assessor: Kwon/BC
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:12/29/2010 Page 6 of 13

POST FOCUSEXPOSURE REPORT
Chemical ID: P-11-0048 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) 5.42E-02 0.12 0.17 0.22 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 6.02E-08 mg/kg/day 0.00 mg/kg/day
LADC pot 3.09E-06 mg/L 0.00 mg/kg
Acute
ADR pot 1.03E-05 mg/kg/day 0.00 mg/kg/day

Surface Water Comments:12/29/2010 Page 7 of 13

POST FOCUS EXPOSURE REPORT Chemical ID: P-11-0048
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 (%)

1000.0012/29/2010 Page 8 of 13

POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0048 Assessor: Kwon/BC
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:12/29/2010 Page 9 of 13

POST FOCUSEXPOSURE REPORT
Chemical ID: P-11-0048 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 6.02E-08 mg/kg/day 0.00 mg/kg/day
LADC pot 3.09E-06 mg/L 0.00 mg/kg
Acute
ADR pot N/A mg/kg/day N/A mg/kg/day

Surface Water Comments:12/29/2010 Page 10 of 13

POST FOCUSEXPOSURE REPORT

Chemical ID: P-11-0048 Assessor: Kwon/BC
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:12/29/2010 Page 11 of 13

POST FOCUSEXPOSURE REPORT
Chemical ID: P-11-0048

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO #: 4 Number of Site s: 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 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 3.89 8.53 13.44 15.77
ALL 10 23.80 57.06 96.08 115.27

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 8.30E-08 5.08E-07 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.26E-06 2.61E-05 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 7.13E-04 4.77E-03 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:12/29/2010 Page 12 of 13

POST FOCUSEXPOSURE REPORT

Chemical ID: P-11-0048 Assessor: Kwon/BC
ENVIRONMENTAL RELEASES
Scenario#:5 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:12/29/2010 Page 13 of 13

POST FOCUSEXPOSURE REPORT
Chemical ID: P-11-0048

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO #: 5 Number of Site s: 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 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 8.30E-08 5.08E-07 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.26E-06 2.61E-05 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:

# A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-11-48