# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN) P-10-405

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-10-405 A-002 Standard Review Engineering Report for PMN P-10-405 A-003 Standard Review Exposure Report for PMN P-10-405 A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-10-405

# A-001 Structure Activity Team (SAT) Report for PMN P-10-405

## SAT Report PMN Number: P-10-0405 SAT Date: 6/8/2010 Print Date: 5/8/2012
Related cases : Health related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 2 Health: PMN ; Eco: 2 3 Health: Potential degradation product ; Eco: toxicity of incomplet e incineration products to terrestrial organisms
Persistence Bioaccum Toxicity Comments 1 1 1 PMN 3 1 2 Degrad Pdt

Exposure Based Review : Health: N o Ecotox: N o Routes of exposure : Health: Dermal Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: LUNG, IRR-E,S,MM,L, AQUATOX-A,C Summary of Assessment : Fate : Fate Summary: P-10-0405 FATE: Solid with MP = Dec. 200 C (M) S = Dispersible (ICB) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) POTW removal (%) = 50 via sorption and possible partial biodeg Time for complete ultimate aerobic biodeg > mo

### Sorption to soils/sediments = moderate - strong PBT Potential: PMN P1B1; Degrad Pdt P3B1 *CEB FATE: Migration to ground water = slow
Health : Health Summary: Absorption is nil through the skin based on p hysical/chemical properties and poor through the GI tract and moderate through the lungs based on analogs. There is concern for irritation to skin, eyes, lungs, mucous membranes and lung toxicity if inhaled based on the suractant properties of the PMN material. Low moderate
concern. For the potential incomplete incineration 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
Test Data: TOXICITY DATA for , multiple chain length of rat acute oral study - no deaths or toxic signs at 5.4 g/kg moderate and transient eye irritation in rabbits slight and transient skin irritation in rabbits
Ecotox : Test Organism Test Type Test End Point Predicted Measured Comments
fish 96-h LC50 >6.3 daphnid 48-h LC50 >3.1 green algal 96-h EC50 >1.7 fish

_ chronic value ≥ 1.0 daphnid

_ chronic value ≥ 0.50 algal

_ chronic value >0.63 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _

Ecotox Values Comments: Predictions are based on SAR-nearest analog analysis for ; SAR chemical class = p H7; effective concentrations based on 100% active ingredients and nominal 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) 50

SARs SAR Class Ecotox Category
Ecotox Factors Comments: SAT Chair: Becky Jones

# A-002 Standard Review Engineering Report for PMN P-10-405

### INITIAL REVIEW ENGINEERING REPORT PMN: 10-0405 Standard Review Draft 1/18/2012 ENGINEER: El-Zoobi \ EV/CM PV (kg/yr):
Revision Notes / Assessment Overview: =====> Revised SR Draft dated 1-18-12: the SR Draft dated 9-15-11 was revised by

SUBMITTER:
USE:

OTHER USES:

### CRSS :

SAT (concerns) (06/08/2010): Related Cases and Related Cases and Misc SAT Info: Ecotox Related Cases -- Migration to groundwater: Slow PBT rating: P3B1T2 PMN -- P1B1T1, Degradation Product -- P3B1T2 Health: 1-2 Dermal, Inhalation Eco: 2 Water (All releases to water with a CC = 50 ppb)
OCCUPATIONAL EXPOSURE RATING: 1-2D
NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

### POLLUTION PREVENTION CONSIDERATIONS: P2 Claim:

EXPOSURE-BASED REVIEW: No
INITIAL REVIEW ENGINEERING REPORT PMN: 10-0405

### INITIAL REVIEW ENGINEERING REPORT PMN: 10-0405

### INITIAL REVIEW ENGINEERING REPORT PMN: 10-0405

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: EV Organization: ERG
CALL TO: Organization:
Date: 06/09/2010
Time: 4:00 PM
Phone:

PMN: 10-0405

# A-003 Standard Review Exposure Reports for PMN P-10-4059/21/11 page of



### STANDARD REVIEW EXPOSURE REPORT Updated assessment based on Standard Review Draft, dated 9/15/2011.
Chemical ID: P-10-0405 Reviewer: Kwon/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 = 50 PDM Days Exceede d 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

PDM1 --- --- --- --- 1.15E+00 --- --- --- --- --- max acute eco --- --- --- --- 4.86E+03 --- --- --- --- 2.50E-01 ---

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:9/21/11 page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0405 Assessor: Kwon/SS
ENVIRONMENTAL RELEASES
Scenario#:1 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:9/21/11 page of

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0405 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER:1 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) 0.43 0.81 1.15 1.43 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 4.65E-07 mg/kg/day 0.00 mg/kg/day
LADC pot 2.38E-05 mg/L 0.00 mg/kg
Acute
ADR pot 6.80E-05 mg/kg/day 0.00 mg/kg/day

Surface Water Comments:9/21/11 page of

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P-10-0405
SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER: 1 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:
MEAN FLOW (MLD): 7q10 FLOW (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 (%)

50.009/21/11 page of

STANDARD REVIEW EXPOSURE REPORT

Chemical ID: P-10-0405 Assessor: Kwon/SS
ENVIRONMENTAL RELEASES
Scenario#:2 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:9/21/11 page of

STANDARD REVIEW EXPOSURE REPORT
Chemical ID: P-10-0405
SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY Max ADR SIC-CODE DESCRIPTION: POTW's (All facilities) SIC-CODE (S): 4952 EX POSED 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 50 125.56 44.02 26.80 22.53 41.06 117.11 192.35 228.81
ALL 10 11.11 1.94 1.06 0.96 464.00 2657.22 4863.21 5369.79

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 8.77E-07 9.91E-06 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 4.50E-05 5.08E-04 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 9.79E-03 0.22 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:9/21/11 page of

STANDARD REVIEW EXPOSURE REPORT Chemical ID: P-10-0405
INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)
SCENARIO #: 2 RELEASE ACTIVITY Max ADR 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): 0.30 μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): 1370.00 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): 0.00 μg/m 3 Max 24 Hour Average Air Concentration (Stack): 0.00 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) N/A 2.21E-05 30.00 75.00 71.80 0.55 LADC pot (mg/m 3 ) N/A 1.20E-04 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) N/A 0.25 NA 1 day 71.80 0.55

Inhalation Comments:9/21/11 page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 Release Height: 3.00 m
Inside Stack Diameter: 0.10 Length of Release Opening: 10.00 m

Stack Gas Exit Velocity: 0.10 Width of Release Opening: 10.00 m

Stack Gas Temperature: 293.00

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

Downwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m

# A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-10-405