# Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-09-613

EPA Docket EPA

- HQ

- OPPT -2011-0577

# Index

A-001 Structure Activity Team (SAT) Report for

PMN P-09-613

A-002 Initial Review Engineering Report for

PMN P-09-613

A-003 Initial Review Exposure Report for

PMN P-09-613

# A-001

Structure Activity Team (SAT) Report

for PMN P-09-613

# A-002

Initial Review Engineering Report

for PMN P-09-613

# A-003

Initial Review Exposure Report

for PMN P-09-613

### POST FOCUS REVIEW EXPO SURE REPORT (IRExR) 

# Updated Exposure Report based on

Engineering Report dated 02/03/10 (corrected 04/14/10)

Chemical ID: P090613 Reviewer: Flessner/Cinalli

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air

Release activity(ies) 2 ;

exposure

calculation(s) 3 Drinking Water Fish Ingestion 7Q10 4

CC=? PDM

Days

Exceeded LADD ADR LADD ADR LADD ADR LADD ADR LADD

mg/kg/day mg/kg/day mg/kg/day mg/kg/day μ g/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day

Mfg/Proc: max ADR

--- --- --- --- --- --- --- 3.68e-02 --- --- ---

Mfg/Proc: max LADD --- --- --- --- --- --- 2.08e-04 1.35e-03 --- --- ---

Use: max LADD --- --- --- --- --- --- 1.41e-04 --- --- --- ---

1 

### Exposure scenario titles consist of release activ ity followed by exposure calculation abbreviation.

2 

### Release activities are from engineering report's Manufactur ing (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 (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 streamflow of

the 7 consecutive days of lowest flow within a 10 year period.

Remarks: Updated Exposure Report based on Engineering Report dated 02/03/10

All water releases removed

Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria

Parameter Exp Based Persistent Exceedance Value

Drinking (Surface) Wate r Dose (mg/kg/day)

Fish Ingestion Dose (mg/kg/day)

Inhalation Dose (mg/kg/day)

Groundwater Dose (mg/kg/day)

Surface Water Release After Treatment (kg/yr)

Total Release After Treatment (kg/yr)

Consumer Use?



### Fate test recommendations?: (default is NA)

### POST FOCUS REVIEW EXPOSURE REPORT

Chemical ID: P090613 Assessor: Cinalli

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites:

Release Activity: Mfg/Proc: 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: 0.00 0.00/0.00 30.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:

### POST FOCUS EXPOSURE REVIEW REPORT

Chemical ID: P090613

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 1 RELEASE AC TIVITY:Mfg/Proc: max ADR

RELEASE DESCRIPTION:

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites:

Per Site Fugitive Release: NA kg/site/day

Fugitive Release Days per Year: NA days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: NA kg/yr

Max Annual Average Air Concentration

(Fugitive): 0.00 μg/m 3



### Max 24 Hour Average Air

Concentration(Fugitive): 0.00 μg/m 3



### Per Site Stack Release: 30.00 kg/site/day

Stack Release Days per Year: days

% Removal via Stack Release: 0.00 %

Total Stack Release: kg/yr

Max Annual Average Air Concen tration (Stack): 12.80 μg/m 3



### Max 24 Hour Average Air Concentration (Stack): 200.00 μg/m 3



### Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED

(years) AT

(years) BW

(kg) Inh. Rate

(m 3 

### /hr)

Cancer

LADD pot 

### (mg/kg/day) 9.41E-04 N/A 30.00 75.00 71.80 0.55

LADC pot 

### (mg/m 3 

### ) 5.12E-03 N/A 30.00 75.00 NA NA

Acute

ADR pot



### (mg/kg/day) 3.68E-02 N/A NA 1 day 71.80 0.55

Inhalation Comments:

### Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: N/A

Inside Stack

Diameter: 0.10 m Length of Release

Opening: N/A

Stack Gas Exit

Velocity: 0.10 m/sec Width of Release

Opening: N/A

Stack Gas

Temperature: 293.00 K

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

### POST FOCUS REVIEW EXPOSURE REPORT

Chemical ID: P090613 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites:

Release Activity: Mfg/Proc: 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: 0.00 999.00/0.00 4956.60 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:

### POST FOCUS EXPOSURE REVIEW REPORT

Chemical ID: P090613

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 2 ACTIVITY: Mfg/Proc: 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

(%)

999.00/ 0.00 Slow 90.00 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

Exposure Units Results ASSUMPTIONS

ED

(years) AT

(years) BW

(kg) IR

(L/day)

Cancer

LADD pot 

### (mg/kg/day) 2.08E-04 30.00 75.00 71.80 1.40

LADC pot 

### (mg/L) 1.07E-02 30.00 75.00 NA NA

REMARKS:

### POST FOCUS EXPOSURE REVIEW REPORT

Chemical ID: P090613

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 2 RELEASE ACTI VITY:Mfg/Proc: max LADD

RELEASE DESCRIPTION:

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites:

Per Site Fugitive Release: NA kg/site/day

Fugitive Release Days per Year: NA days

% Removal via Fugitive Release: 0.00 %

Total Fugitive Release: NA kg/yr

Max Annual Average Air Concentration

(Fugitive): 0.00 μg/m 3



### Max 24 Hour Average Air

Concentration(Fugitive): 0.00 μg/m 3



### Per Site Stack Release: 4956.60 kg/site/day

Stack Release Days per Year: days

% Removal via Stack Release: 0.00 %

Total Stack Release: kg/yr

Max Annual Average Air Concen tration (Stack): 18.30 μg/m 3



### Max 24 Hour Average Air Concentration (Stack): μg/m 3



### Exposure Units Results

(Stack) Results

(Fugitive) ASSUMPTIONS

ED

(years) AT

(years) BW

(kg) Inh. Rate

(m 3 

### /hr)

Cancer

LADD pot 

### (mg/kg/day) 1.35E-03 N/A 30.00 75.00 71.80 0.55

LADC pot 

### (mg/m 3 

### ) 7.32E-03 N/A 30.00 75.00 NA NA

Inhalation Comments:

### Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: N/A

Inside Stack

Diameter: 0.10 m Length of Release

Opening: N/A

Stack Gas Exit

Velocity: 0.10 m/sec Width of Release

Opening: N/A

Stack Gas

Temperature: 293.00 K

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

### POST FOCUS REVIEW EXPOSURE REPORT

Chemical ID: P090613 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites:

Release Activity: Use: 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: 0.00 675.00/0.00 0.00 0.00

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:

### POST FOCUS EXPOSURE REVIEW REPORT

Chemical ID: P090613

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 3 ACTIVITY: Use: 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

(%)

675.00/ 0.00 Slow 90.00 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

Exposure Units Results ASSUMPTIONS

ED

(years) AT

(years) BW

(kg) IR

(L/day)

Cancer

LADD pot 

### (mg/kg/day) 1.41E-04 30.00 75.00 71.80 1.40

LADC pot 

### (mg/L) 7.21E-03 30.00 75.00 NA NA

REMARKS:

# LEGEND FOR NEW CHEMICAL S EXPOSURE REPORT

This new chemicals exposure report wa s prepared by the Exposure Assessment Branch (EAB) of the Economics,

Exposure and Technology Division, Office of Pollution Prevention and Toxics, USEPA.

The goals of these reports are to calcula te conservative (protective) estimates of exposure endpoints for consumers,

the general population, and the environment.

For each exposure scenario to industrial releases, the following three endpoints are calculated:

(1) maximum possible acute concentrations and doses

(2) maximum possible chronic concentrations and doses

(3) for water releases ≥ 20 days, the probability of exceedence of the aquatic concentration of concern

These endpoints are identified by abbreviati ons on the Release Activity line, e.g., (1) max ADR , (2) max

LADD , (3) max PDM . Depending on the release inputs, these e ndpoints may be calculated and presented on

the same page or different pages. That is, a release activity ID of mfg; max ADR, max PDM, max LADD

indicates that all the exposure endpoints were cal culated from common manufacturing release values;

conversely, a release activity ID of mfg &proc; max ADR indicates that only the maximum acute exposure

values were calculated for manufacturing and proce ssing releases that occurred at the same site.

For each consumer product use exposure scenario, whether exposure is to the user directly or to the general

population/environment, the maximum exposure values are calculated and presented together.

In addition to the exposure values above, EPA policy dir ects that exposure and release values be compared to

criteria threshold values for Exposure-based and PBT Exposure-based cases.

Exposure-based (YX) cases (those with ≥ 100,000 kg/yr production volume)

Criteria are exceeded under the following conditions:

Presence in consumer product with likely exposure

≥ 3E-3 mg/kg/d exposure via air, fish ingestion or drinking water

≥ 10,000 kg/yr release to environment (post-treatment)

≥ 1,000 kg/yr release to water (post-treatment)

Persistent, Bioaccumulative, Toxic (PBT) chemical s of P2B2 rating or hi gher and production volume ≥ 20,000 kg/yr

Criteria are exceeded as for YX cases, with the following differences:

≥ 2,000 kg/yr release to environment (post-treatment)

≥ 200 kg/yr release to water (post-treatment)

Bolding rules in the Report: Values for endpoints above th at are also health or eco concerns are bolded.