Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-613 

EPA Docket EPA-HQ-OPPT-2011-0577 

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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 

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A-001 

Structure Activity Team (SAT) Report

for PMN P-09-613 

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A-002 

Initial Review Engineering Report

for PMN P-09-613 

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A-003 

Initial Review Exposure Report

for PMN P-09-613 

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POST FOCUS REVIEW EXPOSURE 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 Scenario1 Water Landfill Stack Air Fugitive Air 

Release activity(ies)2; 

exposure 

calculation(s)3

Drinking Water Fish Ingestion 7Q104 

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 μg/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 activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manufacturing (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) Water 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) 

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 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: 

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POST FOCUS EXPOSURE REVIEW REPORT 

Chemical ID: P090613 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY: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/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 μg/m3

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 Concentration (Stack): 12.80 μg/m3

Max 24 Hour Average Air Concentration (Stack): 200.00 μg/m3

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) 

ASSUMPTIONS 

ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

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

LADCpot (mg/m3) 5.12E-03 N/A 30.00 75.00 NA NA 

Acute 

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

Inhalation Comments: 

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 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 

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 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: 

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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 

SLUDGE1 

AND DAYS OF 

RELEASE 

(kg/site/day)/(days)

MIGRATION 

DESCRIPTOR2

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 

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

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

REMARKS: 

 

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POST FOCUS EXPOSURE REVIEW REPORT 

Chemical ID: P090613 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 2 RELEASE ACTIVITY: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/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 μg/m3

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 Concentration (Stack): 18.30 μg/m3

Max 24 Hour Average Air Concentration (Stack): μg/m3

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) 

ASSUMPTIONS 

ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

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

LADCpot (mg/m3) 7.32E-03 N/A 30.00 75.00 NA NA 

 

Inhalation Comments: 

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 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 

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 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: 

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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 

SLUDGE1 

AND DAYS OF 

RELEASE 

(kg/site/day)/(days)

MIGRATION 

DESCRIPTOR2

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 

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

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

REMARKS: 

 

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LEGEND FOR NEW CHEMICALS EXPOSURE REPORT 

This new chemicals exposure report was 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 calculate 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 abbreviations on the Release Activity line, e.g., (1) max ADR, (2) max 

LADD, (3) max PDM. Depending on the release inputs, these endpoints 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 calculated 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 processing 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 directs 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) chemicals of P2B2 rating or higher 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 that are also health or eco concerns are bolded. 

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