Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-12-35 

EPA Docket EPA-HQ-OPPT-2012-0450 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-12-35 

A-002 Standard Review Engineering Report for 

 PMN P-12-35 

A-003 Standard Review Exposure Report for 

 PMN P-12-35 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-12-35 

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SAT Report

PMN Number: P-12-0035

SAT Date: 11/15/2011

Print Date: 4/6/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 1

 Persistence Bioaccum Toxicity Comments

1 1 1 Anion

3 1 1 Cation

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: No releases to water

Fate: ; Anion slow; Cation negl

Keywords:

 Keywords: 

MECH IRR-S,L

LUNG

ASTHMA

UNCERT MUTA/NEURO

Summary of Assessment:

 Fate:

Fate Summary: P-12-0035

FATE: Estimations for

log Kow = -1.64 (M)

log Koc = 1.0 (E)

log Fish BCF = 0.50 (E)

log Fish BAF = -0.049 (E)

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S = Disp. (E)

H < 1.00E-8 (E)

POTW removal (%) = Anion 90 via biodeg; Cation 90 via sorption

Time for complete ultimate aerobic biodeg = Anion da-wk; Cation >mo

Sorption to soils/sediments = Anion low; Cation v.strong

PBT Potential: Anion P1B1; Cation P3B1

*CEB FATE: Migration to ground water = Anion slow; Cation negl

 Health:

 Health Summary: For the nanosized fraction of the PMN (approximately 

40% < 100 nm), absorption is poor all routes, based on analogs. There is concern for lung 

toxicity if inhaled based on lung overload for poorly soluble particles. There also is concern for 

mechanical irritation to the skin and lung, and for possible asthma symptoms. There is also 

uncertain concern for mutagenicity based on and and neurotoxicity for 

 to the extent they are bioavailable.

 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 

 MW > 100,000; solid with mp 

unknown (P); S = dispersible in water at 25 C (P); pH7; effective concentrations based on 

100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; 

and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1000

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SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat

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A-002 

Standard Review Engineering Report 

 for PMN P-12-35 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0035

Focus Ready Draft 11/28/2011

ENGINEER: Arnold \ AH

PV (kg/yr): 

SUBMITTER: 

USE: 

OTHER USES:

 

 

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Consumer Use: No

SAT (concerns) (11/15/2011):

Related Cases and Related Cases and Misc SAT Info:

Migration to groundwater = Anion slow, Cation negl.

Migration to groundwater: Slow

PBT rating: P3B1T1 Anion: P1B1T1, Cation: P3B1T1.

Health: 1-2 Dermal, Drinking Water, Inhalation

Eco: 1 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 2B

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. 

 

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POLLUTION PREVENTION CONSIDERATIONS:

None.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0035

Number of Sites/ Location: 

Days/yr:

Basis:

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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 12-0035

Number of Sites/ Location: 

Days/yr: 

Basis:

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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

Tot. # of workers exposed via assessed routes: 

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A-003 

Standard Review Exposure Report 

 for PMN P-12-35 

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STANDARD REVIEW EXPOSURE REPORT 

This updated assessment was based on Standard Review Draft dated 12/2/2011. 

 Chemical ID: P-12-0035 Reviewer: Tobias/SS 

 

 

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

Exposure Scenario1 Water Landfill Stack Air Fugitive Air 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 7Q104 

CC = 1 

PDM 

Days 

Exceede

d 

LADD ADR LADD ADR LADD 

Release 

activity(ies)2; 

exposure 

calculation(s)3 

mg/kg/day m g/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day m g/kg/day mg/kg/day m g/kg/day mg/kg/day 

Max ADR, 

Max LADD 

--- --- --- --- --- --- --- 1.18E-03 7. 12E-05 --- --- 

 Max ADR, 

Max LADD 

--- --- --- --- --- --- 1.30E-05 2. 48E-03 5.97E-06 --- --- 

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 daily 

streamflow of the seven consecutive days of lowest flow within a ten year period. 

Remarks: 

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

Parameter Exp Based Persistent Exceedance Value 

Drinking (Surface) Water 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) NA 

Total Release After Treatment (kg/yr) NA 

Consumer Use? NA 

Fate test recommendations?: (default is NA)

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 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P120035 Assessor: Tobias/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Max ADR, Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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: 

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STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P120035 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY: Max ADR, Max LADD 

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): 

0.00 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 μg/ m3

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 Concentration (Stack): 0.97 μg/m3

Max 24 Hour Average Air Concentration (Stack): 6.44 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 7.12E-05 N/A 30 .00 75.00 71.80 0.55 

LADCpot (mg/m3) 3.87E-04 N/ A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 1.18E-03 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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P120035 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Max ADR, Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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: 

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STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P120035 

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES 

SCENARIO #: 2 ACTIVITY: Max ADR, 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 

 (%) 

 Rapid 0.00 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)

 Negl igible 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 

 

ASSUMPTIONS 

 Exposure Units Results ED 

(years) 

AT 

(years) 

BW 

(kg) 

IR 

 (L/day) 

Cancer 

LADDpot (mg/kg/day) 1.30E-05 30.00 75 .00 71.80 1.40 

LADCpot (mg/L) 6.64E-04 30.00 75.00 NA NA 

REMARKS: 

 

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STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P120035 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 2 RELEASE ACTIVITY : Max ADR, Max LADD 

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): 

0.00 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 μg/ m3

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 Concentration (Stack): 8.12E-02 μg/m3

Max 24 Hour Average Air Concentration (Stack): 13.50 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.97E-06 N/A 30 .00 75.00 71.80 0.55 

LADCpot (mg/m3) 3.25E-05 N/ A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 2.48E-03 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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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