Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-338 

EPA Docket EPA-HQ-OPPT-2012-0182 

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Index 

A-001 Structure Activity Team (SAT) Report for

 PMN P-11-338 

A-002 Initial Review Engineering Report for 

 PMN P-11-338 

A-003 Initial Review Exposure Report for 

 PMN P-11-338 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-338 

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SAT Report

PMN Number: P-11-0338

SAT Date: 5/6/2011

Print Date: 1/4/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1 3

 Persistence Bioaccum Toxicity Comments

2 11

Exposure Based Review:

Health: No

Ecotox: Yes

Routes of exposure: Health: No exposures needed

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: 

Summary of Assessment:

 Fate:

Fate Summary: P-11-0338

FATE: 

log Kow = 3.89 (E) 

S = 26.5 mg/L at 25 C (E)

VP < 1.0E-6 torr at 25 C (E)

BP > 400 C (E)

H < 1.00E-8 (E)

log Koc = 3.74 (E)

log Fish BCF = 1.65 (E)

log Fish BAF = 2.24 (E) 

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POTW removal (%) = 25 via sorption and biodeg

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = moderate - strong

PBT Potential: P2B1

*CEB FATE: Migration to ground water = slow - moderate

 Health:

 

the skin 

.

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 4.0

daphnid 48-h LC50 0.59

green algal 96-h EC50 0.47

fish _ chronic value 0.080

daphnid _ chronic 

value

0.024

algal _ chronic 

value

0.11

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for ; SAR 

chemical class = ; MW 309; log Kow = 3.89 (EPI); 

S = 26.5 mg/L 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)

2

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-11-338 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0338 

Post-Focus Draft Revision 1 10/20/2011 

ENGINEER: Macek \ EV 

PV (kg/yr): 

REVISION NOTES/ASSESSMENT OVERVIEW: 

The FOCUS ready draft version of the IRER dated 5/12/11 

was modified to incorporate additional information provided 

by the submitter. 

Additional Information 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

CEB Note: 

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SUBMITTER: 

USE: 

 

OTHER USES: 

MSDS: No Label: No 

TLV/PEL: 

No MSDS provided. 

CRSS : 

 

 

 

 

 

Consumer Use: No 

SAT (concerns) (05/06/2011): 

Related Cases and Related Cases and Misc SAT Info: 

Ecotox Related Cases: 

Migration to groundwater: Slow to moderate 

PBT rating: P2B1T1 . 

Health: 1 Drinking Water 

Eco: 3 Water (All releases to water with a CC = 2 ppb.) 

OCCUPATIONAL EXPOSURE RATING: 2C 

NOTES & KEY ASSUMPTIONS: 

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

 

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POLLUTION PREVENTION CONSIDERATIONS: 

EXPOSURE-BASED REVIEW: No 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0338 

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. 

Release Source #1

 

Release Source #2

 sites 

 

Magnitude of Release: 

 

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Media of Release: 

 

 

 

 

 

 

 

 

 

 

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Release Source #3

Release Source #4

 

 

 

 

 

 

 

Release Source #5

 s 

RELEASE TOTAL 

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY 

 

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A-003 

Initial Review Exposure Report 

 for PMN P-11-338 

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11/18/2011 Page of 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0338 Reviewer: Kwon/BC 

 

 

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 = 

2 

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

USE: Max 

LADD 

--- --- --- --- --- --- 1.74E-05 --- --- --- --- 

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: 

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11/18/2011 Page of 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-11-0338 Assessor: Kwon/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 16. 

 Release Activity: USE: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: N/A 599.04 N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: N/A 1.00/0.00 N/A N/A 

Per Site Release: N/A 37.44/0.00 N/A N/A 

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

Remarks: 

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11/18/2011 Page of 

POST FOCUS EXPOSURE REPORT 

Chemical ID: P-11-0338 

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES 

SCENARIO #: 1 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 

 (%) 

16. 37.44/1.00 0.00/0.00 Moderate 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)

 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 

 

ASSUMPTIONS 

 Exposure Units Results ED 

(years) 

AT 

(years) 

BW 

(kg) 

IR 

 (L/day) 

Cancer 

LADDpot (mg/kg/day) 1.74E-05 30.00 75.00 71.80 1.40 

LADCpot (mg/L) 8.91E-04 30.00 75.00 NA NA 

REMARKS: 

 

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