Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-654 

EPA Docket EPA-HQ-OPPT-2012-0182 

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Index 

A-001 Structure Activity Team (SAT) Report for

 PMN P-11-654 

A-002 Initial Review Engineering Report for 

 PMN P-11-654 

A-003 Initial Review Exposure Report for 

 PMN P-11-654 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-654 

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SAT Report

PMN Number: P-11-0654

SAT Date: 10/7/2011

Print Date: 1/4/2012

Related cases:

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3 Health: ; Eco: chronic concerns only

 Persistence Bioaccum Toxicity Comments

1 1 1 PMN

1 1 1 Hyd Pdt 

1 1 1 Hyd Pdt 

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ; Hyd Pdt moderate – rapid; 

 Hyd Pdt rapid

Keywords:

 Keywords: IRR, UNCERT-MUTA/DEVEL, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-11-0654

FATE: Estimations for hydrolysis product 

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 Health:

 Health Summary: Absorption is nil through the skin as the neat material, 

poor through the skin when in solution, and poor through the lungs and GI tract based on 

physical/chemical properties. Expect poor hydrolysis in the stomach. There is concern for 

irritation to all exposed tissues based on the and uncertain concern for 

mutagenicity and developmental toxicity based on the 

for developmental toxicity). Low moderate concern. 

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

 

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Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

1

SAR Class new chemicals category: none

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-11-654 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0654

Post-Focus Draft Revision 1 11/17/2011

ENGINEER: El-Zoobi \ BCS

PV (kg/yr): 

Revision Notes / Assessment Overview: Rev.(1)=====> 

SUBMITTER: 

USE:

OTHER USES: 

 

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CRSS :

Consumer Use: No

SAT (concerns) (10/07/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Analogs: //

Health Related Cases: 

Health: 1-2 Dermal, Drinking Water, Inhalation

Eco: 3 Water (All releases to water with a CC = 1 ppb;

Schiff Base SAR)

OCCUPATIONAL EXPOSURE RATING: 2B

NOTES & KEY ASSUMPTIONS:

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

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POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0654

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0654

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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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

 

 

 

 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0654

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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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

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A-003 

Initial Review Exposure Report 

 for PMN P-11-654 

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October 21, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0654 Reviewer: Sherer/JB 

 

 

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 PDM 

Days 

Exceeded 

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 

 

 

 

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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October 21, 2011 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0654 Assessor: Sherer/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: 

 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: 

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October 21, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0654 

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY:

EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 

ALL 10 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot mg/kg/day mg/kg/day 

LADCpot mg/L mg/kg 

Acute 

ADRpot mg/kg/day mg/kg/day 

SIC Code Comments: 

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October 21, 2011 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0654 Assessor: Sherer/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: 

 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: 

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October 21, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0654 

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY: 

EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 

ALL 10 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot mg/kg/day mg/kg/day 

LADCpot mg/L mg/kg 

Acute 

ADRpot mg/kg/day mg/kg/day 

SIC Code Comments: 

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October 21, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0654 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: 

SIC CODE RESULTS 

COC (μg/L) 

Percent of 

Year COC 

Exceeded 

Number of 

Days COC 

Exceeded 

Release 

days/year 

Loading 

(kg/site/day) 

Waste Water 

Treatment (%) 

High/Avg 

Analysis 

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October 21, 2011 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0654 Assessor: Sherer/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: 

 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: 

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October 21, 2011 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0654 

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY:

EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 

ALL 10 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot mg/kg/day mg/kg/day 

LADCpot mg/L mg/kg 

Acute 

ADRpot mg/kg/day mg/kg/day 

SIC Code Comments: 

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