Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-10-405 

EPA Docket EPA-HQ-OPPT-2012-0450 

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Index 

A-001 Structure Activity Team (SAT) Report for 

PMN P-10-405 

A-002 Standard Review Engineering Report for 

 PMN P-10-405 

A-003 Standard Review Exposure Report for 

 PMN P-10-405 

A-004 TSCA Section 5(e) Consent Order and 

Determinations Supporting Consent Order for 

PMN P-10-405

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-10-405 

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SAT Report

PMN Number: P-10-0405

SAT Date: 6/8/2010

Print Date: 5/8/2012

Related cases:

Health related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 2 Health: PMN ; Eco: 

2 3 Health: Potential degradation product ; Eco: toxicity of incomplete

incineration products to terrestrial organisms

 Persistence Bioaccum Toxicity Comments

1 1 1 PMN

3 1 2 Degrad Pdt

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: LUNG, IRR-E,S,MM,L, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-10-0405

FATE: 

Solid with MP = Dec. 200 C (M)

S = Dispersible (ICB)

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 50 via sorption and possible partial biodeg

Time for complete ultimate aerobic biodeg > mo

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Sorption to soils/sediments = moderate - strong

PBT Potential: PMN P1B1; Degrad Pdt P3B1

*CEB FATE: Migration to ground water = slow

 Health:

 Health Summary: Absorption is nil through the skin based on 

physical/chemical properties and poor through the GI tract and moderate through the lungs based 

on analogs. There is concern for irritation to skin, eyes, lungs, mucous membranes and lung 

toxicity if inhaled based on the suractant properties of the PMN material. Low moderate 

concern. 

For the potential incomplete incineration product, based on test data for the analogue 

concerns are liver toxicity, blood toxicity, and male reproductive toxicity 

[rat 28-day oral NOAEL = 50 mg/kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral 

LOAEL = 10 mg/kg based on decreased body weight in males at all doses and liver toxicity and 

anemia at 200 mg/kg; there were toxic effects on the testes in 2 males in the 90-day oral study 

that were judged by the reviewer to be indicative of the potential for male reproductive toxicity. 

There is also concern for immunosuppression and oncogenicity based on data for 

 Test Data: TOXICITY DATA for , multiple chain length 

of 

rat acute oral study - no deaths or toxic signs at 5.4 g/kg

moderate and transient eye irritation in rabbits

slight and transient skin irritation in rabbits

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 >6.3

daphnid 48-h LC50 >3.1

green algal 96-h EC50 >1.7

fish _ chronic value ≥1.0

daphnid _ chronic 

value

≥0.50

algal _ chronic 

value

>0.63

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SAR-nearest analog analysis for 

; SAR chemical class = 

pH7; effective concentrations based on 100% active 

ingredients and nominal concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 

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mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

50

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

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A-002 

Standard Review Engineering Report 

for PMN P-10-405 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0405

Standard Review Draft 1/18/2012

ENGINEER: El-Zoobi \ EV/CM

PV (kg/yr): 

Revision Notes / Assessment Overview: =====> Revised SR

Draft dated 1-18-12: the SR Draft dated 9-15-11 was

revised by 

SUBMITTER: 

USE:

OTHER USES: 

 

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CRSS :

SAT (concerns) (06/08/2010):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases -- 

Migration to groundwater: Slow

PBT rating: P3B1T2 PMN -- P1B1T1, Degradation Product --

P3B1T2

Health: 1-2 Dermal, Inhalation

Eco: 2 Water (All releases to water with a CC = 50 ppb)

OCCUPATIONAL EXPOSURE RATING: 1-2D

NOTES & KEY ASSUMPTIONS:

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

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POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0405

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0405

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0405

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

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MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: EV

Organization: ERG

CALL TO: 

Organization: 

Date: 06/09/2010

Time: 4:00 PM

Phone: 

PMN: 10-0405

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A-003 

Standard Review Exposure Reports 

for PMN P-10-405 

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9/21/11 page of 

STANDARD REVIEW EXPOSURE REPORT 

Updated assessment based on Standard Review Draft, dated 9/15/2011. 

 Chemical ID: P-10-0405 Reviewer: Kwon/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 = 50 

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 

 PDM1 --- --- --- --- 1.15E+00 --- --- --- --- --- 

max acute eco --- --- --- --- 4.86E+03 --- --- --- --- 2.50E-01 --- 

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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9/21/11 page of 

 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-10-0405 Assessor: Kwon/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: PDM1 

 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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9/21/11 page of 

STANDARD REVIEW EXPOSURE REPORT 

 Chemical ID: P-10-0405 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER:1 RELEASE ACTIVITY: : PDM1 

FACILITY NAME: 

FACILITY LOCATION: 

RECEIVING WATER NAME: 

REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct 

NPDES PERMIT #: EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 0.00 0.00 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 

CONCENTRATION (μg/L) 0.43 0.81 1.15 1.43 NA 

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water 

Results 

Drinking Water 

Units 

Fish Ingestion 

Results 

Fish Ingestion 

Units 

Cancer 

LADDpot 4.65E-07 mg/kg/day 0.00 mg/kg/day 

LADCpot 2.38E-05 mg/L 0.00 mg/kg 

Acute 

ADRpot 6.80E-05 mg/kg/day 0.00 mg/kg/day 

Surface Water Comments: 

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STANDARD REVIEW EXPOSURE REPORT 

 Chemical ID: P-10-0405 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER: 1 RELEASE ACTIVITY: PDM1 

FACILITY NAME: 

FACILITY LOCATION:

RECEIVING STREAM NAME: 

REACH NUMBER: FACILITY ON REACH: Yes DISCHARGE TYPE: Direct 

NPDES PERMIT NUMBER: GAGING STATION ID: 

GAGING STATION 

PERIOD OF RECORD: 

GAGING STATION 

NUMBER OF 

OBSERVATIONS: 

NUMBER OF STATIONS ON 

REACH: 

MEAN FLOW (MLD): 7q10 FLOW (MLD): EFFLUENT FLOW (MLD):

 

RESULTS 

COC (μg/L) 

Percent of Year 

COC Exceeded 

Number of Days 

COC Exceeded 

Release 

days/year 

Pre-treatment 

Loading 

(kg/site/day) 

Waste Water 

Treatment (%) 

50.00 

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 STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-10-0405 Assessor: Kwon/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: 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: 

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

Remarks: 

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STANDARD REVIEW EXPOSURE REPORT 

 Chemical ID: P-10-0405 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY Max 

ADR 

SIC-CODE DESCRIPTION: POTW's (All facilities) 

SIC-CODE (S): 4952 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 0.00 0.00 

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 50 125.56 44.02 26.80 22.53 41.06 117.11 192.35 228.81 

ALL 10 11.11 1.94 1.06 0.96 464.00 2657.22 4863.21 5369.79 

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 8.77E-07 9.91E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 4.50E-05 5.08E-04 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 9.79E-03 0.22 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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9/21/11 page of 

STANDARD REVIEW EXPOSURE REPORT 

Chemical ID: P-10-0405 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 2 RELEASE ACTIVITY Max ADR 

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): 

0.30 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

1370.00 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): 0.00 μg/m3

Max 24 Hour Average Air Concentration (Stack): 0.00 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) N/A 2.21E-05 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) N/A 1.20E-04 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A 0.25 NA 1 day 71.80 0.55 

Inhalation Comments: 

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9/21/11 page of 

 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 Release Height: 3.00 m 

Inside Stack 

Diameter: 

0.10 Length of Release 

Opening: 

10.00 m 

Stack Gas Exit 

Velocity: 

0.10 Width of Release 

Opening: 

10.00 m 

Stack Gas 

Temperature: 

293.00 

 

 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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A-004 

TSCA Section 5(e) Consent Order 

 and Determinations Supporting Consent Order 

 for PMN P-10-405

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