Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-333 

EPA Docket EPA-HQ-OPPT-2011-0942 

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Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-333 

A-002 Initial Review Engineering Report for 

 PMN P-11-333 

A-003 Initial Review Exposure Report for 

 PMN P-11-333 

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A-001 

Structure Activity Team (SAT) Report 

for PMN P-11-333 

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SAT Report

PMN Number: P-11-0333

SAT Date: 4/26/2011

Print Date: 8/31/2011

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 2

 Persistence Bioaccum Toxicity Comments

1 11

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: 

IRR-E,S,MM

AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-11-0333

FATE: 

Solid 

S = Negl.

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 75-90 via sorption and biodeg

Time for complete ultimate aerobic biodeg = wk-mo

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Sorption to soils/sediments = strong

PBT Potential: P1B1

*CEB FATE: Migration to ground water = slow

 Health:

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

while for the material in solution absorption of the low molecular weight fraction (36.2% <1000, 

14.6% < 500) is poor through the skin, based on physical/chemical properties. Absorption of 

the low molecular weight fraction is poor through the lung and GI tract, also based on 

physical/chemical properties. There are concerns for irritation to the eye, skin, and mucous 

membranes, based on the 

 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 0.73

fish _ chronic value >10

daphnid _ chronic value >10

algal _ chronic value 0.24

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

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

chemical class = polymer-phosphate ester; 

solid with unknown mp (P); S < 0.001 mg/L in water at 25 C (M); pH7; effective 

concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 

mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

24

SARs organic phosphates

SAR Class polymer-nonionic-phosphate 

ester

new chemicals category: none

Ecotox Factors Comments: 

 SAT Chair: J. Kwiat

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A-002 

Initial Review Engineering Report 

for PMN P-11-333 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0333

Standard Review Draft 5/31/2011

ENGINEER: Prothero \ EV

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES: 

MSDS: Label

CRSS :

Chemical Name: 

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Consumer Use: 

SAT (concerns) (04/26/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: 

Migration to groundwater: Slow

PBT rating: P1B1T1 .

Health: 1-2 Dermal, Drinking Water, Inhalation

Eco: 2 Water (All releases to water with a CC = 24 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2C

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

None.

EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0333

Manufacturing

Number of Sites/ Location: 

Days/yr: 

Basis:

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Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

Dermal:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0333

Processing

Number of Sites/ Location: 

Days/yr: 

Basis: 

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

INHALATION MONITORING DATA REVIEW

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MEMORANDUM of CBI TELEPHONE CONVERSATION

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A-003 

Initial Review Exposure Report 

 for PMN P-11-333 

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INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0333 Reviewer: Wong/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 

CC = 24 

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 

 Max ADR: max 

acute eco 

1.16E-03 --- --- --- 2.38E+01 --- --- --- --- --- --- 

 PDM1 --- --- --- --- 2.38E+01 54 --- --- --- --- --- 

 Max LADD --- 3.64E-05 --- --- --- --- 3.74E-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 daily 

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

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0333 Assessor: Wong/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 0.00 N/A N/A 

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

Non-sludge/Sludge 

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

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

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

Remarks: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0333 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY : Max 

ADR 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 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 0.64 1.49 2.37 2.80 

ALL 10 4.67 13.92 23.84 24.44 

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 5.01E-06 3.64E-05 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.57E-04 1.87E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.25E-04 1.16E-03 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0333 Assessor: Wong/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: PDM1 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 0.00 N/A N/A 

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

Non-sludge/Sludge 

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

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

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

Remarks: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0333 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY 

PDM1 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 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 0.64 1.49 2.37 2.80 

ALL 10 4.67 13.92 23.84 24.44 

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 5.01E-06 3.64E-05 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.57E-04 1.87E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.25E-04 1.16E-03 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0333 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: PDM1 

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES: 

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 

24.00 15 54 High 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0333 Assessor: Wong/JB 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: N/A N/A 

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

Non-sludge/Sludge 

Release Days/yr: N/A N/A 

Per Site Release: N/A N/A 

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

Remarks: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0333 

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY Max 

LADD 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 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 N/A N/A N/A N/A 

ALL 10 N/A N/A N/A N/A 

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 5.01E-06 3.64E-05 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.57E-04 1.87E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0333 

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES 

SCENARIO #: 3 ACTIVITY: 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 

 (%) 

 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) 3.74E-04 30.00 75.00 71.80 1.40 

LADCpot (mg/L) 1.92E-02 30.00 75.00 NA NA 

REMARKS: 

 

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