Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-390 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-390 

A-002 Initial Review Engineering Report for 

PMN P-09-390 

A-003 Initial Review Exposure Report for 

PMN P-09-390 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-09-390 

 

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SAT Report

PMN Number: P-09-0390

SAT Date: 6/12/2009

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 1 1

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal, inhalation

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: IRR-E,S,MM,L; SENS-L; MUTA; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-09-0390

FATE: 

Solid with MP = 90 EC (M)

log Kow = 1.11 (E); 

S = 5.37 g/L at 25 EC (E)

VP = 1.6 torr at 25 EC (NOMO5)

BP = 169 EC (NOMO5) based on 112 EC @ 115 mm Hg (M)

H = 3.58E-8 (E)

log Koc = 1.46 (E)

log Fish BCF = 0.40 (E) 

POTW removal (%) = 90 via biodeg; OECD 301B (Mod Sturm CO2 Ev): 14%/28d NRB.

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments = low

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PBT Potential: P1B1

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

 Health:

 Health Summary: Not absorbed through the skin as the neat material 

(pchem), moderate absorption through the skin if in solution (analog), absorbed from the lung 

and GI tract (analog). Concern for mutagenicity (+) for chromosome 

aberrations in CHO cells with and without activation ; irritation to all tissues severe 

eye and skin irritation in rabbits ; and respiratory sensitization based on 

 Test Data: (-) Salmonella with and without activation; rat oral LD0 

= 2000 mg/kg; no skin irritation in rabbits; no eye irritation in rabbits; (-) for skin sensitization in 

a mouse local lymph node assay up to 25% ai

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 29

daphnid 48-h LC50 22 >100

green algal 96-h EC50 0.49

fish _ chronic value 0.49

daphnid _ chronic value 0.45

algal _ chronic value 0.21

Sewage Sludge 3-h EC50

Sewage Sludge _ Chronic Value _

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

chemical class = ; MW 127; log Kow = 1.11 (EPI); solid with mp = 90 C (M); 

S = 5.37 g/L in water at 20 °C (M); pH7; effective concentrations based on 100% active 

ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC 

<2.0 mg/L;

An acute daphnid test was submitted with this PMN. Evaluation details are provided on the 

accompanying spreadsheet (attached).

Conclusion: The results from the Daphnid test is considered valid. Test concentrations were 

within 95 - 96 % of nominal therefore nominal test concentrations are reported. One Daphnid 

was observed to be immobilized after 48 hours exposure but this was considered to be due to 

handling stress and/or natural causes and not due to the test material exposure. The CC is 

derived from the 48-hr EC50 value of 100 mg/L. This value is divided by an assessment 

(uncertainty) factor of 10 and then divided again by ten to simulate a chronic value. This yields a 

CC = 1 mg/L or 1,000 μg/L (ppb). However, because only an acute daphnid test was conducted 

and ECOSAR predicts that algae are significantly more sensitive, The ECOSAR predicted CC of 

21 ppb will be used for this material. The PMN substance P09-0390 is of moderate concern for 

EPA SANITIZED Page 5 of 24
ecotoxicity. 

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

21

SARs

SAR Class

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-09-390 

 

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INITIAL REVIEW ENGINEERING REPORT

P-09-0390

Focus Ready Draft 6/22/2009

ENGINEER: Hall \ CPW

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

 

 

 

SAT (concerns): (6/12/2009):

Migration to groundwater: Moderate to Rapid

PBT rating: P1 B1 T1

Health: 1-2, Dermal, Inhalation

Eco: 2, Water (All releases to water with a CC = 21 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2-3A

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NOTES & KEY ASSUMPTIONS:

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

 

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: No (0 criteria met)

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P-09-0390

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A-003 

Initial Review Exposure Report

for PMN P-09-390 

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6/19/09 Page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090390 Reviewer: Sherer 

 

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=21 

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 acute eco.; 

max ADR, LADD 

(fugitive) 

--- --- --- --- 369.69 --- --- --- --- 0.50 2.21E-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 streamflow of 

the 7 consecutive days of lowest flow within a 10 year period. 

Remarks: 

Fate test recommendations?: (default is NA) 

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6/19/09 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090390 Assessor: Sherer 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: max acute eco; max ADR, LADD 

 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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6/19/09 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090390 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY max 

acute eco; max ADR, 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) 

 

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 0.71 2.14 3.15 3.89 

ALL 10 39.55 213.22 369.69 441.50 

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 7.56E-08 4.23E-06 mg/kg/day 8.17E-10 4.56E-08 mg/kg/day 

LADCpot 3.88E-06 2.17E-04 mg/L 9.77E-06 5.46E-04 mg/kg 

Acute 

ADRpot 1.79E-04 1.78E-02 mg/kg/day 3.20E-06 1.79E-04 mg/kg/day 

SIC Code Comments: 

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6/19/09 Page of 

INITIAL EXPOSURE REVIEW REPORT 

Chemical ID: P090390 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY max acute eco; max ADR, 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: 0.00 % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

3.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

2730.00 μg/m3

Per Site Stack Release: NA kg/site/day 

Stack Release Days per Year: NA days 

% Removal via Stack Release: % 

Total Stack Release: NA 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-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) N/A 1.20E-03 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A 0.50 NA 1 day 71.80 0.55 

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6/19/09 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 

EPA SANITIZED Page 17 of 24
6/19/09 Page of 

LEGEND FOR NEW CHEMICALS EXPOSURE REPORT 

This new chemicals exposure report was prepared by the Exposure Assessment Branch (EAB) of the Economics, 

Exposure and Technology Division, Office of Pollution Prevention and Toxics, USEPA. 

The goals of these reports are to calculate conservative (protective) estimates of exposure endpoints for consumers, 

the general population, and the environment. 

For each exposure scenario to industrial releases, the following three endpoints are calculated: 

(1) maximum possible acute concentrations and doses 

(2) maximum possible chronic concentrations and doses 

(3) for water releases ≥ 20 days, the probability of exceedence of the aquatic concentration of concern 

These endpoints are identified by abbreviations on the Release Activity line, e.g., (1) max ADR, (2) max 

LADD, (3) max PDM. Depending on the release inputs, these endpoints may be calculated and presented on 

the same page or different pages. That is, a release activity ID of mfg; max ADR, max PDM, max LADD

indicates that all the exposure endpoints were calculated from common manufacturing release values; 

conversely, a release activity ID of mfg &proc; max ADR indicates that only the maximum acute exposure 

values were calculated for manufacturing and processing releases that occurred at the same site. 

For each consumer product use exposure scenario, whether exposure is to the user directly or to the general 

population/environment, the maximum exposure values are calculated and presented together. 

In addition to the exposure values above, EPA policy directs that exposure and release values be compared to 

criteria threshold values for Exposure-based and PBT Exposure-based cases. 

Exposure-based (YX) cases (those with ≥ 100,000 kg/yr production volume) 

Criteria are exceeded under the following conditions: 

 Presence in consumer product with likely exposure 

≥ 3E-3 mg/kg/d exposure via air, fish ingestion or drinking water 

≥ 10,000 kg/yr release to environment (post-treatment) 

≥ 1,000 kg/yr release to water (post-treatment) 

Persistent, Bioaccumulative, Toxic (PBT) chemicals of P2B2 rating or higher and production volume ≥ 20,000 kg/yr 

Criteria are exceeded as for YX cases, with the following differences: 

≥ 2,000 kg/yr release to environment (post-treatment) 

≥ 200 kg/yr release to water (post-treatment) 

Bolding rules in the Report: Values for endpoints above that are also health or eco concerns are bolded. 

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8/5/09 Page of 

 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P090390 Reviewer: Flessner 

 

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=21 

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 acute eco; 

max ADR, LADD 

(fugitive) 

--- --- --- --- 8.09E-03 --- --- --- --- 0.50 2.21E-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 streamflow of 

the 7 consecutive days of lowest flow within a 10 year period. 

Remarks: 

Fate test recommendations: (default is NA) 

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8/5/09 Page of 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P090390 Assessor: Flessner 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: max acute eco; max ADR, LADD 

 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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8/5/09 Page of 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P090390 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER:1 RELEASE ACTIVITY: max acute eco; max ADR, LADD 

FACILITY NAME

FACILITY LOCATION: 

RECEIVING WATER NAME: 

REACH NUMBER: FACILITY ON REACH: DISCHARGE TYPE: 

NPDES PERMIT #: 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 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 

CONCENTRATION (μg/L) 2.46E-03 6.72E-03 8.09E-03 1.04E-02 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 2.63E-10 mg/kg/day 2.84E-12 mg/kg/day 

LADCpot 1.35E-08 mg/L 3.40E-08 mg/kg 

Acute 

ADRpot 5.62E-07 mg/kg/day 1.11E-08 mg/kg/day 

Surface Water Comments: 

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8/5/09 Page of 

POST FOCUS EXPOSURE REPORT 

Chemical ID: P090390 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY : max acute eco; max ADR, 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: 0.00 % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

3.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

2730.00 μg/m3

Per Site Stack Release: NA kg/site/day 

Stack Release Days per Year: NA days 

% Removal via Stack Release: % 

Total Stack Release: NA 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-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) N/A 1.20E-03 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A 0.50 NA 1 day 71.80 0.55 

Inhalation Comments: 

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8/5/09 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 

EPA SANITIZED Page 23 of 24
8/5/09 Page of 

LEGEND FOR NEW CHEMICALS EXPOSURE REPORT 

This new chemicals exposure report was prepared by the Exposure Assessment Branch (EAB) of the Economics, 

Exposure and Technology Division, Office of Pollution Prevention and Toxics, USEPA. 

The goals of these reports are to calculate conservative (protective) estimates of exposure endpoints for consumers, 

the general population, and the environment. 

For each exposure scenario to industrial releases, the following three endpoints are calculated: 

(1) maximum possible acute concentrations and doses 

(2) maximum possible chronic concentrations and doses 

(3) for water releases ≥ 20 days, the probability of exceedence of the aquatic concentration of concern 

These endpoints are identified by abbreviations on the Release Activity line, e.g., (1) max ADR, (2) max 

LADD, (3) max PDM. Depending on the release inputs, these endpoints may be calculated and presented on 

the same page or different pages. That is, a release activity ID of mfg; max ADR, max PDM, max LADD

indicates that all the exposure endpoints were calculated from common manufacturing release values; 

conversely, a release activity ID of mfg &proc; max ADR indicates that only the maximum acute exposure 

values were calculated for manufacturing and processing releases that occurred at the same site. 

For each consumer product use exposure scenario, whether exposure is to the user directly or to the general 

population/environment, the maximum exposure values are calculated and presented together. 

In addition to the exposure values above, EPA policy directs that exposure and release values be compared to 

criteria threshold values for Exposure-based and PBT Exposure-based cases. 

Exposure-based (YX) cases (those with ≥ 100,000 kg/yr production volume) 

Criteria are exceeded under the following conditions: 

 Presence in consumer product with likely exposure 

≥ 3E-3 mg/kg/d exposure via air, fish ingestion or drinking water 

≥ 10,000 kg/yr release to environment (post-treatment) 

≥ 1,000 kg/yr release to water (post-treatment) 

Persistent, Bioaccumulative, Toxic (PBT) chemicals of P2B2 rating or higher and production volume ≥ 20,000 kg/yr 

Criteria are exceeded as for YX cases, with the following differences: 

≥ 2,000 kg/yr release to environment (post-treatment) 

≥ 200 kg/yr release to water (post-treatment) 

Bolding rules in the Report: Values for endpoints above that are also health or eco concerns are bolded. 

EPA SANITIZED Page 24 of 24