Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-479 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

EPA SANITIZED Page 1 of 52
Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-479 

A-002 Initial Review Engineering Report for 

PMN P-09-479 

A-003 Initial Review Exposure Report for 

PMN P-09-479 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-09-479 

 

EPA SANITIZED Page 3 of 52
SAT Report

PMN Number: P-09-0479

SAT Date: 7/17/2009

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 3

 Persistence Bioaccum Toxicity Comments

 2 1 2 PMN

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal, inhalation

Ecotox: All releases to water

Fate: ;

P2Rec Comments:

Comment: SAT had no comment

Keywords:

 Keywords: LIVER; KIDNEY; TESTES; MALE REPRO; DEVEL; ONCO 

(UNCERT); NEURO (UNCERT); AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-09-0479

FATE: 

Solid with MP = 97.6 EC (M)

log Kow = 2.28 (M); 

S = 0.537 mg/L at 25 EC (M)

Hydrolysis half-life (ester) $mo at pH 7 

VP < 1.0E-6 torr at 25 EC (M)

BP > 400 EC (E)

H < 1.00E-8 (E)

EPA SANITIZED Page 4 of 52
log Koc = 2.91 (E)

log Fish BCF = 1.17 (E)

log Fish BAF = 0.504 (E) 

POTW removal (%) = 0; OECD 301F(Mano Resp):0%/28d; OECD 

111(Hydrolysis):t1/2(pH7,9):1357h/1522h@25C.

Time for complete ultimate aerobic biodeg = mo

Sorption to soils/sediments = moderate

PBT Potential: P2B1

*CEB FATE: Migration to ground water = moderate

 Health:

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

absorption through the skin if in solution (pchem), moderate absorption from the lung and GI 

tract (analog), expect some ester hydrolysis to release Concern for 

liver toxicity, effects to the testes, and male reproductive toxicity and uncertain concern for 

neurotoxicity based on submitted test data. Also concern for kidney toxicity. Concern for 

developmental toxicity for the acid hydrolysis product based on small substituted , 

and uncertain concern for 

oncogenicity for the substituted 

 Test Data: (-) Salmonella with and without activation; (-) for 

chromosome aberrations in V79 cells with and without activation; rat oral LD0 = 2000 mg/kg; 

rat dermal LD0 = 2000 mg/kg; no skin irritation in rabbits; slight eye irritation in rabbits; no skin 

sensitization in guinea pigs using the Magnusson-Kligman assay; rat 28-day oral (diet) NOAEL 

= 100 mg/kg, liver and testes toxicity at 1000 mg/kg; rat 28-day oral (gavage) LOAEL = 1000 

mg/kg (only dose tested in follow-up study), increased liver, kidney, and adrenal gland weight, 

decreased brain and testes weight, atrophy of testes

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 3.3 >0.36 NOEC = 0.36

daphnid 48-h LC50 0.58 >0.67 NOEC = 0.67

green algal 96-h EC50 0.50 0.06

fish _ chronic value 0.076

daphnid _ chronic value 0.030

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 414; log Kow = 4.16 (EPI), 2.28 (M); solid 

with mp 98 C and S 15 mg/L (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;

EPA SANITIZED Page 5 of 52
Three acute ecotoxicity tests were submitted with this PMN and reviewed. Conclusions are 

shown below. Complete details may be found in the accompanying spreadsheet.

Conclusion: The three tests are considered valid. The OECD Guidance document on difficult to 

test substances was consulted for these tests. The static fish test (96-h) and the static daphnid test 

(48-h) were limit tests with nominal concentrations of 100 mg/L. The measured concentrations 

at test initiation for the fish and daphnid tests were 0.51 mg/L and 0.73 mg/L, respectively. Even 

though these values were orders of magnitude lower than the nominal concentration (due to 

P09-0479's low water solubility), the concentrations were stable (0.2 mg/L and 0.6 mg/L for the 

fish and daphnids, respectively) throughout the test. Adverse effects were not reported in the 

fish or daphnid tests. The algal test was a definitive test with five concentrations. Similar to the 

fish and daphnid tests, measured concentrations at test initiation were 0.2 to 0.6% of the reported 

nominal concentrations with a minor concentration decrease throughout the test duration. 

Adverse effects were reported for algal biomass with a 72-h EC50 of 0.061 mg/L. The median 

measured concentrations were used to determine the EC50 values. The concern concentration 

(CoC) is derived from the EC50 value for the most sensitive species, algae. The EC50 value 

(0.061 mg/L) is divided by an acute to chronic ratio of 4 to determine an algal ChV of 15 ug/L. 

The CoC for PMN P09-0479 is estimated by dividing the algal ChV by an assessment factor of 

10 to yield 1.5ug/L, rounded to 2 ppb. The PMN P09-0479 is of high concern for ecotoxicity.

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

2

SARs

SAR Class

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

EPA SANITIZED Page 6 of 52
A-002 

Initial Review Engineering Report 

 for PMN P-09-479 

 

EPA SANITIZED Page 7 of 52
INITIAL REVIEW ENGINEERING REPORT

P-09-0479

Focus Ready Draft 7/23/2009

ENGINEER: Jon \ CPW

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER: Lamberti USA Inc. (submitter)

USE:

 

 

 

Consumer Use:

SAT (concerns): (7/17/2009):

Migration to groundwater:

PBT rating: P2 B1 T2

Health: 1-2, Dermal, Inhalation

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

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS:

EPA SANITIZED Page 8 of 52
Generated by the 06/07/2005 version of ChemSTEER. 

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: 

EPA SANITIZED Page 9 of 52
P-09-0479

Processing: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis:

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

EPA SANITIZED Page 10 of 52
 

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P-09-0479

Use 2: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis: 

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

EPA SANITIZED Page 13 of 52
 

EPA SANITIZED Page 14 of 52
P-09-0479

Use 1: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis: 

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

EPA SANITIZED Page 15 of 52
 

EPA SANITIZED Page 16 of 52
P-09-0479

Use 2: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis: 

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

EPA SANITIZED Page 17 of 52
 

 

EPA SANITIZED Page 18 of 52
P-09-0479

Processing: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis:

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

EPA SANITIZED Page 19 of 52
 

 

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EPA SANITIZED Page 21 of 52
P-09-0479

Use 1: 

Number of Sites/Location: 

 

Basis: 

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

EPA SANITIZED Page 22 of 52
 

Yes

EPA SANITIZED Page 23 of 52
TEST DATA REVIEW ENGINEERING REPORT

P-09-0479

Post-Focus Draft Revision 2 10/14/2010

ENGINEER: Jon \ CPW

PV (kg/yr): 

SUBMITTER: Lamberti USA Inc. (submitter)

USE:

 

 

 

Consumer Use:

SAT (concerns): (7/17/2009):

Migration to groundwater: Moderate

PBT rating: P2 B1 T2

Health: 1-2, Dermal, Inhalation

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

OCCUPATIONAL EXPOSURE RATING: 2-3B

EPA SANITIZED Page 24 of 52
NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: 

EPA SANITIZED Page 25 of 52
P-09-0479

Use 2: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis: 

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

EPA SANITIZED Page 26 of 52
 

EPA SANITIZED Page 27 of 52
P-09-0479

Processing: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis:

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

EPA SANITIZED Page 28 of 52
 

EPA SANITIZED Page 29 of 52
P-09-0479

Use 1: 

Number of Sites/Location: 1 submitter site(s) 

 

Basis: 

Process Description:

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

EPA SANITIZED Page 30 of 52
 

EPA SANITIZED Page 31 of 52
A-003 

Initial Review Exposure Report

for PMN P-09-479 

EPA SANITIZED Page 32 of 52
7/22/09 Page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090479 Reviewer: Cinalli 

 

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=3 

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, 

LADD (fugitive), 

PDM

--- --- --- --- 707.55 245 --- --- --- 1.84E-02 4.13E-04

: PDM --- --- --- --- 1.32E+04 250 --- --- --- --- --- 

: max ADR, 

LADD --- --- --- --- --- --- --- --- --- 2.76E-02 6.05E-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) 

EPA SANITIZED Page 33 of 52
7/22/09 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090479 Assessor: Cinalli 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: max ADR, LADD (fugitive), PDM 

 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: 

EPA SANITIZED Page 34 of 52
7/22/09 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090479 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY

max ADR, LADD (fugitive), PDM

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) 

 

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 5.97 17.04 27.99 33.29 

ALL 10 11.11 1.94 1.06 0.96 67.51 386.60 707.55 781.25 

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 3.19E-05 3.61E-04 mg/kg/day 2.02E-06 2.29E-05 mg/kg/day 

LADCpot 1.64E-03 1.85E-02 mg/L 2.42E-02 0.27 mg/kg 

Acute 

ADRpot 1.42E-03 3.23E-02 mg/kg/day 1.59E-04 1.80E-03 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 35 of 52
7/22/09 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090479 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 1 RELEASE ACTIVITY: max ADR, LADD (fugitive), PDM 

SIC CODE DESCRIPTION: POTW's (All facilities) 

ASSOCIATED SIC CODES: 4952 

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 

3.00 67 245 High 

Remarks: COC exceeded for > 20 days.

EPA SANITIZED Page 36 of 52
7/22/09 Page of 

INITIAL EXPOSURE REVIEW REPORT 

Chemical ID: P090479 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY max ADR, LADD (fugitive), PDM 

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): 

5.62 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

100.00 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 4.13E-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) N/A 2.25E-03 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A 1.84E-02 NA 1 day 71.80 0.55 

Inhalation Comments: 

EPA SANITIZED Page 37 of 52
7/22/09 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 38 of 52
7/22/09 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090479 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: PDM 

 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: 

EPA SANITIZED Page 39 of 52
7/22/09 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090479 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY

PDM 

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) 

 

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 22.53 111.50 318.04 522.39 621.39 

ALL 10 11.11 1.94 1.06 0.96 1260.13 7216.49 1.32E+04 1.46E+04

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 5.96E-04 6.73E-03 mg/kg/day 3.78E-05 4.27E-04 mg/kg/day 

LADCpot 3.05E-02 0.35 mg/L 0.45 5.11 mg/kg 

Acute 

ADRpot 2.66E-02 0.60 mg/kg/day 2.96E-03 3.35E-02 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 40 of 52
7/22/09 Page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P090479 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: PDM 

SIC CODE DESCRIPTION: POTW’s (All facilities) 

ASSOCIATED SIC CODES: 4952 

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 

3.00 68 250 High 

Remarks: COC exceeded for > 20 days.

EPA SANITIZED Page 41 of 52
7/22/09 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090479 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: 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: 

EPA SANITIZED Page 42 of 52
7/22/09 Page of 

INITIAL EXPOSURE REVIEW REPORT 

Chemical ID: P090479 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 3 RELEASE ACTIVITY 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): 

8.23 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

150.00 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 6.05E-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) N/A 3.29E-03 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A 2.76E-02 NA 1 day 71.80 0.55 

Inhalation Comments: 

EPA SANITIZED Page 43 of 52
7/22/09 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 44 of 52
7/22/09 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 45 of 52
October 20, 2010 page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-09-0479 Reviewer: Sherer/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 = 3 

PDM 

Days 

Exceede

d 

LADD ADR LADD ADR LADD 

Release 

activity(ies)2; 

exposure 

calculation(s)3 

mg/kg/day m g/kg/day mg/kg/day mg/kg/day μg/l # Days mg/kg/day m g/kg/day mg/kg/day m g/kg/day mg/kg/day 

Max ADR --- --- --- --- --- --- --- --- --- 2.76E-02 --- 

Max LADD --- --- --- --- --- --- --- --- --- --- 6.05E-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. 

Remarks: 

EPA SANITIZED Page 46 of 52
October 20, 2010 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-09-0479 Assessor: Sherer/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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: 

EPA SANITIZED Page 47 of 52
October 20, 2010 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-09-0479 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 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: 0.00 % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

8.23 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

150.00 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 6.05E-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) N/A 3. 29E-03 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A 2.76E-02 NA 1 day 71.80 0.55 

Inhalation Comments: 

EPA SANITIZED Page 48 of 52
October 20, 2010 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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

EPA SANITIZED Page 49 of 52
October 20, 2010 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-09-0479 Assessor: Sherer/BC 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 (k g/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: 

EPA SANITIZED Page 50 of 52
October 20, 2010 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-09-0479 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 2 RELEASE ACTIVITY Max 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): 

8.23 μg/ m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

N/A μg/m 3

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): N/A 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 6.05E-04 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) N/A 3. 29E-03 30.00 75.00 NA NA 

Acute 

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

Inhalation Comments: 

EPA SANITIZED Page 51 of 52
October 20, 2010 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 

 

 Do wnwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

EPA SANITIZED Page 52 of 52