Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-10-424 

EPA Docket EPA-HQ-OPPT-2011-0577 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-10-424 

A-002 Initial Review Engineering Report for 

PMN P-10-424 

A-003 Initial Review Exposure Report for 

PMN P-10-424 

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A-001 

Structure Activity Team (SAT) Report

for PMN P-10-424 

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A-002 

Initial Review Engineering Report

for PMN P-10-424 

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TEST DATA REVIEW ENGINEERING REPORT

P-10-0424

Post-Focus Draft Revision 1 12/3/2010

ENGINEER: Choudhary \ DDH

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS: No LABEL: No

CRSS: (6/28/2010):

Chemical Name: 

S-H2O: 0.0015 g/L @ 

VP: 1.0E-6 torr @ 

MW: 10000 0.0%<500 0.0%<1000

Physical State and Misc CRSS Info:

Neat: Mfg: 

Proc/Form: End Use: 

The MW depends on the particle size; the estimated MW 

above is based upon the PMN material The submitter provided the following composition 

for the PMN material: The 

submitter provided additional details on the anticipated production volume in attachment 3 to the PMN submission. 

Submitted data: density = 5.43 g/cc; Estimated data: negligible VP 

(salt); WS < 0.0015 g/L (

Consumer Use: No

SAT (concerns): (6/29/2010):

Migration to groundwater: Negligible

PBT rating: P3 B1 T1

Health: 2, Inhalation

Eco: 1, No releases to Water

OCCUPATIONAL EXPOSURE RATING: 2B

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. The technical contact was called; see contact report. // 

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POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim from Optional Pollution Prevention Information PMN page 11 of the submission: 

P2 REC:

EXPOSURE-BASED REVIEW: 

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P-10-0424

Manufacturing/Use 1: 

Number of Sites/Location: 

Basis:

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. 

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

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to: 

from: 

basis:

Output 2

to: 

from: 

basis:

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Dermal:

Exposure 

High End: 3.1E+3 mg/day 

Number of workers (all sites) with Dermal exposure:

Basis:

Inhalation:

Exposure to 

Submitter Data: 1.3E+0 mg/day 

Number of workers (all sites) with Inhalation exposure:

Basis:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): No

2) (a) Exposure level > 1 mg/day? Yes

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

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P-10-0424

Manufacturing/Use 2: 

Number of Sites/Location: 

Basis:

Process Description: 

Roll Coating operation: 

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. 

Output 2

to:

from: 

basis:

Output 2

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

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to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Dermal:

Exposure to 

High End: 

Number of workers (all sites) with Dermal exposure:

Basis:

Inhalation:

Exposure to 

Submitter Data

Number of workers (all sites) with Inhalation exposure:

Basis:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): No

2) (a) Exposure level > 1 mg/day? Yes

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

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P-10-0424

Manufacturing/Use 3: 

Number of Sites/Location: 

Basis:

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. 

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2

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to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Dermal:

Exposure to 

High End: 

Number of workers (all sites) with Dermal exposure:

Basis:

Inhalation:

Exposure to 

Submitter Data: 

Number of workers (all sites) with Inhalation exposure:

Basis:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): No

2) (a) Exposure level > 1 mg/day? Yes

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

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P-10-0424

Manufacturing/Use 3: 

Number of Sites/Location: 

Basis:

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. 

Output 2

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

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Output 2: 

to: 

from: 

basis:

Output 2

to: 

from: 

basis:

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Dermal:

Exposure to 

High End

Number of workers (all sites) with Dermal exposure:

Basis:

Inhalation:

Exposure to 

Submitter Data: 

Number of workers (all sites) with Inhalation exposure:

Basis:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): No

2) (a) Exposure level > 1 mg/day? Yes

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

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P-10-0424

Manufacturing/Use 1: 

Number of Sites/Location: 

Basis:

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. 

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

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Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from:

basis:

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Dermal:

Exposure to 

High End

Number of workers (all sites) with Dermal exposure:

Basis:

Inhalation:

Exposure to 

Submitter Data: 

Number of workers (all sites) with Inhalation exposure:

Basis:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): No

2) (a) Exposure level > 1 mg/day? Yes

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

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P-10-0424

Manufacturing/Use 2: 

Number of Sites/Location: 

Basis:

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. 

Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

Output 2

to: 

from: 

basis:

Output 2: 

to: 

from: 

basis:

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Output 2: 

to: 

from:

basis:

Destroyed

Output 2: 

to: 

from: 

basis:

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Dermal:

Exposure to 

High End: 

Number of workers (all sites) with Dermal exposure:

Basis:

Inhalation:

Exposure to 

Submitter Data: 

Number of workers (all sites) with Inhalation exposure:

Basis:

INHALATION MONITORING DATA REVIEW

1) Uncertainty (estimate based on model, regulatory limit, or data not specific to industry): No

2) (a) Exposure level > 1 mg/day? Yes

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

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A-003 

Initial Review Exposure Report

for PMN P-10-424 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0424 Reviewer: Delpire/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 = 

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 

MFG/USE2: Max 

ADR 

MFG/USE3: Max 

ADR 

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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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0424 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: MFG/USE2: 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: 

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POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0424 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0424 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: MFG/USE3: 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: 

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POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0424 

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