Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-10-247 

EPA Docket EPA-HQ-OPPT-2011-0577 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-10-247 

A-002 Initial Review Engineering Report for 

PMN P-10-247 

A-003 Initial Review Exposure Report for 

PMN P-10-247 

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A-001 

Structure Activity Team (SAT) Report

for PMN P-10-247 

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A-002 

Initial Review Engineering Report

for PMN P-10-247 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0247

Post-Focus Draft Revision 2 9/16/2010

ENGINEER: Macek \ BCS

PV (kg/yr): 

Revision Notes / Assessment Overview: Post-Focus Revision

#2 (September 16, 2010): The previous version of the

IRER (dated June 16, 2010) has been revised based on

additional information provided by the submitter (Letter

from George Schaefer of Ferro Corporation to 

of the USEPA). The information pertained to the

assessment of water release during manufacture.

SUBMITTER: Ferro Corporation

USE:

OTHER USES: None found.

MSDS: Yes Label: No

Gen Eqpt: no information listed

Respirator: no information listed

Health Effects: Routes of exposure: inhalation, ingestion,

 skin and eye contact. // Eye contact: avoid contact with

skin and eyes. // Inhalation: avoid breathing vapors or

mists.

TLV/PEL:

none established

CRSS :

Chemical Name:

S-H20: 0.000006 g/L @

VP: 3.0E-6 torr @

MW: 389.00 %<500 %<1000

Physical State and Misc CRSS Info:

Neat: Liquid

The MF, MW and

estimated properties above are for a 

. Submitted Data: Liquid; density = 1.0316

g/cm3; refractive index = 1.496. Estimated Data (EPI for

MF C24 H36 O4, MW = 388.55, MP entered as 20°C): BP = 418.

75°C; VP = 2.9E-06 torr; WS = 5.84E-06 g/L; log P = 7.60.

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Consumer Use: No

SAT (concerns) (03/09/2010):

Migration to groundwater: Negligible

PBT rating: P2B1T1

Health: 1-2 Dermal, Inhalation

Eco: 3 Water (All releases to water with a CC = 1 ppb)

OCCUPATIONAL EXPOSURE RATING: 2-3C

NOTES & KEY ASSUMPTIONS:

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

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POLLUTION PREVENTION CONSIDERATIONS:

None.

EXPOSURE-BASED REVIEW: 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0247

MFG: Manufacturing of PMN

Number of Sites/ Location: 

 

Days/yr: 

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. Note: SAT concern for dermal,

inhalation and releases to water with a CoC = 1 ppb.

incineration releases not expected; migration to

groundwater = negligible; water releases are expected.

Output 2: 

to:

from: 

basis: 

 

 

 

 

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Output 2: 

to: 

from: 

basis:

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

negligible (VP < 0.001 torr)

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Dermal:

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0247

PROC/USE: 

Number of Sites/ Location: 

 

 

 

 

 

Days/yr: 

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: 

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Output 2: 

to: 

from: 

basis:

Output 2: 

to: 

from:

basis:

Output 1: 

Output 2: 

to: 

from:

basis: 

 

 

 

 

 

 

Conservative: 

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: 

 

Inhalation:

Exposure to 

Upper Bound: 

Number of workers (all sites) with inhalation exposure:

Basis: 

 

INHALATION MONITORING DATA REVIEW

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1) Uncertainty (estimate based on model, regulatory limit

 or data not specific to industry): Yes

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

 OR

 b) Hazard Rating for health of 2 or greater? 1-2 No

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Liquid 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis:

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis:



CALL BY: Greg Macek

Organization: USEPA/OPPT/EETD

CALL TO: George Schaefer

Organization: Fero Corp.

Date: 06/01/2010

Time:

Phone: 216-750-6908

PMN: 10-0247

 

 

 

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A-003 

Initial Review Exposure Report

for PMN P-10-247 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0247 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 = 1 

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 

MFG: max acute eco 

MFG: PDM1 

MFG: Max LADD 

PROC/USE(A): max 

acute eco 

PROC/USE(A): 

PDM1 

PROC/USE(A): Max 

LADD 

PROC/USE(B): max 

acute eco 

PROC/USE(B): 

PDM1 

PROC/USE(B): Max 

LADD 

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: Recommended testing: OECD 308, Aerobic and anaerobic transformation in aquatic sediment 

systems. 

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Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria 

Parameter Exp Based Persistent Exceedance Value 

Drinking (Surface) Water Dose (mg/kg/day) 

Fish Ingestion Dose (mg/kg/day) 

Inhalation Dose (mg/kg/day) 

Groundwater Dose (mg/kg/day) 

Surface Water Release After Treatment (kg/yr) 

Total Release After Treatment (kg/yr) 

Consumer Use? 

Fate test recommendations?: (default is NA)

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POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: MFG: 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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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: MFG: 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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 Chemical ID: P-10-0247 

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Chemical ID: P-10-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: MFG: Max 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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 Chemical ID: P-10-0247 

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Chemical ID: P-10-0247 Assessor: Delpire/SS 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0247 

SIC Code Comments: 

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Chemical ID: P-10-0247 

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Chemical ID: P-10-0247 Assessor: Delpire/SS 

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 Chemical ID: P-10-0247 

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 Chemical ID: P-10-0247 

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Chemical ID: P-10-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:6 Number of Release Sites: 

 Release Activity: PROC/USE(A): Max 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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 Chemical ID: P-10-0247 

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Chemical ID: P-10-0247 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:7 Number of Release Sites: 

 Release Activity: PROC/USE(B): 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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Chemical ID: P-10-0247 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:8 Number of Release Sites: 

 Release Activity: PROC/USE(B): 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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 Chemical ID: P-10-0247 

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Chemical ID: P-10-0247 Assessor: Delpire/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:9 Number of Release Sites: 

 Release Activity: PROC/USE(B): Max 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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