# Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-10-247

EPA Docket EPA

- HQ

- OPPT -2011-0577

# 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

# A-001

Structure Activity Team (SAT) Report

for PMN P-10-247

# A-002

Initial Review En gineering Report

for PMN P-10-247Support - P-10-0247 engineering.2.txt

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.

Page 1Support - P-10-0247 engineering.2.txt

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.

Page 2Support - P-10-0247 engineering.2.txt

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:

Page 3Support - P-10-0247 engineering.2.txt

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)

Page 4Support - P-10-0247 engineering.2.txt

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:

Page 5Support - P-10-0247 engineering.2.txt

Output 2:

to:

from:

basis:

Output 2:

to:

from:

basis:

Output 1:

Output 2:

to:

from:

basis:

Conservative:

to:

from:

basis:

Page 6Support - P-10-0247 engineering.2.txt

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

Page 7Support - P-10-0247 engineering.2.txt

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

Page 8Support - P-10-0247 engineering.2.txt

Page 9

# A-003

Initial Review Exposure Report

for PMN P-10-2479/24/10 page of



### POST FOCUS EXPOSURE REPORT

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

Results Table: Dose, Concentration, and Days Exceeded Results Summary

Exposure Scenario 1 Water Landfill Stack Air Fugitive Air

Drinking Water Fish Ingestion

ADR LADD ADR LADD 7Q10 4

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 Manufact uring (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.9/24/10 page of



### Results Table: Exposure Based (X B)/Persistent (P2B2) Criteria

Parameter Exp Based Persistent Exceedance Value

Drinking (Surface) Wate r 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)9/24/10 page of

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:9/24/10 page of

POST FOCUS EXPOSURE REPORT9/24/10 page of

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:9/24/10 page of

POST FOCUS EXPOSURE REPORT9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of

POST FOCUS EXPOSURE REPORT

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:9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-0247 Assessor: Delpire/SS9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-0247

SIC Code Comments:9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-0247 Assessor: Delpire/SS9/24/10 page of

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Chemical ID: P-10-02479/24/10 page of

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Chemical ID: P-10-02479/24/10 page of

POST FOCUS EXPOSURE REPORT

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:9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of9/24/10 page of

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:9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of9/24/10 page of

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:9/24/10 page of

POST FOCUS EXPOSURE REPORT9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of

POST FOCUS EXPOSURE REPORT

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:9/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-10-02479/24/10 page of