Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-08-510 

EPA Docket EPA-HQ-OPPT-2011-0577 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-08-510 

A-002 Initial Review Engineering Report for 

PMN P-08-510 

A-003 Initial Review Exposure Report for 

PMN P-08-510 

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A-001 

Structure Activity Team (SAT) Report

for PMN P-08-510 

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A-002 

Initial Review Engineering Report

for PMN P-08-510 

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P08-0510 ETD IRER.PF2.txt

INITIAL REVIEW ENGINEERING REPORT 

PMN: 08-0510

Post-Focus Revision 2 (10/02/2008)

ENGINEER: Eric M. Jackson

PV (kg/yr): 

SUBMITTER: 

USE: 

 

OTHER USES: No other uses were found.

MSDS: Yes Label: No

Gen Eqpt:

Respirator: 

Health Effects:

TLV/PEL:

CRSS (07/14/2008):

Chemical Name:

S-H20: 

VP: 

MW: 

Physical State and Misc CRSS Info:

Neat: Mfg: Proc/Form: 

 End Use: 

 Submitted Data: 

Estimated Data: 

UV/Vis, IR, 1H-NMR and 13C-NMR spectra are included in

the PMN submission.

Consumer Use: No

SAT (concerns) (07/15/2008):

Migration to groundwater: Negligible

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P08-0510 ETD IRER.PF2.txt

PBT rating: P1B1T1

Health: 1-2 Dermal, Inhalation

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

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS:

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

 

 

 

 

 

 

 

 

 

 

|

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim:

EXPOSURE-BASED REVIEW: 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 08-0510

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P08-0510 ETD IRER.PF2.txt

Manufacturing

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 

to: 

from: 

basis:

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)

Dermal:

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 08-0510

Processing: 

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P08-0510 ETD IRER.PF2.txt

Number of Sites/ Location: 

Days/yr: 

Basis: Submission:

.

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: 

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 

Basis:

Inhalation:

negligible (VP < 0.001 torr)

Exposure to 

Upper Bound:

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): 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 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis:

Exposure to 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis:

INITIAL REVIEW ENGINEERING REPORT 

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P08-0510 ETD IRER.PF2.txt

PMN: 08-0510

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: 

Water

Output 2: 

to:

from:

basis: 

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

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)

Exposure to 

Upper Bound:

Number of workers (all sites) with inhalation exposure: 

Basis:

INHALATION MONITORING DATA REVIEW

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P08-0510 ETD IRER.PF2.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)

Exposure to 

Upper Bound: 

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): 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 

High End: 

Number of workers (all sites) with dermal exposure: 

Basis:

Exposure to 

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: Eric M. Jackson

Organization: EPA

CALL TO: 

Organization: 

Date: 10/02/2008

Time: 2:07 PM

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P08-0510 ETD IRER.PF2.txt

Phone: 

PMN: 08-0510

 

 

CALL BY: Lisa Faeth

Organization: EPA

CALL TO: 

Organization: 

Date: 08/28/2008

Time: 1:55 PM

Phone: 

PMN: 08-0510

 

 

 

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P08-0510 ETD IRER.PF2.txt

 

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A-003 

Initial Review Exposure Report 

for PMN P-08-510 

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POST-FOCUS REVIEW EXPOSURE REPORT 

 Chemical ID: P080510.exp1 Reviewer: Cinalli 

This report was prepared using new data from P080510.en2.txt. Water release in this report have 

been decreased or eliminated and are summarized below. If you have any questions please give me a 

call at 564-8542. 

 

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

Exposure 

Scenario1 Water Landfill Stack Air Fugitive Air 

Release 

activity(ies)2; 

exposure 

calculation(s)3

Drinking Water Fish Ingestion 7Q10 

CC=? 

PDM 

Days 

Exceeded

LADD ADR LADD ADR LADD ADR LADD ADR LADD 

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 

Use: max ADR, 

PDM 

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. 

Remarks: 

Fate test recommendations?: (default is NA) 

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POST-FOCUS EXPOSURE REPORT (IRExR) 

Summary Table: Endpoints assessed 

Endpoints-Assessed Table 

Endpoints/Assessment 

Cycles1

Releases 

Assessed 

in 

NCEM2? 

Reasons for not assessing releases 

No XB 

Testing 

Required 

No 

Hazard 

Concern 

No 

Releases 

Release 

Below 

Acute 

Threshold5

Release 

Below 

Chronic 

Threshold5

Other 

Ingestion 

 Surface water 

 Ground water (landfill) 

 Consumer Use: DtD2

Inhalation 

 Air: incineration (stack)

 Air: fugitive 

 Consumer Use: CEM3

Dermal 

 Consumer Use: CEM 

Eco 

 Surface water: ADR 

conc and/or PDM4

 Consumer Use: DtD 

1

Assessment cycles are endpoint concentrations and dose calculations within the NCEM2 model. 

2

Down-the-Drain Module 

3

Consumer Exposure Module 

4

Probabilistic Dilution Model 

5

The threshold values for assessing endpoints are 1 mg/day for acute doses and 1 mg/year for chronic doses. 

Remarks: 

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 POST-FOCUS EXPOSURE REPORT 

Chemical ID: P080510 Assessor: Cinalli 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Mfg: max ADR, 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: 

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POST-FOCUS EXPOSURE REVIEW REPORT 

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POST-FOCUS REVIEW EXPOSURE REPORT 

 Chemical ID: P080510 

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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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