# Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-08-510

EPA Docket EPA

- HQ

- OPPT -2011-0577

# Index

A-001 Structure Activity Team (SAT) Report for

PMN P-08-510

A-002 Initial Rev iew Engineering Report for

PMN P-08-510

A-003 Initial Review Exposure Report for

PMN P-08-510

# A-001

Structure Activity Team (SAT) Report

for PMN P-08-510

# A-002

Initial Review Engineering Report

for PMN P-08-510P08-0510 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

Page 1P08-0510 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

Page 2P08-0510 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:

Page 3P08-0510 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

Page 4P08-0510 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

Page 5P08-0510 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

Page 6P08-0510 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

Page 7P08-0510 ETD IRER.PF2.txt

Page 8

# A-003

Initial Review Exposure Rep ort

for PMN P-08-51010/8/08 Page of

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 be low. If you have any que stions please give me a

call at 564-8542.

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

Exposure

Scenario 1 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 μ g/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 activ ity followed by exposure calculation abbreviation.

2 Release activities are from engineering report's Manufactur ing (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)10/8/08 Page of

POST-FOCUS EXPOSURE REPORT (IRExR)

Summary Table: Endpoints assessed

Endpoints-Assessed Table

Endpoints/Assessment

Cycles 1 Releases

Assessed

in

NCEM2? Reasons for not assessing releases

No XB

Testing

Required No

Hazard

Concern No

Releases Release

Below

Acute

Threshold 5 Release

Below

Chronic

Threshold 5 Other

Ingestion

Surface water

Ground water (landfill)

Consumer Use: DtD 2

Inhalation

Air: incineration (stack)

Air: fugitive

Consumer Use: CEM 3

Dermal

Consumer Use: CEM

Eco

Surface water: ADR

conc and/or PDM 4

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:10/8/08 Page of

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:10/8/08 Page of

POST-FOCUS EXPOSURE REVIEW REPORT10/8/08 Page of

POST-FOCUS REVIEW EXPOSURE REPORT

Chemical ID: P08051010/8/08 Page of



## LEGEND FOR NEW CHEMICAL S EXPOSURE REPORT

This new chemicals exposure report wa s 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 calcula te 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 abbreviati ons on the Release Activity line, e.g., (1) max ADR , (2) max

LADD , (3) max PDM . Depending on the release inputs, these e ndpoints 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 cal culated 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 proce ssing 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 dir ects 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) chemical s of P2B2 rating or hi gher 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 th at are also health or eco concerns are bolded.