# Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-11-338

EPA Docket EPA-HQ-OPPT-2012-0182

# Index

A-001 Structure Activity Team (SAT) Report for

PMN P-11-338

A-002 Initial Review Engineering Report for

PMN P-11-338

A-003 Initial Review Exposure Report for

PMN P-11-338

# A-001

Structure Activity Team (SAT) Report

for PMN P-11-338

## SAT Report

PMN Number: P-11-0338

SAT Date: 5/6/2011

Print Date: 1/4/2012

Related cases : Health related cases:

Ecotox related cases :

Concern levels :



### Type of Concern: Health Eco Comments

Level of Concern: 1 3

Persistence Bioaccum Toxicity Comments

2 11

Exposure Based Review : Health: N o Ecotox: Yes

Routes of exposure : Health: N o exposures needed

Ecotox: All releases to water

Fate: ;

Keywords : Keywords:

Summary of Assessment :

Fate : Fate Summary: P-11-0338

FATE:

log Kow = 3.89 (E) S = 26.5 mg/L at 25 C (E) VP < 1.0E-6 torr at 25 C (E) BP > 400 C (E) H < 1.00E-8 (E) log Koc = 3.74 (E) log Fish BCF = 1.65 (E) log Fish BAF = 2.24 (E)

### POTW removal (%) = 25 via sorption and biodeg Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = moderate - strong

PBT Potential: P2B1 *CEB FATE: Migration to ground water = slow - moderate

Health :

the skin

.

Ecotox :

Test Organism Test Type Test End

Point Predicted Measured Comments

fish 96-h LC50 4.0 daphnid 48-h LC50 0.59
green algal 96-h EC50 0.47

fish

_ chronic value 0.080 daphnid

_ chronic

value 0.024

algal

_ chronic

value 0.11

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic

Value _

Ecotox Values Comments: Predictions are based on SARs for ; SAR

chemical class = ; MW 309; log Kow = 3.89 (EPI); S = 26.5 mg/L at 25 C (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern ( p pb) 2

SARs

SAR Class

Ecotox Category

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# A-002

Initial Review Engineering Report

for PMN P-11-338INITIAL REVIEW ENGINEERING REPORT

PMN: 11-0338
Post-Focus Draft Revision 1 10/20/2011

ENGINEER: Macek \ EV
PV (kg/yr):

**REVISION NOTES/ASSESSMENT OVERVIEW:**

The FOCUS ready draft version of the IRER dated 5/12/11 was modified to incorporate additional information provided by the submitter.

**Additional Information**

**CEB Note:**SUBMITTER:

USE:

OTHER USES:

MSDS: No Label: No

TLV/PEL: No MSDS provided.

CRSS :

Consumer Use: No

SAT (concerns) (05/06/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases:

Migration to groundwater: Slow to moderate PBT rating: P2B1T1 . Health: 1 Drinking Water Eco: 3 Water (All releases to water with a CC = 2 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2C

NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.POLLUTION PREVENTION CONSIDERATIONS:

EXPOSURE-BASED REVIEW: NoINITIAL REVIEW ENGINEERING REPORT

PMN: 11-0338

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.

**Release Source #1**

**Release Source #2**

sites

**Magnitude of Release: Media of Release:** **Release Source #3**

**Release Source #4**

**Release Source #5**

s

RELEASE TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

# A-003

Initial Review Exposure Report

for PMN P-11-33811/18/2011 Page of



### POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0338 Reviewer: Kwon/BC

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 =

2 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

USE: Max

LADD --- --- --- --- --- --- 1.74E-05 ---
--- --- ---

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 exposu re 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:11/18/2011 Page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0338 Assessor: Kwon/BC

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: 16.

Release Activity: USE: Max LADD

Release Description: WATER LANDFILL

Non-sludge/Sludge STACK FUGITIVE

Total Releases: N/A 599.04 N/A N/A

(kg/yr) (kg/yr) (kg/yr) (kg/yr)

Non-sludge/Sludge

Release Days/yr: N/A 1.00/0.00 N/A N/A

Per Site Release: N/ A 37.44/0.00 N/A N/A

(kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day)

Remarks:11/18/2011 Page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P-11-0338

DRINKING WATER EXPOSURE ESTIMATES FROM LANDFILL RELEASES

SCENARIO #: 1 ACTIVITY: USE: Max LADD

RELEASE DESCRIPTION:

EXPOSED POPULATION: Adult

NUMBER

OF

SITES NON-SLUDGE

LANDFILL

RELEASE AND

DAYS OF

RELEASE (kg/site/day)/(days) LANDFILLED

SLUDGE 1

AND DAYS OF

RELEASE
(kg/site/day)/(days) MIGRATION

DESCRIPTOR 2 ADSORPTION

TO

WASTEWATER

SLUDGE (%) DRINKING

WATER

TREATMENT (%)

16. 37.44/1.00 0.00/0.00 Moderate 0.00 0.00

1 Landfilled sludge equals the fraction adsorbed to wastewater treatment sludge times the surface water pre-treatment release.

2 Migration Descriptor Log Koc Groundwater Concentration (GWC) (mg/L per kg release) Negligible no migration None Negligible to slow > 4.5 3.21E-6

Slow <4.5 to 3.5 2.67E-5

Moderate <3.5 to 2.5 5.95E-5 Rapid <2.5 7.55E-5

ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (L/day)

Cancer

LADD pot (mg/kg/day) 1.74E-05 30.00 75.00 71.80 1.40

LADC pot (mg/L) 8.91E-04 30.00 75.00 NA NA

REMARKS: