EPA SANITIZED

Page 1 of 69 

# Support Documents for

Significant New Use Rule (SNUR) on

Premanufacture Notice (PMN)

P-11-247

EPA Docket EPA-HQ-OPPT-2012-0450

# Index

A-001 Structure Activity Team (SAT) Report for

PMN P-11-247

A-002 Initial Review Engineering Report for

PMN P-11-247

A-003 Initial Review Exposure Report for

PMN P-11-247

A-004 TSCA Section 5(e) Consent Order and

Determinations Supporting Consent Order for

PMN P-11-247

# A-001

Structure Activity Team (SAT) Report

for PMN P-11-247

### SAT Report

PMN Number: P-11-0247

SAT Date: 3/18/2011

Print Date: 5/2/2012

Related cases :

Health related cases:

Ecotox related cases :

Concern levels :



### Type of Concern: Health Eco Comments

Level of Concern: 1-2 1 Health: PMN Substance ; Eco: intact material

2 3 Health: ; Eco: incomplete incineration products

Persistence Bioaccum Toxicity Comments

3 1 1 PMN

3 2 2 Incin Pdt

Exposure Based Review :

Health:

Ecotox: N o

Routes of exposure : Health: Inhalation ; DW and Inhalaiton for incineration

p roduct

Ecotox: N o releases to water

Fate: ;

Keywords :

Keywords: PMN: LUNG OVERLOAD

LIVER; BLOOD; MALE REPRO; IMMUNOTOX; ONCO;

AQUATOX

Summary of Assessment :

Fate :

Fate Summary: P-11-0247

FATE:

Solid

S = N egl.

VP < 1.0E-6 torr at 25 C (E)

BP > 400 C (E)

H < 1.00E-8 (E)

### POTW removal (%) = 90 via sorption

Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = v.strong

PBT Potential: PMN P3B1; Incin Pdt P3B2

*CEB FATE: Migration to ground water = negl

Health :

Health Summary: Absorption is nil all routes ( p che m ). Concern for lung

toxicity if inhaled based on lung overload for high molecular weight polymers for the intact

PMN substance. For the potential incomplete incineration product, based on test data for the

concerns are liver toxicity, blood toxicity, and male reproductive toxicity

[rat 28-day oral NOAEL = 50 mg /kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral

LOAEL = 10 mg/kg based on decreased body weight in males at all doses and liver toxicity and

anemia at 200 mg/kg; there were toxic effects on the testes in 2 males in the 90-day oral study

that were judged by the reviewer to be indicative of the potential for male reproductive toxicity.

There is also concern for immunosuppression and oncogenicity based on data for

Test Data: (-) Salmonella with and without activation; (-) E. coli

with and without activation

Ecotox :

Test Organism Test

Type Test End

Point Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

fish

_ chronic value *

daphnid

_ chronic

value *

algal

_ chronic

value *

Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic

Value _

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

chemical class =

solid with mp unknown (P); S < 0.001 mg/L at 25 C (P); p H7; effective

concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0

mg/L as CaCO3; and TOC <2.0 mg/L;

high concern for the degradation product

Factors Values Comments

### Assessment Factor 10

Concentration of Concern

( p pb) *

SARs nonionic polymers

SAR Class p olyme r -nonionic

Ecotox Category

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# A-002

Initial Review Engineering Report

for PMN P-11-247

### INITIAL REVIEW ENGINEERING REPORT

PMN: 11-0247

Focus Ready Draft 3/28/2011

ENGINEER: El-Zoobi \ EV

PV (kg/yr):

SUBMITTER:

USE:

OTHER USES:

CRSS :

Consumer Use:

### SAT (concerns) (03/18/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases:

Migration to groundwater: Negligible

PBT rating: P3B2T2 PMN: P3B1T1, P3B2T2

Health: 2 Drinking Water, Inhalation

Eco: 3 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claims:

EXPOSURE-BASED REVIEW:

### INITIAL REVIEW ENGINEERING REPORT

PMN: 11-0247

Use

Number of Sites/ Location: 1

unknown site(s)

Days/yr: 250

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.

Water

Low End of Range: 6.0E-3 kg/site-day over 250 days/yr from

1 site

High End of Range: 2.0E-1 kg/site-day over 250 days/yr

from 1 site

Water or Incineration or Landfill

High End: 1.2E+0 kg/site-day over 48 days/yr from 1 site

or 6.0E+1 kg/yr

Water or Incineration or Landfill

Conservative: 8.0E-2 kg/site-day over 250 days/yr from 1

site

### or 2.0E+1 kg/yr

RELEASE TOTAL

1.3E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 6

Basis:

Inhalation:

Negligible (VP < 0.001 torr).

Dermal:

Exposure to Liquid at 20.00% concentration

Low End of Range: 1.2E+2 mg/day over 250 days/yr

High End of Range: 3.5E+2 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 6

MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: EV

Organization: ERG for EPA

### CALL TO:

Organization:

Date: 03/21/2011

Time: 1:20 PM

Phone:

PMN: 11-0247

# A-003

Initial Review Exposure Report

for PMN P-11-2473/25/11 page of



### INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P-11-0247 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 =

1000 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 ADR:

max acute eco 8.84E-04 --- --- --- 1.81E+01 --- --- 1.58E-03 ---

--- ---

USE: PDM1

--- --- --- --- 1.81E+01 --- ---

--- --- ---

USE: PDM2

--- --- --- --- 3.42E+00 --- ---

--- --- ---

USE: Max LADD --- 5.10E-06 --- ---

--- --- --- --- 2.10E-05

--- ---

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation.

2 Release activities are from engineering report's Manuf acturing (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 (A DR), Lifetime Average Daily Dose (LADD), and

Probabilistic Dilution Model (PDM). Th ere 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 7Q 10 streamflow, which is defined as the average daily

streamflow of the seven consecutive days of lowest flow within a ten year period.

Remarks:3/25/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0247 Assessor: Delpire/SS

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites:

Release Activity: USE: 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:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY:USE: Max

ADR

SIC-CODE DESCRIPTION:

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT

REMOVAL

(%) RELEASE

DAYS PRETREATMENT

RELEASE

(kg/site/day) POSTTREATMENT

RELEASE

(kg/site/day) DWT

(%) BCF

(L/kg)

0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT

TYPE % ILE

FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic

Mean 30Q5 7Q10 1Q10

ALL 50 0.84 1.97 3.17 3.84

ALL 10 2.77 10.58 18.09 21.64

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish

Ingestion

Units

50% 10% 50% 10%

Cancer

LADD pot 8.60E-07 2.84E-06 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 4.41E-05 1.46E-04 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 1.64E-04 8.84E-04 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 1 RELEASE ACTIVITY:USE: Max ADR

RELEASE DESCRIPTION:

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites:

Per Site Fugitive Release: kg/site/day

Fugitive Release Days per Year: days

% Removal via Fugitive Release: %

Total Fugitive Release: kg/yr

Max Annual Average Air Concentration

(Fugitive): 0.00 μg/m 3

Max 24 Hour Average Air

Concentration(Fugitive): 0.00 μg/m 3

Per Site Stack Release: kg/site/day

Stack Release Days per Year: days

% Removal via Stack Release: %

Total Stack Release: kg/yr

Max Annual Average Air Con centration (Stack): 0.23 μg/m 3

Max 24 Hour Average Air Concentration (Stack): 8.62 μg/m 3

ASSUMPTIONS

Exposure Units Results

(Stack) Results

(Fugitive) ED

(years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 1.67E-05 N/A 30.00 75.00 71.80 0.55

LADC pot (mg/m 3 ) 9.08E-05 N/A 30.00 75.00 NA NA

Acute

ADR pot

(mg/kg/day) 1.58E-03 N/A NA 1 day 71.80 0.55

Inhalation Comments:3/25/11 page of

Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: N/A

Inside Stack

Diameter: 0.10 m Length of Release

Opening: N/A

Stack Gas Exit

Velocity: 0.10 m/sec Width of Release

Opening: N/A

Stack Gas

Temperature: 293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m3/25/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0247 Assessor: Delpire/SS

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites:

Release Activity: USE: 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:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 Number of S ites: RELEASE ACTIVITY:USE:

PDM1

SIC-CODE DESCRIPTION:

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT

REMOVAL

(%) RELEASE

DAYS PRETREATMENT

RELEASE

(kg/site/day) POSTTREATMENT

RELEASE

(kg/site/day) DWT

(%) BCF

(L/kg)

0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT

TYPE % ILE

FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic

Mean 30Q5 7Q10 1Q10

ALL 50 0.84 1.97 3.17 3.84

ALL 10 2.77 10.58 18.09 21.64

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish

Ingestion

Units

50% 10% 50% 10%

Cancer

LADD pot 8.60E-07 2.84E-06 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 4.41E-05 1.46E-04 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 1.64E-04 8.84E-04 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY: USE: PDM1

SIC CODE DESCRIPT ION:

ASSOCIATED SIC CODES:

SIC CODE RESULTS

COC ( μ g/L) Percent of

Year COC

Exceeded Number of

Days COC

Exceeded Release

days/year Loading

(kg/site/day) Waste Water

Treatment (%) High/Avg

Analysis

1000.00 High3/25/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0247 Assessor: Delpire/SS

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites:

Release Activity: USE: PDM2

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:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3 Number of S ites: RELEASE ACTIVITY:USE:

PDM2

SIC-CODE DESCRIPTION:

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT

REMOVAL

(%) RELEASE

DAYS PRETREATMENT

RELEASE

(kg/site/day) POSTTREATMENT

RELEASE

(kg/site/day) DWT

(%) BCF

(L/kg)

0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT

TYPE % ILE

FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic

Mean 30Q5 7Q10 1Q10

ALL 50 0.16 0.37 0.60 0.73

ALL 10 0.52 2.00 3.42 4.09

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish

Ingestion

Units

50% 10% 50% 10%

Cancer

LADD pot 8.47E-07 2.80E-06 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 4.35E-05 1.44E-04 mg/L 0.00 0.00 mg/kg

Acute

ADR pot 3.11E-05 1.67E-04 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3 RELEASE ACTIVITY: USE: PDM2

SIC CODE DESCRIPT ION:

ASSOCIATED SIC CODES:

SIC CODE RESULTS

COC ( μ g/L) Percent of

Year COC

Exceeded Number of

Days COC

Exceeded Release

days/year Loading

(kg/site/day) Waste Water

Treatment (%) High/Avg

Analysis

1000.00 High3/25/11 page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P-11-0247 Assessor: Delpire/SS

ENVIRONMENTAL RELEASES

Scenario#:4 Number of Release Sites:

Release Activity: USE: 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:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 4 Number of Site s: RELEASE ACTIVITY:USE: Max

LADD

SIC-CODE DESCRIPTION:

SIC-CODE (S): EXPOSED POPULATION: Adult

WWT

REMOVAL

(%) RELEASE

DAYS PRETREATMENT

RELEASE

(kg/site/day) POSTTREATMENT

RELEASE

(kg/site/day) DWT

(%) BCF

(L/kg)

0.00 0.00

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER

PLANT

TYPE % ILE

FACILITY STREAM FLOW (MLD) STREAM CONC. ( μ g/l)

Harmonic

Mean 30Q5 7Q10 1Q10 Harmonic

Mean 30Q5 7Q10 1Q10

ALL 50 N/A N/A N/A N/A

ALL 10 N/A N/A N/A N/A

DRINKING WATER AND FISH IN GESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking

Water Units Fish Ingestion Results Fish

Ingestion

Units

50% 10% 50% 10%

Cancer

LADD pot 1.54E-06 5.10E-06 mg/kg/day 0.00 0.00 mg/kg/day

LADC pot 7.92E-05 2.62E-04 mg/L 0.00 0.00 mg/kg

Acute

ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments:3/25/11 page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P-11-0247

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 4 RELEASE ACTIVITY:USE: Max LADD

RELEASE DESCRIPTION:

METHOD OF CALCULATION: Screen3

EXPOSED POPULATION: Adult

Number of Sites:

Per Site Fugitive Release: kg/site/day

Fugitive Release Days per Year: days

% Removal via Fugitive Release: %

Total Fugitive Release: kg/yr

Max Annual Average Air Concentration

(Fugitive): 0.00 μg/m 3

Max 24 Hour Average Air

Concentration(Fugitive): N/A μg/m 3

Per Site Stack Release: kg/site/day

Stack Release Days per Year: days

% Removal via Stack Release: %

Total Stack Release: kg/yr

Max Annual Average Air Con centration (Stack): 0.29 μg/m 3

Max 24 Hour Average Air Concentration (Stack): N/A μg/m 3

ASSUMPTIONS

Exposure Units Results

(Stack) Results

(Fugitive) ED

(years) AT

(years) BW

(kg) Inh. Rate

(m 3 /hr)

Cancer

LADD pot (mg/kg/day) 2.10E-05 N/A 30.00 75.00 71.80 0.55

LADC pot (mg/m 3 ) 1.14E-04 N/A 30.00 75.00 NA NA

Acute

ADR pot

(mg/kg/day) N/A N/A NA 1 day 71.80 0.55

Inhalation Comments:3/25/11 page of

Stack Parameter Data Fugitive Parameter Data

Stack Height 10.00 m Release Height: N/A

Inside Stack

Diameter: 0.10 m Length of Release

Opening: N/A

Stack Gas Exit

Velocity: 0.10 m/sec Width of Release

Opening: N/A

Stack Gas

Temperature: 293.00 K

Meteorological and Terrain Information:

Surrounding Land Use: Rural

Terrain Height: 0.00 m

Distance to Residence of Interest: 100.00 m

Meteorological Class: Full

Stability Class: NA

Wind Speed: NA

Downwash Information:

Facility Length: NA m

Facility Width: NA m

Facility Height: NA m

# A-004

TSCA Section 5(e) Consent Order

and Determinations Supporting Consent Order

for PMN P-11-247