# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-09-390

EPA Docket EPA-HQ-OPPT-2010-1075

# Index
A-001 Structure Activity Team (SAT) Report for PMN P-09-390
A-002 Initial Review Engineering Report for PMN P-09-390
A-003 Initial Review Exposure Report for PMN P-09-390

# A-001 Structure Activity Team (SAT) Report
for PMN P-09-390

## SAT Report PMN Number: P-09-0390 SAT Date: 6/12/2009

Related cases : Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 2

Persistence Bioaccum Toxicity Comments 1 1 1 Exposure Based Review : Health: Ecotox: N o Routes of exposure : Health: Dermal, inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: IRR-E,S,MM,L; SENS-L; MUTA; AQUATOX Summary of Assessment :
Fate : Fate Summary: P-09-0390 FATE: Solid with MP = 90 EC (M) log Kow = 1.11 (E); S = 5.37 g/L at 25 EC (E) VP = 1.6 torr at 25 EC ( N OMO5) BP = 169 EC ( N OMO5) based on 112 EC @ 115 mm Hg (M) H = 3.58E-8 (E) log Koc = 1.46 (E) log Fish BCF = 0.40 (E) POTW removal (%) = 90 via biodeg; OECD 301B (Mod Sturm CO2 Ev): 14%/28d NRB. Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = low

### PBT Potential: P1B1 *CEB FATE: Migration to ground water = moderate - rapid

Health : Health Summary: N ot absorbed through the skin as the neat material ( p che m ), moderate absorption through the skin if in solution (analog), absorbed from the lung and GI tract (analog). Concern for mutagenicity (+) for chromosome aberrations in CHO cells with and without activation ; irritation to all tissues severe eye and skin irritation in rabbits ; and respiratory sensitization based on

Test Data: (-) Salmonella with and without activation; rat oral LD0 = 2000 mg/kg; no skin irritation in rabbits; no eye irritation in rabbits; (-) for skin sensitization in a mouse local lymph node assay up to 25% ai

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 29 daphnid 48-h LC50 22 >100 green algal 96-h EC50 0.49 fish

_ chronic value 0.49 daphnid

_ chronic value 0.45 algal

_ chronic value 0.21 Sewage Sludge 3-h EC50 Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = ; MW 127; log Kow = 1.11 (EPI); solid with mp = 90 C (M); S = 5.37 g/L in water at 20 °C (M); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0 mg/L;
An acute daphnid test was submitted with this PMN. Evaluation details are provided on the accompanying spreadsheet (attached).
Conclusion: The results from the Daphnid test is considered valid . Test concentrations were within 95 - 96 % of nominal therefore nominal test concentrations are reported . One Daphnid was observed to be immobilized after 48 hours exposure but this was considered to be due to handling stress and/or natural causes and not due to the test material exposure. The CC is derived from the 48-hr EC50 value of 100 mg/L. This value is divided by an assessment (uncertainty) factor of 10 and then divided again by ten to simulate a chronic value. This yields a CC = 1 mg/L or 1,000 μg/L ( p pb). However, because only an acute daphnid test was conducted and ECOSAR predicts that algae are significantly more sensitive, The ECOSAR predicted CC of 21 p pb will be used for this material. The PMN substance P09-0390 is of moderate concern for

### ecotoxicity.

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 21

SARs SAR Class

Ecotox Factors Comments:
SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report
for PMN P-09-390

### INITIAL REVIEW ENGINEERING REPORT P-09-0390 Focus Ready Draft 6/22/2009

ENGINEER: Hall \ CPW PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

SAT (concerns): (6/12 /2009):
Migration to groundwater: Moderate to Rapid PBT rating: P 1 B 1 T 1 Health: 1-2, Dermal , Inhalation Eco: 2, Water (All releases to water with a CC = 21 ppb.)

OCCUPATIONAL EXPOSURE RATING: 2-3ANOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE -BASED REVIEW: N o (0 criteria met)P-09-0390

# A-003 Initial Review Exposure Report
for PMN P-09-3906/19/09 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)

Chemical ID: P090390 Reviewer: Sherer
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=21 PDM Days Exceeded 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 μ g/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day max acute eco.; max ADR, LADD (fugitive) --- --- --- --- 369.69 --- --- --- --- 0.50 2.21E-04

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. 4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average streamflow of the 7 consecutive days of lowest flow within a 10 year period.

Remarks:
Fate test recommendations?: (default is NA)6/19/09 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090390 Assessor: Sherer

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: max acute eco; max ADR, 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:6/19/09 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090390

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

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY max acute eco; max ADR, 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)

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 0.71 2.14 3.15 3.89
ALL 10 39.55 213.22 369.69 441.50

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 7.56E-08 4.23E-06 mg/kg/day 8.17E-10 4.56E-08 mg/kg/day
LADC pot 3.88E-06 2.17E-04 mg/L 9.77E-06 5.46E-04 mg/kg
Acute
ADR pot 1.79E-04 1.78E-02 mg/kg/day 3.20E-06 1.79E-04 mg/kg/day

SIC Code Comments:6/19/09 Page of

INITIAL EXPOSURE REVIEW REPORT Chemical ID: P090390

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 1 RELEASE ACTIVITY max acute eco; max ADR, 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: 0.00 % Total Fugitive Release: kg/yr Max Annual Average Air Concentration (Fugitive): 3.00 μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): 2730.00 μg/m 3

Per Site Stack Release: NA kg/site/day Stack Release Days per Year: NA days
% Removal via Stack Release: %
Total Stack Release: NA kg/yr Max Annual Average Air Con centration (Stack): 0.00 μg/m 3
Max 24 Hour Average Air Concentration (Stack): 0.00 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) N/A 2.21E-04 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) N/A 1.20E-03 30.00 75.00 NA NA
Acute
ADR pot

(mg/kg/day) N/A 0.50 NA 1 day 71.80 0.556/19/09 Page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 Release Height: 3.00 m
Inside Stack Diameter: 0.10 Length of Release Opening: 10.00 m

Stack Gas Exit Velocity: 0.10 Width of Release Opening: 10.00 m

Stack Gas Temperature: 293.00

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 m6/19/09 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.8/5/09 Page of



### POST FOCUS EXPOSURE REPORT

Chemical ID: P090390 Reviewer: Flessner
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=21 PDM Days Exceeded 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 μ g/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day max acute eco; max ADR, LADD (fugitive) --- --- --- --- 8.09E-03 --- --- --- --- 0.50 2.21E-04

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. 4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average streamflow of the 7 consecutive days of lowest flow within a 10 year period.

Remarks:

Fate test recommendations: (default is NA)8/5/09 Page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P090390 Assessor: Flessner

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: max acute eco; max ADR, 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:8/5/09 Page of

POST FOCUS EXPOSURE REPORT

Chemical ID: P090390 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER:1 RELEASE ACTIVITY: max acute eco; max ADR, LADD

FACILITY NAME
FACILITY LOCATION:
RECEIVING WATER NAME:
REACH NUMBER: FACILITY ON REACH: DISCHARGE TYPE:
NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg)

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER
FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT FLOW (MLD) CONCENTRATION ( μ g/L) 2.46E-03 6.72E-03 8.09E-03 1.04E-02 NA

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES

Exposure Units Drinking Water Results Drinking Water Units Fish Ingestion Results Fish Ingestion Units

Cancer

LADD pot 2.63E-10 mg/kg/day 2.84E-12 mg/kg/day

LADC pot 1.35E-08 mg/L 3.40E-08 mg/kg

Acute

ADR pot 5.62E-07 mg/kg/day 1.11E-08 mg/kg/day

Surface Water Comments:8/5/09 Page of

POST FOCUS EXPOSURE REPORT Chemical ID: P090390

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 1 RELEASE ACTIVITY : max acute eco; max ADR, 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: 0.00 % Total Fugitive Release: kg/yr Max Annual Average Air Concentration (Fugitive): 3.00 μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): 2730.00 μg/m 3

Per Site Stack Release: NA kg/site/day Stack Release Days per Year: NA days
% Removal via Stack Release: %
Total Stack Release: NA kg/yr Max Annual Average Air Con centration (Stack): 0.00 μg/m 3
Max 24 Hour Average Air Concentration (Stack): 0.00 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) N/A 2.21E-04 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) N/A 1.20E-03 30.00 75.00 NA NA
Acute
ADR pot

(mg/kg/day) N/A 0.50 NA 1 day 71.80 0.55

Inhalation Comments:8/5/09 Page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 Release Height: 3.00 m
Inside Stack Diameter: 0.10 Length of Release Opening: 10.00 m

Stack Gas Exit Velocity: 0.10 Width of Release Opening: 10.00 m

Stack Gas Temperature: 293.00

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 m8/5/09 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.