# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-09-356

EPA Docket EPA-HQ-OPPT-2010-1075

# Index
A-001 Structure Activity Team (SAT) Report for PMN P-09-356
A-002 Initial Review Engineering Report for PMN P-09-356
A-003 I nitial Review Exposure Report for PMN P-09-356

# A-001 Structure Activity Team (SAT) Report
for PMN P-09-356

## SAT Report PMN Number: P-09-0356 SAT Date: 5/22/2009

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 3 1 1 Exposure Based Review : Health: Ecotox: N o Routes of exposure : Health: Inhalation Ecotox: All releases to water Fate: ;

P 2 Rec Comments : Comment: SAT had no comment
Keywords : Keywords: SENS; IRR-E,L,MM (UNCERT); AQUATOX Summary of Assessment :
Fate : Fate Summary: P-09-0356 FATE: Estimations for neutralized log Kow = -3.05 (M) log Koc = 1.00 (E) log Fish BCF = 0.50 (E) PMN Substance: Solid S > 10 g/L at 25 EC (ICB) VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E)

### H < 1.00E-8 (E) POTW removal (%) = 50 via biodeg Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = low PBT Potential: PMN and : P1B1; P3B1 *CEB FATE: Migration to ground water = slow - moderate

Health : Health Summary: N ot absorbed from the skin, absorbed from the lung ( p che m ), absorbed from the GI tract (analog). Concern for sensitization based on and uncertain concern for irritation to eyes, mucous membranes and lungs based on the groups.
Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 34 daphnid 48-h LC50 43 green algal 96-h EC50 5.9 fish

_ chronic value 1.2 daphnid chronic value 1.6 algal

_ chronic value 3.8 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for compounds with ; SAR chemical class = ; MW 413; solid with unknown mp (P); S > 100 g/L at 20 °C (P); 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;
Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 120

SARs SAR Class
Ecotox Factors Comments:
SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report
for PMN P-09-356

### INITIAL REVIEW ENGINEERING REPORT P-09-0356 Focus Ready Draft 6/1/2009

ENGINEER: Jon \ AH PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

Consumer Use : SAT (concerns): (5/22/2009): Migration to groundwater: Slow to moderate PBT rating: P 3 B 1 T 1 PMN: P1B1T1; P3B1T1 Health: 1-2, Inhalation Eco: 2, Water (All releases to water with a CC = 120 ppb)

OCCUPATIONAL EXPOSURE RATING : 2C

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

P2 REC:

EXPOSURE-BASED REVIEW:P-09-0356

Processing:

Number of Sites/Location:

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 TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:P-09-0356

Manufacturing

Number of Sites/Location:

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.



## OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:P-09-0356

Number of Sites/Location:

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 TOTAL

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:

# A-003 Initial Review Exposure Report
for PMN P-09-3565/29/2009 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)
Chemical ID: P090356 Reviewer: Delpire
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=120 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, PDMa --- --- --- --- 142.66 1 --- --- --- --- --- PDMb --- --- --- --- 32.92 0 --- --- --- --- --- max Acute Eco, max ADR --- --- --- --- 3584.91 --- --- --- --- 8.09E-02 --- 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?:5/29/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090356 Assessor: Delpire
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: max Acute Eco, PDMa 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:5/29/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090356

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

SCENARIO #: 1 Number of Sites RELEASE ACTIVITY max Acute Eco, PDMa
SIC-CODE DESCRIPTION: SIC-CODE (S) EX POSED 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 4.80 17.24 28.01 33.87
ALL 10 29.35 83.13 142.66 170.49

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 2.26E-06 1.38E-05 mg/kg/day 3.06E-08 1.87E-07 mg/kg/day
LADC pot 1.16E-04 7.08E-04 mg/L 3.66E-04 2.24E-03 mg/kg
Acute
ADR pot 1.44E-03 6.95E-03 mg/kg/day 2.73E-05 1.67E-04 mg/kg/day

SIC Code Comments:5/29/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090356

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 RELEASE ACTIVITY max Acute Eco, PDMa
SIC CODE DES CRIPTION:
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

120.00 0 1 High5/29/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090356 Assessor:
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: PDMb 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:5/29/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090356

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

SCENARIO #: 2 Number of Site s: RELEASE ACTIVITY PDMb
SIC-CODE DESCRIPTION: SIC-CODE (S): EX POSED 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 1.11 3.98 6.46 7.82
ALL 10 6.77 19.18 32.92 39.34

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 1.18E-06 7.24E-06 mg/kg/day 1.60E-08 9.80E-08 mg/kg/day
LADC pot 6.08E-05 3.71E-04 mg/L 1.92E-04 1.17E-03 mg/kg
Acute
ADR pot 3.33E-04 1.60E-03 mg/kg/day 6.29E-06 3.84E-05 mg/kg/day

SIC Code Comments:5/29/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090356

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY: PDMb
SIC CODE DES CRIPTION:
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

120.00 0 0 High5/29/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090356 Assessor:
ENVIRONMENTAL RELEASES
Scenario#:3 Number of Release Sites: Release Activity: max Acute Eco, 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:5/29/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090356

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

SCENARIO #: 3 Number of Site s: RELEASE ACTIVITY : max Acute Eco, max ADR
SIC-CODE DESCRIPTION: SIC-CODE (S): EX POSED 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 50 125.56 44.02 26.80 22.53 30.26 86.32 141.79 168.66
ALL 10 11.11 1.94 1.06 0.96 342.03 1958.76 3584.91 3958.33

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 3.88E-06 4.39E-05 mg/kg/day 5.25E-08 5.94E-07 mg/kg/day
LADC pot 1.99E-04 2.25E-03 mg/L 6.29E-04 7.11E-03 mg/kg
Acute
ADR pot 7.21E-03 0.16 mg/kg/day 1.72E-04 1.94E-03 mg/kg/day

SIC Code Comments:5/29/2009 Page of

INITIAL EXPOSURE REVIEW REPORT Chemical ID: P090356

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 3 RELEASE ACTIVITY max Acute Eco, 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: 0.00 % Total Fugitive Release: kg/yr Max Annual Average Air Concentration (Fugitive): 0.57 μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): 440.00 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 4.23E-05 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) N/A 2.30E-04 30.00 75.00 NA NA
Acute
ADR pot

(mg/kg/day) N/A 8.09E-02 NA 1 day 71.80 0.55

Inhalation Comments:5/29/2009 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 m5/29/2009 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.