# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN) P-09-259

EPA Docket EPA-HQ-OPPT-2010-1075

# Index A-001 Structure Activity Team (SAT) Report for PMN P-09-259 A-002 Init ial Review Engineering Report for PMN P-09-259 A-003 I nitial Review Exposure Report for PMN P-09-259

# A-001 Structure Activity Team (SAT) Report for PMN P-09-259

## SAT Report PMN Number: P-09-0259 SAT Date: 3/20/2009

Related cases : Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 2 3 Health: ; Eco: chronic concern only

Persistence Bioaccum Toxicity Comments 3 3 2 Exposure Based Review : Health: Ecotox: N o Routes of exposure : Health: Dermal, inhalation, drinking water Ecotox: All releases to water Fate: ; Keywords : Keywords: ONCO; MUTA; IMMUNOTOX; DEVEL (UNCERT); LIVER (UNCERT); SENS (UNCERT); IRR-E,S (UNCERT); AQUATOX Summary of Assessment :
Fate : Fate Summary: P-09-0259 FATE: Solid with MP = 187 EC (E) log Kow = 7.30 (E); S < 0.001 mg/L at 25 EC (E) VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E) H = 3.08E-7 (E) log Koc = 5.68 (E) log Fish BCF = 4.56 (E) POTW removal (%) = 90 via sorption Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = v.strong

### PBT Potential: P3B3 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is nil all routes as the neat material, p oor all routes if in solution ( p che m ). Concern for oncogenicity, mutagenicity, immunotoxicity, liver (uncertain), and sensitization (uncertain) based in Uncertain concern for developmental toxicity based on and irritation to eyes and skin. Test Data: (-) Salmonella strains TA98 and TA100 with and without activation, Inconclusive
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 0.001 daphnid

_ chronic value 0.002 algal

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

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for neutral organic chemicals; SAR chemical class = MW 386; log Kow = 7.30 (EPI); liquid with unknown mp; S = 0.0011 mg/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) 1

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

# A-002 Initial Review Engineering Report for PMN P-09-259

### TEST DATA REVIEW ENGINEERING REPORT P-09-0259 Post-Focus Draft 6/4/2009

ENGINEER: El-Zoobi \ JAS PV (kg/yr):

SUBMITTER:

USE:

SAT (concerns): (3/20 /2009): Migration to groundwater: N egligible PBT rating: P 3 B 3 T 2 Health: 2, Dermal, Drinking Water, 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 REC:

EXPOSURE -BASED REVIEW: N o (0 criteria met)P-09-0259

USE:

Number of Sites/Location: 1 submitter site(s)
Basis: Process Description:



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

Air Output 2: 5.0E-3 kg/site-day over 25 day/yr from 1 sites or 1.2E-1 kg/y r to: uncertain from: basis:

Incineration Output 2: 1.0E-2 kg/site-day over 25 day/yr from 1 sites or 2.5E-1 kg/y r to: uncertain from: basis:



## RELEASE TOTAL 3.8E-1 kg/y r - all sites



## OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 3 Basis:

Inhalation:Exposure to Particulate Upper Bound: 1.5E+2 mg/day over 25 days/y r



## 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 (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o
Dermal: Exposure to Solid High End: 3.1E+3 mg/day over 25 days/y r Number of workers (all sites) with Dermal exposure: 3P-09-0259

MFG:

Number of Sites/Location: 1 submitter site(s)



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

Air Output 2: 1.9E-2 kg/site-day over 7 day/yr from 1 sites or 1.3E-1 kg /y r to: uncertain from: basis:



## RELEASE TOTAL 1.3E-1 kg/y r - all sites



## OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 12 Basis:

Dermal: Exposure to Solid High End: 3.1E+3 mg/day over 25 days/y r Number of workers (all sites) with Dermal exposure: 12 Basis:

Inhalation: Exposure to Particulate Typical: 4.8E-2 mg/day over 25 days/y r Worst Case: 1.6E-1 mg/day over 25 days/y r Number of workers (all sites) with Inhalation exposure: 12Basis:



## 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? N o (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o
Dermal: Exposure to Liquid High End: 8.8E+2 mg/day over 25 days/y r Number of workers (all sites) with Dermal exposure: 12 Basis:

### TEST DATA REVIEW ENGINEERING REPORT P-09-0259 Post-Focus Draft 6/4/2009

ENGINEER: El-Zoobi \ JAS PV (kg/yr):

SUBMITTER:

Consumer Use: SAT (concerns): (3/20 /2009): Migration to groundwater: N egligible PBT rating: P 3 B 3 T 2 Health: 2, Dermal, Drinking Water, 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 REC:

EXPOSURE -BASED REVIEW: N o (0 criteria met)P-09-0259

USE:

Number of Sites/Location: 1 submitter site(s)
Basis: Process Description:



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

Air Output 2: 5.0E-3 kg/site-day over 25 day/yr from 1 sites or 1.2E-1 kg/y r to: uncertain from: basis:

Incineration Output 2: 1.0E-2 kg/site-day over 25 day/yr from 1 sites or 2.5E-1 kg/y r to: uncertain from: basis:



## RELEASE TOTAL 3.8E-1 kg/y r - all sites



## OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 3 Basis:

Inhalation:Exposure to Particulate Upper Bound: 1.5E+2 mg/day over 25 days/y r Number of workers (all sites) with Inhalation exposure: 3 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 (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o
Dermal: Exposure to Solid High End: 3.1E+3 mg/day over 25 days/y r Number of workers (all sites) with Dermal exposure: 3 Basis:P-09-0259

MFG:

Number of Sites/Location: 1 submitter site(s)
Basis: Process Description:



## ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

Air Output 2: 1.9E-2 kg/site-day over 7 day/yr from 1 sites or 1.3E-1 kg /y r to: uncertain from: basis:



## RELEASE TOTAL 1.3E-1 kg/y r - all sites



## OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: 12 Basis:

Dermal: Exposure to Solid High End: 3.1E+3 mg/day over 25 days/y r Number of workers (all sites) with Dermal exposure: 12 Basis:

Inhalation: Exposure to Particulate Typical: 4.8E-2 mg/day over 25 days/y r Worst Case: 1.6E-1 mg/day over 25 days/y r Number of workers (all sites) with Inhalation exposure: 12Basis:



## 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? N o (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o
Dermal: Exposure to Liquid High End: 8.8E+2 mg/day over 25 days/y r Number of workers (all sites) with Dermal exposure: 12 Basis:

# A-003 Initial Review Exposure Report for PMN P-09-2593/15/09 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)

Chemical ID: P090259 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=1 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 ADR, max acute eco. 1.05E-06 --- 3.78E-04 --- 1.94E-02 --- --- --- --- --- --- PDM --- --- --- --- 8.56E-03 0 --- --- --- --- ---
max LADD --- 1.84E-09 --- 2.88E-07 --- --- --- --- --- --- --- 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 concernn. 4 This column displays concentratio 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)3/15/09 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090259 Assessor: Flessner
ENVIRONMENTAL RELEASES
Scenario#:1 Number of Release Sites: Release Activity: max ADR, max acute eco. 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:3/15/09 Page of

INITIAL EXPOSURE REVIEW REPORT
Chemical ID: P090259 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER:1 RELEASE ACTIVITY : max ADR, max acute eco.
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) 5.76E-03 1.26E-02 1.94E-02 2.37E-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 8.61E-10 mg/kg/day 1.35E-07 mg/kg/day
LADC pot 4.42E-08 mg/L 1.61E-03 mg/kg
Acute
ADR pot 1.05E-06 mg/kg/day 3.78E-04 mg/kg/day

Surface Water Comments:3/15/09 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090259 Assessor:
ENVIRONMENTAL RELEASES
Scenario#:2 Number of Release Sites: Release Activity: 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:3/15/09 Page of

INITIAL EXPOSURE REVIEW REPORT
Chemical ID: P090259 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER:2 RELEASE ACTIVITY: PDM
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) 2.54E-03 5.55E-03 8.56E-03 1.05E-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 1.36E-09 mg/kg/day 2.12E-07 mg/kg/day
LADC pot 6.96E-08 mg/L 2.54E-03 mg/kg
Acute
ADR pot 4.64E-07 mg/kg/day 1.67E-04 mg/kg/day

Surface Water Comments:3/15/09 Page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P090259

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER: 2 RELEASE ACTIVITY: PDM
FACILITY NAME:
FACILITY LOCATION:
RECEIVING STREAM NAME:
REACH NUMBER FACILITY ON REACH: DISCHARGE TYPE
NPDES PERMIT NUMBER: GAGING STATION ID: GAGING STATION PERIOD OF RECORD GAGING STATION NUMBER OF OBSERVATIONS: NUMBER OF STATIONS ON REACH:

50 %ile FLOW (MLD): 10 %ile FLOW (MLD): EFFLUENT FLOW (MLD)

RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Pre-treatment Loading (kg/site/day) Waste Water Treatment (%)

1.00 0 03/15/09 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090259 Assessor:
ENVIRONMENTAL RELEASES
Scenario#:3 Number of Release Sites: Release Activity: 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:3/15/09 Page of

INITIAL EXPOSURE REVIEW REPORT
Chemical ID: P090259 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES
SCENARIO NUMBER:3 RELEASE ACTIVITY max 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)

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 1.84E-09 mg/kg/day 2.88E-07 mg/kg/day
LADC pot 9.43E-08 mg/L 3.44E-03 mg/kg
Acute
ADR pot

Surface Water Comments:3/15/09 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.