Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-259 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-259 

A-002 Initial Review Engineering Report for 

PMN P-09-259 

A-003 Initial Review Exposure Report for 

PMN P-09-259 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-09-259 

 

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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: No

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

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PBT Potential: P3B3

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes as the neat material, poor all 

routes if in solution (pchem). 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); pH7; 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 

(ppb)

1

SARs neutral organic chemicals

SAR Class

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-09-259 

 

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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: Negligible

PBT rating: P3 B3 T2

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. 

EPA SANITIZED Page 7 of 28
 

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: No (0 criteria met)

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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/yr

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/yr

to: uncertain

from: 

basis:

RELEASE TOTAL

3.8E-1 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 3

Basis:

Inhalation:

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Exposure to Particulate 

Upper Bound: 1.5E+2 mg/day over 25 days/yr

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? No

Inhalation Monitoring Data Desired? No

Dermal:

Exposure to Solid 

High End: 3.1E+3 mg/day over 25 days/yr

Number of workers (all sites) with Dermal exposure: 3

EPA SANITIZED Page 10 of 28
P-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/yr

to: uncertain

from: 

basis: 

RELEASE TOTAL

1.3E-1 kg/yr - 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/yr

Number of workers (all sites) with Dermal exposure: 12

Basis: 

Inhalation:

Exposure to Particulate 

Typical: 4.8E-2 mg/day over 25 days/yr

Worst Case: 1.6E-1 mg/day over 25 days/yr

Number of workers (all sites) with Inhalation exposure: 12

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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? No

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

Dermal:

Exposure to Liquid 

High End: 8.8E+2 mg/day over 25 days/yr

Number of workers (all sites) with Dermal exposure: 12

Basis: 

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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: Negligible

PBT rating: P3 B3 T2

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. 

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POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: No (0 criteria met)

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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/yr

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/yr

to: uncertain

from: 

basis:

RELEASE TOTAL

3.8E-1 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 3

Basis:

Inhalation:

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Exposure to Particulate 

Upper Bound: 1.5E+2 mg/day over 25 days/yr

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? No

Inhalation Monitoring Data Desired? No

Dermal:

Exposure to Solid 

High End: 3.1E+3 mg/day over 25 days/yr

Number of workers (all sites) with Dermal exposure: 3

Basis:

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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/yr

to: uncertain

from: 

basis: 

RELEASE TOTAL

1.3E-1 kg/yr - 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/yr

Number of workers (all sites) with Dermal exposure: 12

Basis: 

Inhalation:

Exposure to Particulate 

Typical: 4.8E-2 mg/day over 25 days/yr

Worst Case: 1.6E-1 mg/day over 25 days/yr

Number of workers (all sites) with Inhalation exposure: 12

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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? No

 (b) Hazard Rating for health of 2 or greater? No

Inhalation Monitoring Data Desired? No

Dermal:

Exposure to Liquid 

High End: 8.8E+2 mg/day over 25 days/yr

Number of workers (all sites) with Dermal exposure: 12

Basis: 

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A-003 

Initial Review Exposure Report 

 for PMN P-09-259 

 

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3/15/09 Page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090259 Reviewer: Flessner 

 

Results Table: Dose, Concentration, and Days Exceeded Results Summary 

Exposure Scenario1 Water Landfill Stack Air Fugitive Air 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 

7Q104 

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 μg/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 activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manufacturing (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) 

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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: 

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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 (μg/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 

LADDpot 8.61E-10 mg/kg/day 1.35E-07 mg/kg/day 

LADCpot 4.42E-08 mg/L 1.61E-03 mg/kg 

Acute 

ADRpot 1.05E-06 mg/kg/day 3.78E-04 mg/kg/day 

Surface Water Comments: 

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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: 

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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 (μg/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 

LADDpot 1.36E-09 mg/kg/day 2.12E-07 mg/kg/day 

LADCpot 6.96E-08 mg/L 2.54E-03 mg/kg 

Acute 

ADRpot 4.64E-07 mg/kg/day 1.67E-04 mg/kg/day 

Surface Water Comments: 

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3/15/09 Page of 

INITIAL REVIEW EXPOSURE 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 (μg/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 0 

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3/15/09 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: 

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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 (μg/L) 

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water 

Results 

Drinking Water 

Units 

Fish Ingestion 

Results 

Fish Ingestion 

Units 

Cancer 

LADDpot 1.84E-09 mg/kg/day 2.88E-07 mg/kg/day 

LADCpot 9.43E-08 mg/L 3.44E-03 mg/kg 

Acute 

ADRpot 

Surface Water Comments: 

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3/15/09 Page of 

LEGEND FOR NEW CHEMICALS EXPOSURE REPORT 

This new chemicals exposure report was 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 calculate 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 abbreviations on the Release Activity line, e.g., (1) max ADR, (2) max 

LADD, (3) max PDM. Depending on the release inputs, these endpoints 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 calculated 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 processing 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 directs 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) chemicals of P2B2 rating or higher 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 that are also health or eco concerns are bolded. 

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