Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-09-316 

EPA Docket EPA-HQ-OPPT-2010-1075 

 

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Index

A-001 Structure Activity Team (SAT) Report for 

PMN P-09-316 

A-002 Initial Review Engineering Report for 

PMN P-09-316 

A-003 Initial Review Exposure Reports for 

PMN P-09-316 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-09-316 

 

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SAT Report

PMN Number: P-09-0316

SAT Date: 4/24/2009

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

 1 1 2

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal, inhalation, drinking water

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: DEVEL; IRR-E,MM; NEURO; BLOOD; ONCO; MUTA; LIVER; 

MALE REPRO; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-09-0316

FATE: 

Solid with MP = 184 EC (M)

log Kow = 1.85 (M) 

S = 1.1 g/L at 25 EC (E)

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

BP = 359 EC (E)

H < 1.00E-8 (E)

log Koc = 1.53 (E)

log Fish BCF = 0.50 (E) 

POTW removal (%) = 90 via biodeg

Time for complete ultimate aerobic biodeg = wk

Time for primary anaerobic biodeg # da 

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Sorption to soils/sediments = low

PBT Potential: P1B1

*CEB FATE: Migration to ground water = negl due to biodegradation

Direct photolysis will be rapid

Indirect photolysis will be rapid

 Health:

 Health Summary: Not absorbed through the skin as the neat material, poor

absorption through the skin if in solution, moderate absorption from the GI tract, good 

absorption from the lung (pchem); expect reduction of the in the intestines. By 

analogy to , there is concern for developmental toxicity, oncogenicity, mutagenicity, 

and neurotoxicity. There is also concern for oncogenicity, mutagenicity, liver effects and 

methemoglobinemia for the reduction product. The presence of the 

reduces the concern for oncogenicity somewhat in comparison with 

The concern for neurotoxicity is also based on . This compound is expected to be 

irritating to the eyes and mucous membranes because of the moieties. 

Also concern for male reproductive toxicity based on of the PMN 

substance; effects on the testes following an acute oral dose of 2500 mg/kg

 Test Data: rat oral LD0 = 2000 mg/kg; no skin irritation in rabbits; 

no skin sensitization in guinea pigs using the Magnusson-Kligman assay

 Ecotox:

Test 

Organism

Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 >100

daphnid 48-h LC50 >100

green algal 96-h EC50 >100

fish _ chronic value 27/0.055 30-day/60-day

daphnid chronic value 24

algal _ chronic value 280

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic Value _

Ecotox Values Comments: based on SARs for x 10; SAR chemical class = 

; MW 183; log KOW = 1.79 (EPI). 1.85 (M); hardness <180.0 mg/L as CaCO3, 

100% active ingredients, mean measured concentrations, and TOC <2.0 mg/L;

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

6

SARs

SAR Class

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A-002 

Initial Review Engineering Report 

for PMN P-09-316 

 

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INITIAL REVIEW ENGINEERING REPORT

P-09-0316

Focus Ready Draft 4/30/2009

ENGINEER: Austin \ DGR

PV (kg/yr): 

Revision Notes/Assessment Overview:

SUBMITTER: Eastman Kodak (submitter)

USE:

OTHER USES:

 

 

 

Consumer Use:

SAT (concerns): (4/27/2009):

Migration to groundwater: negl due to biodegradation

PBT rating: P1 B1 T2

Health: 2, Dermal, Drinking Water, Inhalation

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Eco: 2-3, Water (All releases to water with a CC = 6 ppb)

OCCUPATIONAL EXPOSURE RATING: 1-2A

NOTES & KEY ASSUMPTIONS:

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

 

 

POLLUTION PREVENTION CONSIDERATIONS:

P2 REC:

EXPOSURE-BASED REVIEW: No (0 criteria met)

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P-09-0316

Manufacturing: 

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

Eastman Kodak Company Rochester NY 14650

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. 

Air

: 6.3E-2 kg/site-day over 14 day/yr from 1 sites or 8.9E-1 kg/yr

Water or Incineration or Landfill

Conservative: 4.0E-2 kg/site-day over 14 day/yr from 1 sites or 5.6E-1 kg/yr

Water or Air or Incineration or Landfill

Output 2: 1.0E-2 kg/site-day over 14 day/yr from 1 sites or 1.4E-1 kg/yr

Air

Typical: 1.0E-5 kg/site-day over 14 day/yr from 1 sites or 1.4E-4 kg/yr

Worst Case: 2.0E-5 kg/site-day over 14 day/yr from 1 sites or kg/yr

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RELEASE TOTAL

1.6E+0 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 3

Basis: 

Dermal:

Exposure to Solid 

High End: 3.1E+3 mg/day over 14 days/yr

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

Basis:

Inhalation:

Exposure to Particulate 

Typical: 9.5E-2 mg/day over 14 days/yr

Worst Case: 3.2E-1 mg/day over 14 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? No

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

Inhalation Monitoring Data Desired? No

Inhalation:

Exposure to Vapor 

Typical: 4.8E-3 mg/day over 14 days/yr

Worst Case: 2.9E-1 mg/day over 14 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? No

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

Inhalation Monitoring Data Desired? No

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P-09-0316

Use: 

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

Eastman Kodak Company Rochester NY 14650

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 or Incineration or Landfill

Output 2: 8.2E-2 kg/site-day over 14 day/yr from 1 sites or 1.1E+0 kg/yr

to: Water 

from: 

Water or Air or Incineration or Landfill

Output 2: 1.0E-2 kg/site-day over 14 day/yr from 1 sites or 1.4E-1 kg/yr

to: Water, incineration, land or air

from:

Air

: 6.3E-2 kg/site-day over 14 day/yr from 1 sites or 8.9E-1 kg/yr

to: 

from:

Air

Typical: 1.0E-5 kg/site-day over 14 day/yr from 1 sites or 1.4E-4 kg/yr

Worst Case: 2.0E-5 kg/site-day over 14 day/yr from 1 sites or kg/yr

to: 

from:

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RELEASE TOTAL

2.2E+0 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 3

Basis: 

Dermal:

Exposure to Solid 

High End: 3.1E+3 mg/day over 14 days/yr

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

Basis:

Inhalation:

Exposure to Vapor 

Typical: 4.8E-3 mg/day over 14 days/yr

Worst Case: 2.9E-1 mg/day over 14 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? No

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

Inhalation Monitoring Data Desired? No

Inhalation:

Exposure to Particulate 

Typical: 9.5E-2 mg/day over 14 days/yr

Worst Case: 3.2E-1 mg/day over 14 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? No

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

Inhalation Monitoring Data Desired? No

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A-003 

Initial Review Exposure Reports 

 for PMN P-09-316 

 

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4/29/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P090316 Reviewer: Cinalli 

 

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=6 

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 7.65E-07 --- 2.23E-08 --- 1.33E-02 --- --- --- --- --- --- 

max 

LADD --- 1.19E-09 --- 1.61E-11 --- --- --- --- --- --- --- 

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 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?: 

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4/29/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090316 Assessor: 

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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4/29/2009 Page of 

INITIAL EXPOSURE REVIEW REPORT 

 Chemical ID: P090316 

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) 3.93E-03 9.16E-03 1.33E-02 1.64E-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 1.17E-09 mg/kg/day 1.59E-11 mg/kg/day 

LADCpot 6.02E-08 mg/L 1.90E-07 mg/kg 

Acute 

ADRpot 7.65E-07 mg/kg/day 2.23E-08 mg/kg/day 

Surface Water Comments: 

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4/29/2009 Page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P090316 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:2 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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4/29/2009 Page of 

INITIAL EXPOSURE REVIEW REPORT 

 Chemical ID: P090316 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER:2 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 1.19E-09 mg/kg/day 1.61E-11 mg/kg/day 

LADCpot 6.12E-08 mg/L 1.93E-07 mg/kg 

Surface Water Comments: 

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4/29/2009 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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