# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-09-316

EPA Docket EPA-HQ-OPPT-2010-1075

# 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

# A-001 Structure Activity Team (SAT) Report
for PMN P-09-316

## 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: N o
Routes of exposure : Health: Dermal, inhalation, drinking water Ecotox: All releases to water Fate: ; Keywords : Keywords: DEVEL; IRR-E,MM; N EURO; 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

### 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: N ot absorbed through the skin as the neat material, p oo r absorption through the skin if in solution, moderate absorption from the GI tract, good absorption from the lung ( p che m ); 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 ( p pb) 6

SARs SAR Class

# A-002 Initial Review Engineering Report
for PMN P-09-316

### 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: P 1 B 1 T 2 Health: 2, Dermal , Drinking Water , InhalationEco: 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: N o (0 criteria met)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/y r

Water or Incineration or Landfill Conservative: 4.0E-2 kg/site -day over 14 day/yr from 1 sites or 5.6E-1 kg/y r

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/y r

Air Typical: 1.0E-5 kg/site-day over 14 day/yr from 1 sites or 1.4E-4 kg /y r Worst Case: 2.0E-5 kg/site-day over 14 day/yr from 1 sites or kg/y r

## RELEASE TOTAL 1.6E+0 kg/y r - 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/y r Number of workers (all sites) with Dermal exposure: 3 Basis:

Inhalation:
Exposure to Particulate Typical: 9.5E-2 mg/day over 14 days/y r Worst Case: 3.2E-1 mg/day over 14 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? N o (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o

Inhalation:
Exposure to Vapor Typical: 4.8E-3 mg/day over 14 days/y r Worst Case: 2.9E-1 mg/day over 14 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? N o (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N oP-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/y r 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/y r 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/y r to: from:

Air Typical: 1.0E-5 kg/site-day over 14 day/yr from 1 sites or 1.4E-4 kg /y r Worst Case: 2.0E-5 kg/site-day over 14 day/yr from 1 sites or kg/y r to: from:

## RELEASE TOTAL 2.2E+0 kg/y r - 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/y r Number of workers (all sites) with Dermal exposure: 3 Basis:

Inhalation:
Exposure to Vapor Typical: 4.8E-3 mg/day over 14 days/y r Worst Case: 2.9E-1 mg/day over 14 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? N o (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o

Inhalation:
Exposure to Particulate Typical: 9.5E-2 mg/day over 14 days/y r Worst Case: 3.2E-1 mg/day over 14 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? N o (b) Hazard Rating for health of 2 or greater? N o Inhalation Monitoring Data Desired? N o

# A-003 Initial Review Exposure Reports
for PMN P-09-3164/29/2009 Page of

INITIAL REVIEW EXPO SURE REPORT (IRExR)

Chemical ID: P090316 Reviewer: Cinalli
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=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 μ g/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-0 9 --- 1.61E-11 --- --- --- --- --- --- ---
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?: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: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 ( μ g/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

LADD pot 1.17E-09 mg/kg/day 1.59E-11 mg/kg/day

LADC pot 6.02E-08 mg/L 1.90E-07 mg/kg

Acute

ADR pot 7.65E-07 mg/kg/day 2.23E-08 mg/kg/day

Surface Water Comments: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: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 AC TIVITY: 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 1.19E-09 mg/kg/day 1.61E-11 mg/kg/day

LADC pot 6.12E-08 mg/L 1.93E-07 mg/kg

Surface Water Comments:4/29/2009 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.