# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)

P-09-532

EPA Docket EPA-HQ-OPPT-2010-1075

# Index

A-001 Structure Activity Team (SAT) Report for PMN P-09-532

A-002 Initial Review Engineering Report for PMN P-09-532

A-003 Initial Review Exposure Report for PMN P-09-532

# A-001 Structure Activity Team (SAT) Report

for PMN P-09-532

## SAT Report PMN Number: P-09-0532 SAT Date: 8/11/2009

Related cases : Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1 3

Persistence Bioaccum Toxicity Comments 2 1 1
Exposure Based Review : Health: N o Ecotox: N o
Routes of exposure : Health: Ecotox: All releases to water Fate: ; Keywords : Keywords: AQUATOX-A,C
Summary of Assessment :

Fate : Fate Summary: P-09-0532 FATE: Solid log Kow = 5.32 (E); S = 0.092 mg/L at 25 EC (E) VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E) H < 1.00E-8 (E) log Koc = 4.48 (E) log Fish BCF = 3.18 (E) log Fish BAF = 1.09 (E) POTW removal (%) = 75-90 via sorption and possible partial biodeg Time for complete ultimate aerobic biodeg $ mo

### Sorption to soils/sediments = strong PBT Potential: P2B1 *CEB FATE: Migration to ground water = negl

Health : Health Summary: Absorption is nil all routes for the neat material, while for the material in solution, absorption is poor all routes, based on physical/chemical properties. N o significant health concerns. Test Data: Submitted with :
Salmonella assay negative with and without activation; Rat oral LD50 > 2000 mg/kg; Rat dermal LD50 > 2000 mg/kg; Minimal eye irritant in rabbits; N ot a dermal irritant in female rabbits; N ot a dermal sensitizer in female guinea pigs; Repeated dose (gavage) tests in rats yielded no clinical signs of toxicity

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 0.43 or * daphnid 48-h LC50 0.41 or * green algal 96-h EC50 0.17 fish

_ chronic value 0.009 daphnid chronic value 0.070 algal

_ chronic value 0.030 Sewage Sludge 3-h EC50 Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = ; MW 397; solid with unknown mp (P); log Kow = 5.32 (EPI); S = 0.092 mg/L at 20 C (P); p H7; effective concentrations based on 100% active ingredients and mean measured concentrations; DW hardness < 150.0 mg/L as CaCO3; and DW TOC <2.0 mg/L;

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 1

SARs SAR Class

Ecotox Factors Comments:

# A-002 Initial Review Engineering Report

for PMN P-09-532

### INITIAL REVIEW ENGINEERING REPORT P-09-0532 Focus Ready Draft 8/17/2009

ENGINEER: Macek \ DDH PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

MSDS: N o LABEL : N o
Gen Eqpt: MSDS not included. TLV/PEL : - not available.

Consumer Use :
SAT (concerns): (8/11/2009):
Migration to groundwater: PBT rating: P 2 B 1 T 1

. Health: 1 Eco: 3, Water (All releases to surface water with a CC = 1 ppb )

OCCUPATIONAL EXPOSURE RATING: N R

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

P2 REC:

EXPOSURE -BASED REVIEW:P-09-0532



## 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. N ote that incineration and landfill are not required

Water or Incineration or Landfill Output 2: 1.1E+0 kg/site-day over 301 day/yr

Incineration Output 2: 1.1E+0 kg/site-day over 301 day/yr



## RELEASE TOTALP-09-0532



## 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. N ote that incineration and landfill are not required

Water or Incineration or Landfill Output 2: 2.6E-3 kg/site-day over 260 day/yr



## RELEASE TOTALP-09-0532



## 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: 7.7E+0 kg/site-day over 44 day/yr



## RELEASE TOTAL

# A-003 Initial Review Exposure Report

for PMN P-09-5328/14/2009 Page of

INITIAL REVIEW EXPO SURE REPORT (IRExR)

Chemical ID: P090532 Reviewer: Sherer
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 Acute Eco, PDM --- --- --- --- 247.43 43 --- --- --- --- --- max Acute Eco, PDM --- --- --- --- 35.35 186 --- --- --- --- --- max Acute Eco, PDM --- --- --- --- 0.61 13 --- --- --- --- ---
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?: (default is NA)8/14/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090532 Assessor: Sherer

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: max Acute Eco, 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:8/14/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090532

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

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY max Acute Eco, PDM

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 8.48 15.38 24.36 29.61

ALL 10 29.13 144.41 247.43 295.70

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 7.98E-06 2.74E-05 mg/kg/day 5.16E-05 1.77E-04 mg/kg/day

LADC pot 4.09E-04 1.40E-03 mg/L 0.62 2.12 mg/kg

Acute

ADR pot 1.29E-03 1.21E-02 mg/kg/day 2.30E-02 7.90E-02 mg/kg/day

SIC Code Comments:8/14/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090532

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 1 RELEASE ACTIVI TY: max Acute Eco, PDM

SIC CODE DESCRIPTION:

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

1.00 12 43 High

Remark: COC exceeded greater than 20 days per year.8/14/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090532 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites: Release Activity: max Acute Eco, 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:8/14/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090532

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY max Acute Eco, PDM

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 1.21 2.20 3.48 4.23

ALL 10 4.16 20.63 35.35 42.24

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 7.80E-06 2.68E-05 mg/kg/day 5.04E-05 1.73E-04 mg/kg/day

LADC pot 4.00E-04 1.37E-03 mg/L 0.60 2.07 mg/kg

Acute

ADR pot 1.84E-04 1.72E-03 mg/kg/day 3.29E-03 1.13E-02 mg/kg/day

SIC Code Comments:8/14/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090532

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY max Acute Eco, PDM

SIC CODE DESCRIPTION:

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

1.00 51 186 High

Remark: COC exceeded greater than 20 days per year.8/14/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090532 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: Release Activity: max Acute Eco, 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:8/14/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090532

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY max Acute Eco, PDM

SIC-CODE DESCRIPTION: POTW's (All facilities) SIC-CODE (S): 4952 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 5.18E-03 1.48E-02 2.43E-02 2.89E-02

ALL 10 11.11 1.94 1.06 0.96 5.85E-02 0.34 0.61 0.68

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 2.88E-08 3.25E-07 mg/kg/day 1.86E-07 2.10E-06 mg/kg/day

LADC pot 1.48E-06 1.67E-05 mg/L 2.23E-03 2.52E-02 mg/kg

Acute

ADR pot 1.23E-06 2.80E-05 mg/kg/day 1.40E-05 1.59E-04 mg/kg/day

SIC Code Comments:8/14/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090532

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 3 RELEASE ACTIVITY max Acute Eco, PDM

SIC CODE DESCRI PTION: POTW's (All facilities)

ASSOCIATED SIC CODES: 4952

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

1.00 4 13 High8/14/2009 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.