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

P-09-234

EPA Docket EPA-HQ-OPPT-2010-1075

# Index

A-001 Structure Activity Team (SAT) Report for PMN P-09-234

A-002 Initial Review Engineering Report for PMN P-09-234

A-003 Initial Review Exposure Report for PMN P-09-234

# A-001 Structure Activity Team (SAT) Report

for PMN P-09-234

## SAT Report PMN Number: P-09-0234 SAT Date: 2/27/2009

Related cases : Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 2 2

Persistence Bioaccum Toxicity Comments 1 1 1
Exposure Based Review : Health: N o Ecotox: Yes

Routes of exposure : Health: Dermal, inhalation Ecotox: All releases to water Fate: ;

P 2 Rec Comments : Comment: SAT had no comment

Keywords : Keywords: EYE; LUNG; IRR-E,S,MM; AQUATOX
Summary of Assessment :

Fate : Fate Summary: P-09-0234 FATE: Estimations for typical n=2 Liquid with MP < 25 EC (E) log Kow = 2.52 (E); S = Disp./349 mg/L at 25 EC (ICB/E) VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E) H < 1.00E-8 (E) log Koc = 2.90 (E) log Fish BCF = 1.33 (E)

### POTW removal (%) = 50-90 via sorption Time for complete ultimate aerobic biodeg = wk Sorption to soils/sediments = moderate - strong PBT Potential: P1B1 *CEB FATE: Migration to ground water = slow - moderate

Health : Health Summary: Absorption is poor from the skin, moderate from the GI tract, and good from the lung (analog). Concern for effects on the lung; irritation to eye, skin (chronic), mucous membranes and lung based on properties of the compounds. As a the PMN substance may anesthetize the eye allowing considerable damage before anything is noticed.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 2.8 daphnid 48-h LC50 2.8 green algal 96-h EC50 2.8 fish

_ chronic value 0.56 daphnid chronic value 0.56 algal

_ chronic value 0.70 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = p H7; effective concentrations based on 100% active ingredients and mean measured concentrations ; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 56

SARs

SAR Class

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report

for PMN P-09-234

### INITIAL REVIEW ENGINEERING REPORT P-09-0234 Focus Ready Draft 3/5/2009

ENGINEER: Prothero \ JAS PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER:

USE:

OTHER USES:

SAT (concerns): (2/27 /2009 ):

Migration to groundwater: Slow to moderate PBT rating: P 1 B 1 T 1 Health: 2, Dermal, Inhalation Eco: 2, Water (All releases to water with a CC = 56 ppb ),

OCCUPATIONAL EXPOSURE RATING: 1B

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

POLLUTION PREVENTION CONSIDERATIONS:P2 REC:P-09-0234

.P-09-0234

# A-003 Initial Review Exposure Report

for PMN P-09-2343/4/2009 Page of

INITIAL REVIEW EXPOSURE REPORT (IRExR)

Chemical ID: P090234 Reviewer: Sherer/Kwon

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 CC=56 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 --- --- --- --- 1.89E+04

--- --- --- --- --- ---

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.

Remarks:

Results Table: Exposure Based (XB)/Persistent (P2B2) Criteria

Parameter Drinking (Surface) Wate r Dose (mg/kg/day) Fish Ingestion Dose (mg/kg/day) Inhalation Dose (mg/kg/day) Groundwater Dose (mg/kg/day) Surface Water Release After Treatment (kg/yr) Total Release After Treatment (kg/yr) Consumer Use?

Fate test recommendations?:3/4/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090234 Assessor: Sherer/Kwon

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity: 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:3/4/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090234

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY max Acute Eco

EX PO SED 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 22.53 159.29 454.34 746.27 887.71

ALL 10 11.11 1.94 1.06 0.96 1800.18 1.03E+04 1.89E+04 2.08E+04

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 3.40E-06 3.85E-05 mg/kg/day 3.12E-07 3.53E-06 mg/kg/day

LADC pot 1.75E-04 1.97E-03 mg/L 3.74E-03 4.22E-02 mg/kg

Acute

ADR pot 3.80E-02 0.86 mg/kg/day 6.12E-03 6.92E-02 mg/kg/day3/4/2009 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.