# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-09-388

EPA Docket EPA-HQ-OPPT-2010-1075

# Index
A-001 Structure Activity Team (SAT) Report for PMN P-09-388
A-002 Initial Review Engineering Report for PMN P-09-388
A-003 Initial Review Exposure Report for PMN P-09-388

# A-001 Structure Activity Team (SAT) Report
for PMN P-09-388

## SAT Report PMN Number: P-09-0388 SAT Date: 6/12/2009

Related cases : Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1-2 2

Persistence Bioaccum Toxicity Comments 3 1 1 Exposure Based Review : Health: N o Ecotox: Yes Routes of exposure : Health: Inhalation Ecotox: All releases to water Fate: ; Keywords : Keywords: IMMUNOTOX; MUTA; SENS-L; AQUATOX Summary of Assessment :
Fate : Fate Summary: P-09-0388 FATE: MW = 1500 with 0.5% < 500 and 1.5% < 1000 Solid S > 10 g/L at 25 C (ICB) VP < 1.0E-6 torr at 25 EC (E) BP > 400 EC (E) H < 1.00E-8 (E) POTW removal (%) = 0 Time for complete ultimate aerobic biodeg > mo Sorption to soils/sediments = low - moderate PBT Potential: P3B1 *CEB FATE: Migration to ground water = moderate

Health :

### Health Summary: N ot absorbed through the skin. Polymer: p oor absorption from the GI tract and moderate absorption from the lung ( p che m ); absorbed from the lung and GI tract (analog). Concern for the are as follows: : immunotoxicity and mutagenicity; mutagenicity and respiratory sensitization; and immunotoxicity, mutagenicity, and respiratory sensitization.

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 160 daphnid 48-h LC50 15 green algal 96-h EC50 1.4 fish

_ chronic value 8.8 daphnid

_ chronic value 2.7 algal

_ chronic value 0.34 Sewage Sludge 3-h EC50

_ Sewage Sludge Chronic Value
Ecotox Values Comments: Predictions are based on SARs for compounds; SAR chemical class = solid with unknown mp (P); S > 400 g/L in water at 20 °C (M); p H7; 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 ( p pb) 34

SARs SAR Class
Ecotox Factors Comments:
SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report
for PMN P-09-388

### INITIAL REVIEW ENGINEERING REPORT P-09-0388 Focus Ready Draft 6/18/2009

ENGINEER: Arnold \ CLM PV (kg/yr):

Revision Notes/Assessment Overview:

SUBMITTER: Specialty Fertilizer LLC (submitter)

USE:

MSDS: N o LABEL : N o

Consumer Use : SAT (concerns): (6/12/2009):

Related Cases and Misc SAT Info: Ecotox Related Cases: Migration to groundwater : Moderate PBT rating: P 3 B 1 T 1 - Health: 1-2, Inhalation Eco: 2, Water (All releases to water with a CC = 34 ppb)

OCCUPATIONAL EXPOSURE RATING: 2-3B

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

P2 REC:

EXPOSURE -BASED REVIEW:P-09-0388P-09-0388P-09-0388

# A-003 Initial Review Exposure Report
for PMN P-09-3886/17/2009 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)

Chemical ID: P090388 Reviewer: Flessner
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=34 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, max ADR --- --- --- --- 4.90E+04 --- --- 5.88E-02 --- --- --- max Acute Eco, PDM --- --- --- --- 695.88 92 --- --- --- --- --- max Acute Eco, PDM --- --- --- --- 6.32E+04 100 --- --- --- --- ---
max LADD --- --- --- --- --- --- --- --- 2.25E-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. 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?:6/17/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090388 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:6/17/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090388

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

SCENARIO #: 1 Number of Site s: RELEASE ACTIVITY : max ADR, max Acute Eco SIC-CODE DESCRIPTION: POTW (Indust., incl udes POTWs which receive ind. disch.) 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 50 288.00 123.84 78.18 66.05 1319.44 3068.48 4860.58 5753.22
ALL 10 39.60 13.29 7.76 7.57 9595.96 2.86E+04 4.90E+04 5.02E+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 1.97E-04 1.44E-03 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 1.01E-02 7.36E-02 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 0.26 2.39 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:6/17/2009 Page of

INITIAL EXPOSURE REVIEW REPORT Chemical ID: P090388

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 1 RELEASE ACTIVITY max ADR, max Acute Eco
RELEASE DESCRIPTION:
METHOD OF CALCULATION: Screen3
EXPOSED POPULATION: Adult

Number of Sites: Per Site Fugitive Release: NA kg/site/day Fugitive Release Days per Year: NA days % Removal via Fugitive Release: 0.00 % Total Fugitive Release: NA kg/yr Max Annual Average Air Concentration (Fugitive): 0.00 μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): 0.00 μg/m 3

Per Site Stack Release: kg/site/day Stack Release Days per Year: days
% Removal via Stack Release: %
Total Stack Release: kg/yr Max Annual Average Air Con centration (Stack): 1.21 μg/m 3 Max 24 Hour Average Air Concentration (Stack): 320.00 μg/m 3

ASSUMPTIONS Exposure Units Results (Stack) Results (Fugitive) ED (years) AT (years) BW (kg) Inh. Rate (m 3 /hr)
Cancer
LADD pot (mg/kg/day) 8.90E-05 N/A 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) 4.84E-04 N/A 30.00 75.00 NA NA
Acute
ADR pot

(mg/kg/day) 5.88E-02 N/A NA 1 day 71.80 0.55

Inhalation Comments:6/17/2009 Page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 m Release Height: N/A
Inside Stack Diameter: 0.10 m Length of Release Opening: N/A

Stack Gas Exit Velocity: 0.10 m/sec Width of Release Opening: N/A

Stack Gas Temperature: 293.00 K

Meteorological and Terrain Information:
Surrounding Land Use: Rural Terrain Height: 0.00 m
Distance to Residence of Interest: 100.00 m Meteorological Class: Full Stability Class: NA Wind Speed: NA

Downwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m6/17/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090388 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:6/17/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090388

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: POTW (Indust., incl udes POTWs which receive ind. disch.) 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 50 288.00 123.84 78.18 66.05 18.75 43.60 69.07 81.76
ALL 10 39.60 13.29 7.76 7.57 136.36 406.32 695.88 713.34

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 4.01E-05 2.91E-04 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 2.05E-03 1.49E-02 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 3.64E-03 3.40E-02 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:6/17/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090388

SIC CODE EXPOSURES TO SURFACE WATER RELEASES

SCENARIO #: 2 RELEASE ACTIVITY max Acute Eco, PDM SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.)
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

34.00 25 92 High

Remark: COC exceeded great er than 20 days/year.6/17/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090388 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:6/17/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090388

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

SCENARIO #: 3 Number of Site s 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 22.53 533.61 1522.04 2500.00 2973.81
ALL 10 11.11 1.94 1.06 0.96 6030.60 3.45E+04 6.32E+04 6.98E+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 1.14E-03 1.29E-02 mg/kg/day 0.00 0.00 mg/kg/day
LADC pot 5.85E-02 0.66 mg/L 0.00 0.00 mg/kg
Acute
ADR pot 0.13 2.89 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:6/17/2009 Page of

INITIAL REVIEW EX POSURE REPORT

Chemical ID: P090388

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

34.00 27 100 High

Remark: COC exceeded great er than 20 days/year.6/17/2009 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090388 Assessor:
ENVIRONMENTAL RELEASES
Scenario#:4 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:6/17/2009 Page of

INITIAL EXPOSURE REVIEW REPORT Chemical ID: P090388

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT)

SCENARIO #: 4 RELEASE ACTIVITY:Use: max LADD
RELEASE DESCRIPTION:
METHOD OF CALCULATION: Screen3
EXPOSED POPULATION: Adult

Number of Sites: Per Site Fugitive Release: NA kg/site/day Fugitive Release Days per Year: NA days % Removal via Fugitive Release: 0.00 % Total Fugitive Release: NA kg/yr Max Annual Average Air Concentration (Fugitive): 0.00 μg/m 3

Max 24 Hour Average Air Concentration(Fugitive): 0.00 μg/m 3

Per Site Stack Release: kg/site/day Stack Release Days per Year: days
% Removal via Stack Release: %
Total Stack Release: kg/yr Max Annual Average Air Con centration (Stack): 3.06 μg/m 3

ASSUMPTIONS Exposure Units Results (Stack) Results (Fugitive) ED (years) AT (years) BW (kg) Inh. Rate (m 3 /hr)
Cancer
LADD pot (mg/kg/day) 2.25E-04 N/A 30.00 75.00 71.80 0.55
LADC pot (mg/m 3 ) 1.22E-03 N/A 30.00 75.00 NA NA

Inhalation Comments:6/17/2009 Page of

Stack Parameter Data Fugitive Parameter Data Stack Height 10.00 m Release Height: N/A
Inside Stack Diameter: 0.10 m Length of Release Opening: N/A

Stack Gas Exit Velocity: 0.10 m/sec Width of Release Opening: N/A

Stack Gas Temperature: 293.00 K

Meteorological and Terrain Information:
Surrounding Land Use: Rural Terrain Height: 0.00 m
Distance to Residence of Interest: 100.00 m Meteorological Class: Full Stability Class: NA Wind Speed: NA

Downwash Information:
Facility Length: NA m Facility Width: NA m Facility Height: NA m6/17/2009 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.