# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN)
P-09-61

EPA Docket EPA-HQ-OPPT-2010-1075

# Index
A-001 Structure Activity Team (SAT) Report for PMN P -09-61
A-002 Initial Review Engineering Report for PMN P -09-61
A-003 Initial Review Exposure Report for PMN P -09-61

# A-001 Structure Activity Team (SAT) Report
for PMN P-09-61

## SAT Report PMN Number: P-09-0061 SAT Date: 11/21/2008

Related cases : Health related cases: Ecotox related cases:

Concern levels : 

### Type of Concern: Health Eco Comments Level of Concern: 1 3 Health: ; Eco: chronic toxicity only

Persistence Bioaccum Toxicity Comments 2 1 1
Exposure Based Review : Health: N o Ecotox: Yes
Routes of exposure : Health: N o exposures needed Ecotox: All releases to water Fate: ;

P 2 Rec Comments : Comment: SAT had no comment
Keywords : Keywords:
Summary of Assessment :

Fate : Fate Summary: P-09-0061 FATE: Solid with MP = 194-196 EC (M) log Kow = -1.62 (M); S = 9.3 g/L at 25 EC (M) VP < 1.0E-6 torr at 25 EC (E) BP = Dec. 199 EC (M) H < 1.00E-8 (E) log Koc = 1.41 (E) log Fish BCF = 0.50 (E)

### POTW removal (%) = 0 Time for complete ultimate aerobic biodeg = mo Sorption to soils/sediments = low PBT Potential: P2B1 *CEB FATE: Migration to ground water = rapid

Health : Health Summary: N ot absorbed through the skin as the neat material, p oo r through the skin if in solution; moderate absorption from the GI tract and good absorption from the lung ( p che m ). N o significant health concerns. Test Data: (-) Salmonella with and without activation; (-) in all strains with activation; (-) E. coli with and without activation; (-) for chromosome aberrations in human peripheral blood lymphocytes; rat oral LD0 = 5000 mg/kg; (-) for skin sensitization in a mouse local lymph node assay

Ecotox :

Test Organism Test Type Test End Point Predicted Measured Comments

fish 96-h LC50 500 >120 Limit test; highest conc tested; N o LOEC daphnid 48-h LC50 160 >120 Limit test; highest conc tested; N o LOEC green algal 96-h EC50 750 >120 Limit test; highest conc tested; N o LOEC fish

_ chronic value 34/0.064 30-dy/60-day daphnid

_ chronic value 30 algal

_ chronic value 360 Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value

_ Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class MW 215; log Kow = 1.74 (EPI), -1.62 (M); p H7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;

P09-0061 EVALUATION OF ECOTOXICITY STUDIES For Friday, N ovembe r 21, 2008 FOCUS Evaluator: S. Cragg N ominal ECOSA R Concentration Predicted Test Type Function EvaluateParameter Measu(mg a.i./L)(a) Value (mg/L)
Acute Freshwater Fish Lethality 96-hr LC50 >120 500

### Zebra Fish LOEC >120 (Danio rerio) N OEC >120 static
Acute Freshwater Copepod Mobility 48-hr EC50 >120 160 (Daphnia magna) LOEC >120 static NOEC >120 "Limit Test"
Acute Freshwater Algae Growth Inhibition (Pseudokirchneriella subcapita Growth Rate† 72-hr ErC50 >120 750 LOEC >120 N OEC >120
Yield 0-72-hr EyC50 >120 LOEC >120 N OEC >120

ECOSAR fish chronic 34/0.064 ECOSAR daphnia ChV 30 ECOSAR algal ChV 360
(a) Value represents nominal values verified via analytical measurement (HPLC with UV detector). Agreement > 95%. † Concentration that reduced growth rate by 50%. †† Concentration that reduced yeild (cell density) by 50%.

Conclusion: Results from the three limit tests are considered valid. N o effects were detected (mortality, behavior, morphology, or growth) for fish, daphnia, or algae at the limit concentration of 120 mg/L. The concern concentration may be derived by dividing 120 mg/L by a factor of 10 to approximate a chronic value and then again by a second assessment (uncertainty) factor of 10 to yeild a concentration of concern (CoC) of 1.2 mg/L or 1,200 μg/L, rounded to 1,000 μg/L ( p pb). The PMN is of low concern for ecotoxicity.
Fish Daphnia Algae Test compound purity (%): 99.1 99.1 99.1 Temperature Range (°C): 21.0 - 22.5 18.1 - 18.4 24 O2 concentration (mg/L): 6.90 - 7.99 7.68 - 7.95 Water Hardness: 166 200 p H: 6.85 - 7.22 7.15 - 7.21 7.3 - 7.6 Conductivity 535 478 N ominal or Measured? N ominal* N ominal* N ominal* Flow-through/Static/Semi-stati Static Static Static Certificate of Analysis? Yes * with analytical confirmation

### Estimated Measured Physical State -- Solid Volatility (mmHg) 1.0E-06 -- Absorptivity (Log Koc) N /D -- Log Kow -- -1.62 Water Solubility (mg/L) -- 9,300 Henry's Law Constant 1.0E-08 -- Sorption to Soils low --

Factors Values Comments Assessment Factor 10 Concentration of Concern ( p pb) 6

SARs SAR Class

Ecotox Factors Comments:

SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report
for PMN P-09-61

### INITIAL REVIEW ENGINEERING REPORT P-09-0061 Focus Ready Draft 12/8/2008

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

Revision Notes/Assessment Overview:

SUBMITTER: DuPont Agricultural Caribe Industries, Ltd. (submitter)

USE: Chemical intermediate for an herbicide.

OTHER USES:

MSDS : LABEL :
Gen Eqpt:

Respirator :

Health Effects :

TLV/PEL :

CRSS: Chemical Name: S-H2O: VP: MW:

Consumer Use : N o
SAT (concerns):
Migration to groundwater: Rapid PBT rating: P 2 B 1 T 1Health: 1 Eco: 3, Water (All releases to water with a CC = 6 ppb),

OCCUPATIONAL EXPOSURE RATING: N R

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

POLLUTION PREVENTION CONSIDERATIONS: P2 Claim:

P2 REC:

EXPOSURE-BASED REVIEW:P-09-0061

## OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY Tot. # of workers exposed via assessed routes: Basis:

# A-003 Initial Review Exposure Report
for PMN P-09-6112/5/08 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)

Chemical ID: P090061 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 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

--- --- --- --- 2.41 --- --- --- --- --- --- --- --- --- --- 1.38 --- --- --- --- --- --- --- --- --- --- 2.38 3 --- --- --- --- ---

--- --- --- --- 1.36 --- --- --- --- --- --- 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:

Exposure Based Criteria

Parameter Drinking (Surface) Water Do se (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)12/5/08 Page of

INITIAL REVIEW EXPOSU RE REPORT (IRExR)

Summary Table: Endpoints assessed
Endpoints-Assessed Table Reasons for not assessing releases

Endpoints/Assessment Cycles 1 Releases Assessed in NCEM2? No XB Testing Required No Hazard Concern No Releases Release Below Acute Threshold 5 Release Below Chronic Threshold 5 Other

Ingestion Surface water N NA X Ground water (landfill) N NA X Consumer Use: DtD 2 N NA X Inhalation Air: incineration (stack) N NA X Air: fugitive N NA X Consumer Use: CEM 3 N NA X Dermal Consumer Use: CEM N NA Eco Surface water: ADR conc and/or PDM 4 Y NA

Consumer Use: DtD N NA

1 Assessment cycles are endpoint concentrations and dose calculations within the NCEM2 model. 2 Down-the-Drain Module 3 Consumer Exposure Module 4 Probabilistic Dilution Model 5 The threshold values for assessing endpoints are 1 mg/day for acute doses and 1 mg/year for chronic doses.

Remarks:12/5/08 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090061 Assessor: Sherer

ENVIRONMENTAL RELEASES

Scenario#:1 Number of Release Sites: Release Activity:
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:12/5/08 Page of

INITIAL EXPOSURE REVIEW REPORT

Chemical ID: P090061 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER:1 RELEASE AC TIVITY:

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) 0.67 1.77 2.41 3.03 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 1.44E-08 mg/kg/day 1.95E-10 mg/kg/day

LADC pot 7.37E-07 mg/L 2.33E-06 mg/kg

Acute

ADR pot 1.48E-04 mg/kg/day 3.82E-06 mg/kg/day

Surface Water Comments:12/5/08 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090061 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:2 Number of Release Sites: Release Activity:
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:12/5/08 Page of

INITIAL REVIEW EX POSURE REPORT

CHEMICAL ID: P090061

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES: LAKES, BAYS, ESTUARIES, AND OCEANS
SCENARIO #: 2 RELEASE ACTIVITY: FACILITY NAME: FACILITY LOCATION: RECEIVING WATER NAME: REACH NUMBER: FACILITY ON REACH: DISCHARGE TYPE: NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PLANT FLOW (MLD) PRETREAT RELEASE (kg/site/day) POST-TREAT RELEASE (kg/site/day) BCF (L/kg)

AQUATIC EXPOSURE ESTIMATES MIXING ZONE DILUTION FACTOR WATER CONCENTRATION (ug/L) ACUTE SCENARIO 1.38 CHRONIC SCENARIO 1.38

FISH INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (g/day) Cancer LADD pot (mg/kg/day) 3.99E-10 30.00 75.00 71.80 6.00 LADC pot (mg/kg) 4.77E-06 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 7.83E-06 NA 1 day 71.80 129.00 Lakes Comments:12/5/08 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090061 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:3 Number of Release Sites: Release Activity:
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:12/5/08 Page of

INITIAL EXPOSURE REVIEW REPORT

Chemical ID: P090061 SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER:3 RELEASE ACTIVITY:

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) 0.66 1.75 2.38 2.98 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 1.98E-06 mg/kg/day 2.68E-08 mg/kg/day

LADC pot 1.02E-04 mg/L 3.21E-04 mg/kg

Acute

ADR pot 1.46E-04 mg/kg/day 3.76E-06 mg/kg/day

Surface Water Comments:12/5/08 Page of

INITIAL REVIEW EX POSURE REPORT Chemical ID: P090061

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES

SCENARIO NUMBER: 3 RELEASE ACTIVITY:

FACILITY NAME:

FACILITY LOCATION:

RECEIVING STREAM NAME:

REACH NUMBER: FACILITY ON REACH: DISCHARGE TYPE:

NPDES PERMIT NUMBER: GAGING STATION ID:
GAGING STATION PERIOD OF RECORD: N/A GAGING STATION NUMBER OF OBSERVATIONS: NUMBER OF STATIONS ON REACH:

MEAN FLOW (MLD): 7q10 FLOW (MLD): EFFLUENT FLOW (MLD)

RESULTS

COC ( μ g/L) Percent of Year COC Exceeded Number of Days COC Exceeded Release days/year Pre-treatment Loading (kg/site/day) Waste Water Treatment (%)

6.00 1 3 140.0012/5/08 Page of

INITIAL REVIEW EXPOSURE REPORT

Chemical ID: P090061 Assessor:

ENVIRONMENTAL RELEASES

Scenario#:4 Number of Release Sites: Release Activity:
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:12/5/08 Page of

INITIAL REVIEW EX POSURE REPORT

CHEMICAL ID: P090061

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES: LAKES, BAYS, ESTUARIES, AND OCEANS
SCENARIO #: 4 RELEASE ACTIVITY: FACILITY NAME: FACILITY LOCATION: RECEIVING WATER NAME: REACH NUMBER: FACILITY ON REACH: DISCHARGE TYPE: NPDES PERMIT #: EXPOSED POPULATION: Adult

WWT REMOVAL (%) RELEASE DAYS PLANT FLOW (MLD) PRETREAT RELEASE (kg/site/day) POST-TREAT RELEASE (kg/site/day) BCF (L/kg)

AQUATIC EXPOSURE ESTIMATES MIXING ZONE DILUTION FACTOR WATER CONCENTRATION (ug/L) ACUTE SCENARIO 1.36 CHRONIC SCENARIO 1.36

FISH INGESTION EXPOSURE ESTIMATES ASSUMPTIONS Exposure Units Results ED (years) AT (years) BW (kg) IR (g/day) Cancer LADD pot (mg/kg/day) 5.50E-08 30.00 75.00 71.80 6.00 LADC pot (mg/kg) 6.58E-04 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 7.70E-06 NA 1 day 71.80 129.00 Lakes Comments:12/5/08 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.