Support Documents for 

Significant New Use Rules (SNUR) on 

Premanufacture Notices (PMN) 

P-10-358 

EPA Docket EPA-HQ-OPPT-2012-0182 

EPA SANITIZED Page 1 of 101
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-10-358 

A-002 Initial Review Engineering Report for 

 PMN P-10-358 

A-003 Initial Review Exposure Report for 

 PMN P-10-358 

A-004 TSCA Section 5(e) Consent Order and 

Determinations Supporting Consent Order for 

PMN P-10-358 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-10-358 

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SAT Report

PMN Number: P-10-0358

SAT Date: 5/7/2010

Print Date: 12/7/2011

Related cases: CBI: Yes

Health related cases: Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 2-3 2

 Persistence Bioaccum Toxicity Comments

3 12

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Dermal Drinking Water Inhalation 

Ecotox: All releases to water

Fate: ;

P2Rec Comments:

Comment: P2REC: SAT: Do not forward. While is desirable, the PM

a very low NOAEL of 5 mg/kg in a rat 28-day oral study.

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Keywords:

 Keywords: BLOOD; LYMPH; NEURO; MUTA; ACUTE-EYE; SENS-S; IMMUNOTOX (UNC

Summary of Assessment:

 Fate:

Fate Summary: 

FATE: Estimations for log Kow = -0.13 (E)log Koc = 2.94 (E)log Fish BCF = 0.50 (E)log Fish BAF = -0.04 (E)H < 1.00E-8 (E)POTW removal (%) = 90 via sorption; OECD 301B (CO2 Ev): 2.3%/28d. NRB. OECD 111: t1/2(ph 4,7,9): >1 

Time for complete ultimate aerobic biodeg > moSorption to soils/sediments = v.strongPBT Potential: P3B1*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Expect poor absorption via all routes (pchem). Concern for blood and lym

neurotoxicity; mutagenicity; acute toxicity (eye and oral); and dermal sensitization. Uncertain concern for immu(8.5% of PMN substance) at high doses.

 Test Data: (-) Salmonella with and without activation; (-) oral mouse micronucleus a

chromosome aberrations in human lymphocytes without activation after 20 hour exposure but not after 17 hour eoral LD50 >200 mg/kg <300 mg/kg; rat dermal LD0 = 2000 mg/kg; no eye irritation in surviving rabbits, howevwithin 1 hour of treatment; no skin irritation in rabbits; Mice died in the first local lymph node assay (Solvent; Denhancer) 1 @ 25% after 1 application, 1 @ 5%, 2 @ 20%, and 4 @ 25% after 2 applications; (+) for skin sensit

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local lymph node assay at 0.25, 0.5 and 1% ai (solvent: DMF); no skin sensitization in guinea pigs using the Bue

ai in water; rat 28-day oral NOEL = 5 mg/kg, signs of neurotoxicity, and blood and lymph system toxicity at 50 a7-day range finding NOEL = 100 mg/kg, at 1000 mg/kg 3/4 died and the fourth was killed in extremis

: In the eye irritation study 2/4 rabbits died

 Ecotox:

Test 

Organism

Test 

Type

Test End Point

Predicted Measured C

fish 96-h LC50 >1000 >100

daphnid 48-h LC50 230 23.7

green algal 96-h EC50 96 5.15 for biom

fish 

_

chronic value >100

daphnid

_

chronic 

value

20

algal 

_

chronic 

value

26

Sewage 

Sludge

3-h EC50

_

>1000 3hrEC20=264; 

Sewage 

Sludge

_

Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical cla

; MW 660; 

pH7; effective concentrations based on 100% active ingredients and mean m

concentrations; hardness <180.0 mg/L as CaCO3; and TOC <2.0 mg/L;Ecotoxicity studies accompanied this PMN. The studies were evaluated for validity and derivation of a concern Conclusions are quoted below. Complete details are provided in the attached spreadsheet (Ecotox Report).All tests are considered valid. The fish toxicity test showed no effects at a concentration of 100 mg/L. Daphnia EC50 of 24 mg/L. In the respiratory inhibition test, the highest concentration of 1000 mg/L caused less than 50% measured by oxygen consumption) so the effective concentration that caused 20% inhibition (EC20) was calcula

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value was 265 mg/L. The EC15 is defined as the NOEC by OECD guideline 209 and was 174 mg/L with 95% C

mg/L. The most sensitive species was algae where the 72-hour EbC50 was 5.15 mg/L for inhibition of biomass. concentration (CC) is derived from this value by dividing 5.15 mg/L by an acute to chronic ratio of 4 to simulate then dividing again by an assessment (uncertainty) factor of 10, yielding a CC of 129 mg/l (

ppb). The PMN is m

Factors Values Comments

Assessment Factor 10

Concentration of Concern (

ppb) 129 from algae study

SARs

SAR Class

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

 for PMN P-10-358 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0358

Focus Ready Draft 5/13/2010

ENGINEER: Avcin \ AH

PV (kg/yr): 

SUBMITTER: 

USE: 

 

 

 

 

OTHER USES:

 

CRSS :

Chemical Name:

 

 

Consumer Use: 

Page 1

EPA SANITIZED Page 9 of 101
SAT (concerns) (01/15/2010):

Migration to groundwater: Negligible

PBT rating: P3B1T2

Health: 2-3 Dermal, Drinking Water, Inhalation

Eco: 2 Water (All releases to water with a CC = 129 ppb),

All releases to Water

OCCUPATIONAL EXPOSURE RATING: 1-2C

NOTES & KEY ASSUMPTIONS:

Generated by the 06/07/2005 version of ChemSTEER. 

 

 

 

 

 

 

 

 

 

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

 

Page 2

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EXPOSURE-BASED REVIEW: No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0358

Number of Sites/ Location: 1

unknown site in Franklin PA

Days/yr: 16

Process Description:

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

High End: 3.8E-1 kg/site-day over 16 days/yr from 1 site

or 6.1E+0 kg/yr

to: 

from:

 

 

RELEASE TOTAL

6.1E+0 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 3

Inhalation:

negligible (VP < 0.001 torr)

Dermal:

Exposure to Liquid at 1.00% concentration

High End: 1.8E+1 mg/day over 16 days/yr

Number of workers (all sites) with dermal exposure: 3

INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0358

Processing: 

Page 3

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Number of Sites/ Location: 15

unknown sites

Days/yr: 52

Process Description:

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. Submitter has no information on the

method of waste disposal; CEB assesses potential release

to uncertain media. Note incineration release < 28,000

kg/site-day and release to land is not required per SAT.

Water or Incineration or Landfill

Conservative: 7.7E-2 kg/site-day over 52 days/yr from 15

sites

or 6.0E+1 kg/yr

Water or Incineration or Landfill

High End: 1.2E-1 kg/site-day over 52 days/yr from 15 sites

or 9.0E+1 kg/yr

RELEASE TOTAL

1.5E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 45

Inhalation:

negligible (VP < 0.001 torr)

Dermal:

Exposure to Liquid at 1.00% concentration

High End: 1.8E+1 mg/day over 52 days/yr

Number of workers (all sites) with dermal exposure: 45

INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0358

Page 4

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Use: 

Number of Sites/ Location: 18

unknown sites

Days/yr: 250

 

Process Description: 

 

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. Releases from container and equipment

cleaning assessed to uncertain media; consistent with

similar use past case P08-0208.

Water or Incineration or Landfill

High End: 3.0E-3 kg/site-day over 250 days/yr from 18

sites

or 1.4E+1 kg/yr

Water or Incineration or Landfill

Conservative: 5.0E-3 kg/site-day over 250 days/yr from 18

sites

or 2.2E+1 kg/yr

RELEASE TOTAL

3.6E+1 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 54

Inhalation:

Exposure to Particulate (Class I)

Upper Bound: 1.5E-2 mg/day over 250 days/yr

Number of workers (all sites) with inhalation exposure: 54

Page 5

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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? No

 OR

 b) Hazard Rating for health of 2 or greater? 2-3 Yes

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Liquid at 0.01% concentration

High End: 1.8E-1 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 54

INITIAL REVIEW ENGINEERING REPORT 

PMN: 10-0358

Use 2: 

Number of Sites/ Location: 6

unknown sites

Days/yr: 235

Process Description: 

 

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

Output 2: 3.8E-2 kg/site-day over 235 days/yr from 6 sites

Water or Incineration or Landfill

High End: 3.2E-3 kg/site-day over 235 days/yr from 6 sites

or 4.5E+0 kg/yr

Page 6

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Water or Incineration or Landfill

Conservative: 1.1E-2 kg/site-day over 235 days/yr from 6

sites

or 1.5E+1 kg/yr

Air

Output 2: 1.6E-2 kg/site-day over 235 days/yr from 6 sites

Landfill

Output 2: 3.4E-1 kg/site-day over 235 days/yr from 6 sites

or 4.9E+2 kg/yr

RELEASE TOTAL

5.8E+2 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 102

Inhalation:

Exposure to Mist (non-volatile) (Class I)

What-If: 9.2E-3 mg/day over 235 days/yr

Number of workers (all sites) with inhalation exposure:

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? No

 OR

 b) Hazard Rating for health of 2 or greater? 2-3 Yes

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Liquid at 0.01% concentration

High End: 1.8E-1 mg/day over 235 days/yr

Number of workers (all sites) with dermal exposure: 102



Page 7

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MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: Ariel Hou

Organization: ERG

CALL TO: Joseph Plamondon

Organization: 

Date: 01/19/2010

Time: 11:30AM

Phone: 

Concerning what TSCA CBI?

PMN: 10-0358

 

MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: Joe Avcin

Organization: EPA

CALL TO: Joseph Plamondon

Organization: 

Date: 03/01/2010

Time:

Page 8

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Phone: 520-572-3948

Concerning what TSCA CBI?

PMN: 10-0358

 

Page 9

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A-003 

Initial Review Exposure Report 

 for PMN P-10-358 

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7/27/10 Page 1 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 Reviewer: 

 

 

Results Table: Dose, Concentration, and Days Exceeded Results Summary 

Exposure Scenario1 Water Landfill Stack Air Fugitive Air 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 7Q104 

CC = 129 

PDM 

Days 

Exceede

d 

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 μg/l # Days mg/kg/day mg/kg/day mg/kg/day mg/kg/day mg/kg/day 

Repackaging: Max 

ADR: max acute eco 

3.02E-05 --- 5 .35E-07 --- 5.50E-01 --- --- --- --- --- --- 

Repackaging: Max 

LADD 

--- 3 .22E-08 --- 4 .36E-10 --- --- --- --- --- --- --- 

PROC: Max ADR: 

max acute eco 

4.28E-04 --- 1 .03E-05 --- 8.78E+00 --- --- --- --- --- --- 

PROC: PDM1 --- --- --- --- 8.78E+00 0 --- --- --- --- --- 

PROC: Max LADD --- 2 .01E-06 --- 2 .72E-08 --- --- --- --- --- --- --- 

USE1: Max ADR: 

max acute eco 

3.45E-05 --- 4 .09E-07 --- 7.50E-01 --- --- --- --- --- --- 

USE1: PDM1 --- --- --- --- 7.50E-01 0 --- --- --- --- --- 

USE1: Max LADD --- 3 .85E-07 --- 5 .21E-09 --- --- --- --- --- --- --- 

USE2: Max ADR: 

max acute eco 

5.01E-05 --- 2 .13E-06 --- 1.04E+00 --- --- --- --- --- --- 

USE2: PDM1 --- --- --- --- 1.04E+00 0 --- --- --- --- --- 

USE2: Max LADD --- 1 .99E-06 --- 2 .69E-08 --- --- --- --- --- --- --- 

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 

2 Release activities are from engineering report's Manufacturing (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 daily 

streamflow of the seven consecutive days of lowest flow within a ten year period. 

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Results Table: Consumer Exposure Results Summary 

 Water (DtD) Dermal Inhalation 

Drinking Water Fish Ingestion 

ADR LADD ADR LADD 7Q10 PDM 

Days 

Exceede

d 

ADR LADD ADR LADD 

Scenario mg/kg/da

y 

mg/kg/da

y 

mg/kg/da

y 

mg/kg/da

y 

μg/l # Days mg/kg/d

ay 

mg/kg/d

ay 

mg/kg/d

ay 

mg/kg/da

y 

CEM2, --- --- --- --- --- --- --- --- 1 .39E-04 1.60E-07 

CEM2, --- --- --- --- --- --- 5.13E-03 8. 25E-06 4.98E-05 1.25E-06 

1 Down-the-Drain Module within NCEM2 model. 

2 Consumer Exposure Module within NCEM2 model.

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 1. 

 Release Activity: Repackaging: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 19.20 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 16.00 0.00/0.00 N/A N/A 

Per Site Release: 1.20 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER:1 RELEASE ACTIVITY: Repackaging: Max ADR 

FACILITY NAME: 

FACILITY LOCATION: FRANKLIN PA 16323 

RECEIVING WATER NAME: FRENCH CR 

REACH NUMBER: 05010004001 FACILITY ON REACH: No DISCHARGE TYPE: Direct 

NPDES PERMIT #: PA0002038 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90. 16. 1.2 0.12 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 1274.52 332.11 217.08 177.34 NA 

CONCENTRATION (μg/L) 9.42E-02 0.36 0.55 0.68 NA 

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water 

Results 

Drinking Water 

Units 

Fish Ingestion 

Results 

Fish Ingestion 

Units 

Cancer 

LADDpot 3.22E-08 mg/kg/day 4.36E-10 mg/kg/day 

LADCpot 1.65E-06 mg/L 5.22E-06 mg/kg 

Acute 

ADRpot 3.02E-05 mg/kg/day 5.35E-07 mg/kg/day 

Surface Water Comments: 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 1. 

 Release Activity: Repackaging: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 19.20 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 1.00 0.00/0.00 N/A N/A 

Per Site Release: 19.20 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

SITE-SPECIFIC HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO NUMBER:2 RELEASE ACTIVITY: Repackaging: Max LADD 

FACILITY NAME: 

FACILITY LOCATION: FRANKLIN PA 16323 

RECEIVING WATER NAME: FRENCH CR 

REACH NUMBER: 05010004001 FACILITY ON REACH: No DISCHARGE TYPE: Direct 

NPDES PERMIT #: PA0002038 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90. 1. 19.2 1.92 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

FLOW DESCRIPTOR Harmonic Mean 30Q5 7Q10 1Q10 PLANT 

FLOW (MLD) 1274.52 332.11 217.08 177.34 NA 

CONCENTRATION (μg/L) N/A N/A N/A N/A NA 

DRINKING WATER INGESTION AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water 

Results 

Drinking Water 

Units 

Fish Ingestion 

Results 

Fish Ingestion 

Units 

Cancer 

LADDpot 3.22E-08 mg/kg/day 4.36E-10 mg/kg/day 

LADCpot 1.65E-06 mg/L 5.22E-06 mg/kg 

Acute 

ADRpot N/A mg/kg/day N/A mg/kg/day 

Surface Water Comments: 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 15. 

 Release Activity: PROC: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 499.20 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 52.00 0.00/0.00 N/A N/A 

Per Site Release: 0.64 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 3 Number of Sites: 15 RELEASE ACTIVITY:PROC: 

Max ADR 

SIC-CODE DESCRIPTION: 

SIC-CODE (S) EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 52. 0.64 6.40E-02 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 216.47 60.31 37.13 30.71 0.30 1.06 1.72 2.08 

ALL 10 35.44 12.51 7.29 6.10 1.81 5.12 8.78 10.49 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 3.29E-07 2.01E-06 mg/kg/day 4.45E-09 2.72E-08 mg/kg/day 

LADCpot 1.68E-05 1.03E-04 mg/L 5.32E-05 3.25E-04 mg/kg 

Acute 

ADRpot 8.87E-05 4.28E-04 mg/kg/day 1.68E-06 1.03E-05 mg/kg/day 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor

ENVIRONMENTAL RELEASES 

 Scenario#:4 Number of Release Sites: 15. 

 Release Activity: PROC: PDM1 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 499.20 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 52.00 0.00/0.00 N/A N/A 

Per Site Release: 0.64 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 4 Number of Sites: 15 RELEASE ACTIVITY:PROC: 

PDM1 

SIC-CODE DESCRIPTION: 

SIC-CODE (S) EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 52. 0.64 6.40E-02 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 216.47 60.31 37.13 30.71 0.30 1.06 1.72 2.08 

ALL 10 35.44 12.51 7.29 6.10 1.81 5.12 8.78 10.49 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 3.29E-07 2.01E-06 mg/kg/day 4.45E-09 2.72E-08 mg/kg/day 

LADCpot 1.68E-05 1.03E-04 mg/L 5.32E-05 3.25E-04 mg/kg 

Acute 

ADRpot 8.87E-05 4.28E-04 mg/kg/day 1.68E-06 1.03E-05 mg/kg/day 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 4 RELEASE ACTIVITY: PROC: PDM1 

SIC CODE DESCRIPTION

ASSOCIATED SIC CODES: 

SIC CODE RESULTS 

COC (μg/L) 

Percent of 

Year COC 

Exceeded 

Number of 

Days COC 

Exceeded 

Release 

days/year 

Loading 

(kg/site/day) 

Waste Water 

Treatment (%) 

High/Avg 

Analysis 

129.00 0 0 52.00 0.64 90.00 High 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:5 Number of Release Sites: 15. 

 Release Activity: PROC: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 499.20 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 1.00 0.00/0.00 N/A N/A 

Per Site Release: 33.28 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 30 of 101
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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 5 Number of Sites: 15 RELEASE ACTIVITY:PROC: 

Max LADD 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 1. 33.28 3.33 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 216.47 60.31 37.13 30.71 N/A N/A N/A N/A 

ALL 10 35.44 12.51 7.29 6.10 N/A N/A N/A N/A 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 3.29E-07 2.01E-06 mg/kg/day 4.45E-09 2.72E-08 mg/kg/day 

LADCpot 1.68E-05 1.03E-04 mg/L 5.32E-05 3.25E-04 mg/kg 

Acute 

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day 

EPA SANITIZED Page 31 of 101
7/27/10 Page 14 of 33 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:6 Number of Release Sites: 60. 

 Release Activity: USE1: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 120.00 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 250.00 0.00/0.00 N/A N/A 

Per Site Release: 8.00E-03 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 32 of 101
7/27/10 Page 15 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 6 Number of Sites: 60 RELEASE ACTIVITY:USE1: 

Max ADR 

SIC-CODE DESCRIPTION: 

SIC-CODE (S) EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 250. 0.008 8.00E-04 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 125.56 44.02 26.80 22.53 6.37E-03 1.82E-02 2.99E-02 3.55E-02

ALL 10 11.11 1.94 1.06 0.96 7.20E-02 0.41 0.75 0.83 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 3.40E-08 3.85E-07 mg/kg/day 4.61E-10 5.21E-09 mg/kg/day 

LADCpot 1.75E-06 1.97E-05 mg/L 5.52E-06 6.23E-05 mg/kg 

Acute 

ADRpot 1.52E-06 3.45E-05 mg/kg/day 3.62E-08 4.09E-07 mg/kg/day 

EPA SANITIZED Page 33 of 101
7/27/10 Page 16 of 33 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:7 Number of Release Sites: 60. 

 Release Activity: USE1: PDM1 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 120.00 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 250.00 0.00/0.00 N/A N/A 

Per Site Release: 8.00E-03 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

 

EPA SANITIZED Page 34 of 101
7/27/10 Page 17 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 7 Number of Sites: 60 RELEASE ACTIVITY:USE1: 

PDM1 

SIC-CODE DESCRIPTION: 

SIC-CODE (S) EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 250. 0.008 8.00E-04 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 125.56 44.02 26.80 22.53 6.37E-03 1.82E-02 2.99E-02 3.55E-02

ALL 10 11.11 1.94 1.06 0.96 7.20E-02 0.41 0.75 0.83 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 3.40E-08 3.85E-07 mg/kg/day 4.61E-10 5.21E-09 mg/kg/day 

LADCpot 1.75E-06 1.97E-05 mg/L 5.52E-06 6.23E-05 mg/kg 

Acute 

ADRpot 1.52E-06 3.45E-05 mg/kg/day 3.62E-08 4.09E-07 mg/kg/day 

EPA SANITIZED Page 35 of 101
7/27/10 Page 18 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 7 RELEASE ACTIVITY: USE1: PDM1 

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES: 

SIC CODE RESULTS 

COC (μg/L) 

Percent of 

Year COC 

Exceeded 

Number of 

Days COC 

Exceeded 

Release 

days/year 

Loading 

(kg/site/day) 

Waste Water 

Treatment (%) 

High/Avg 

Analysis 

129.00 0 0 250.00 8.00E-03 90.00 High 

EPA SANITIZED Page 36 of 101
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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:8 Number of Release Sites: 60. 

 Release Activity: USE1: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 120.00 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 1.00 0.00/0.00 N/A N/A 

Per Site Release: 2.00 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 37 of 101
7/27/10 Page 20 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 8 Number of Sites: 60 RELEASE ACTIVITY:USE1: 

Max LADD 

SIC-CODE DESCRIPTION: 

SIC-CODE (S) EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 1. 2. 0.20 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 125.56 44.02 26.80 22.53 N/A N/A N/A N/A 

ALL 10 11.11 1.94 1.06 0.96 N/A N/A N/A N/A 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 3.40E-08 3.85E-07 mg/kg/day 4.61E-10 5.21E-09 mg/kg/day 

LADCpot 1.75E-06 1.97E-05 mg/L 5.52E-06 6.23E-05 mg/kg 

Acute 

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day 

EPA SANITIZED Page 38 of 101
7/27/10 Page 21 of 33 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 

ENVIRONMENTAL RELEASES 

 Scenario#:9 Number of Release Sites: 19. 

 Release Activity: USE2: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 245.97 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 248.00 0.00/0.00 N/A N/A 

Per Site Release: 5.22E-02 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 39 of 101
7/27/10 Page 22 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 9 Number of Sites: 19 RELEASE ACTIVITY:USE2: 

Max ADR 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 248. 0.0522 5.22E-03 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 281.14 130.69 82.66 67.99 1.86E-02 3.99E-02 6.32E-02 7.68E-02

ALL 10 13.93 8.70 5.00 4.20 0.37 0.60 1.04 1.24 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 9.84E-08 1.99E-06 mg/kg/day 1.33E-09 2.69E-08 mg/kg/day 

LADCpot 5.05E-06 1.02E-04 mg/L 1.59E-05 3.22E-04 mg/kg 

Acute 

ADRpot 3.34E-06 5.01E-05 mg/kg/day 1.05E-07 2.13E-06 mg/kg/day 

EPA SANITIZED Page 40 of 101
7/27/10 Page 23 of 33 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:10 Number of Release Sites: 19. 

 Release Activity: USE2: PDM1 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 245.97 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 248.00 0.00/0.00 N/A N/A 

Per Site Release: 5.22E-02 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 41 of 101
7/27/10 Page 24 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 10 Number of Sites: 19 RELEASE ACTIVITY:USE2: 

PDM1 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 248. 0.0522 5.22E-03 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 281.14 130.69 82.66 67.99 1.86E-02 3.99E-02 6.32E-02 7.68E-02

ALL 10 13.93 8.70 5.00 4.20 0.37 0.60 1.04 1.24 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 9.84E-08 1.99E-06 mg/kg/day 1.33E-09 2.69E-08 mg/kg/day 

LADCpot 5.05E-06 1.02E-04 mg/L 1.59E-05 3.22E-04 mg/kg 

Acute 

ADRpot 3.34E-06 5.01E-05 mg/kg/day 1.05E-07 2.13E-06 mg/kg/day 

EPA SANITIZED Page 42 of 101
7/27/10 Page 25 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 10 RELEASE ACTIVITY: USE2: PDM1 

SIC CODE DESCRIPTION: 

ASSOCIATED SIC CODES: 

SIC CODE RESULTS 

COC (μg/L) 

Percent of 

Year COC 

Exceeded 

Number of 

Days COC 

Exceeded 

Release 

days/year 

Loading 

(kg/site/day) 

Waste Water 

Treatment (%) 

High/Avg 

Analysis 

129.00 0 0 248.00 5.22E-02 90.00 High 

EPA SANITIZED Page 43 of 101
7/27/10 Page 26 of 33 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-10-0358 Assessor: 

ENVIRONMENTAL RELEASES 

 Scenario#:11 Number of Release Sites: 19. 

 Release Activity: USE2: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 245.97 N/A N/A N/A 

 (kg/yr) (kg/yr) (kg/yr) (kg/yr) 

 

 Non-sludge/Sludge 

Release Days/yr: 1.00 0.00/0.00 N/A N/A 

Per Site Release: 12.95 N/A/0.00 N/A N/A 

 (kg/site/day) (kg/site/day) (kg/site/day) (kg/site/day) 

Remarks: 

EPA SANITIZED Page 44 of 101
7/27/10 Page 27 of 33 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-10-0358 

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

SCENARIO #: 11 Number of Sites: 19 RELEASE ACTIVITY:USE2: 

Max LADD 

SIC-CODE DESCRIPTION: 

SIC-CODE (S): EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

90.00 1. 12.94 1.29 0.00 3.16 

AQUATIC EXPOSURE ESTIMATES - SURFACE WATER 

PLANT 

TYPE 

% ILE 

FACILITY 

STREAM FLOW (MLD) STREAM CONC. (μg/l) 

Harmonic 

Mean 30Q5 7Q10 1Q10 

Harmonic 

Mean 30Q5 7Q10 1Q10 

ALL 50 281.14 130.69 82.66 67.99 N/A N/A N/A N/A 

ALL 10 13.93 8.70 5.00 4.20 N/A N/A N/A N/A 

DRINKING WATER AND FISH INGESTION EXPOSURE ESTIMATES 

Exposure Units 

Drinking Water Results Drinking 

Water Units Fish Ingestion Results 

Fish 

Ingestion 

Units 

50% 10% 50% 10% 

Cancer 

LADDpot 9.84E-08 1.99E-06 mg/kg/day 1.33E-09 2.69E-08 mg/kg/day 

LADCpot 5.05E-06 1.02E-04 mg/L 1.59E-05 3.22E-04 mg/kg 

Acute 

ADRpot N/A N/A mg/kg/day N/A N/A mg/kg/day 

EPA SANITIZED Page 45 of 101
7/27/10 Page 28 of 33 

CEM Inputs ID Number: P-10-0358,12 

Product: unknown Chemical Name: P-10-0358 

Scenario Population: Adult 

Molecular Weight (g/mole): 660 Vapor Pressure (torr): 1e-06 

Consumer Product Weight Fraction - 

Central Tendency (unitless): 

0.0001 Consumer Product Weight Fraction - 

High-End (unitless): 

0.0001 

Inhalation Inputs 

Frequency of Use (chronic) (events/yr): 6 Exposure Duration (chronic) (years): 11 

Frequency of Use (acute) (events/day): 1 Exposure Duration (acute) (days): 1 

Mass of Product Used per Event - Central 

Tendency (g): 

227 Mass of Product Used per Event - 

High-End (g): 

738 

Inhalation Rate During Use (m3/hr): 1.1 Duration of Event - Central Tendency 

(hours/event): 

0.333 

Inhalation Rate After Use (m3/hr): 0.55 Duration of Event - High-End 

(hours/event): 

1 

Zone 1 Volume (m3): 20 Whole House Volume (m3): 369 

Air Exchange Rate (air exchanges/hr): 0.45 Body Weight (kg): 71.8 

Portion of Aerosol in Air (unitless): 0.01 

Activity Patterns 

User: 1 1 1 1 1 1 1 2 3 5 5 4 2 4 6 7 4 2 2 7 4 4 4 1 

Non-User: 1 1 1 1 1 1 1 1 3 2 4 4 2 4 7 7 4 2 2 7 4 4 4 1 

Hour:0 6 12 18 

Start Time: 9 Room of Use: 5. Utility Room 

Dermal Inputs 

There are no Dermal inputs for this scenario. 

Averaging Time (chronic) (days): 2.74e+04 Averaging time (acute) (days) : 1 

 

EPA SANITIZED Page 46 of 101
7/27/10 Page 29 of 33 

CEM Inhalation Exposure Estimates 

 ID Number: P-10-0358,12 

 Scenario: Population: Adult 

 Exposure Duration (years) chronic: 11 Exposure Duration (days) acute: 1 

 

Exposure Units Result AT (days) 

 Chronic Cancer 

 LADDpot (mg/kg-day) 1.60e-07 2.74e+04 

 LADCpot (mg/m3) 6.06e-07 2.74e+04 

 Acute 

 ADRpot (mg/kg-day) 1.39e-04 1 

 Cppot (mg/m3) 8.87e-03 NA 

 LADD - Lifetime Average Daily Dose(mg/kg-day) LADC - Lifetime Average Daily Concentration (mg/m3) 

 ADR - Acute Dose Rate (mg/kg-day) Cp - Peak Concentration (mg/m3) 

 

Note: 75 years = 2.738e+04 days pot - potential dose 

Note: The general Agency guidance for assessing short-term, infrequent events (for most chemicals, an exposure of less than 24 

hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than 

as chronic exposure. (Methods for Exposure-Response Analysis for Acute Inhalation Exposure to Chemicals (External 

Review Draft). EPA/600/R-98/051. April 1998 

EPA SANITIZED Page 47 of 101
7/27/10 Page 30 of 33 

CEM Inputs ID Number: P-10-0358,13 

Product: unknown Chemical Name: P-10-0358 

Scenario: Population: Adult 

Molecular Weight (g/mole): 660 Vapor Pressure (torr) 1e-06 

Consumer Product Weight Fraction - 

Central Tendency (unitless): 

0.0001 Consumer Product Weight Fraction - HighEnd (unitless): 0.0001 

Inhalation Inputs 

Frequency of Use (chronic) (events/yr): 4 Exposure Duration (chronic) (years): 11 

Frequency of Use (acute) (events/day): 1 Exposure Duration (acute) (days): 1 

Mass of Product Used per Event - Central 

Tendency (g): 

3635 Mass of Product Used per Event - High-End 

(g): 

1.272e+04

Inhalation Rate During Use (m3/hr): 1.1 Duration of Event - Central Tendency 

(hours/event): 

3 

Inhalation Rate After Use (m3/hr): 0.55 Duration of Event - High-End 

(hours/event): 

8 

Zone 1 Volume (m3): 40 Whole House Volume (m3): 369 

Air Exchange Rate (air exchanges/hr): 0.45 Body Weight (kg): 71.8 

 

Activity Patterns (Note: 1=Bedroom 2= Kitchen 3=Bathroom 4=Living Room 

 5=Utility Room 6=Car 7=Out) 

User: 1 1 1 1 1 1 1 2 3 1 1 1 1 1 1 1 1 1 2 7 4 4 4 1 

Non-User: 1 1 1 1 1 1 1 1 3 2 4 4 2 4 7 7 4 2 2 7 4 4 4 1 

Hour: 0 6 12 18 

Start Time: 10 Room of Use: 1. Bedroom 

Dermal Inputs 

Frequency of Use (chronic) (events/yr): 4 SA/BW (cm2/kg): 4.5 

Frequency of Use (acute) (events/day): 1 

 Exposure Duration (chronic) (years): 11 

Amount Retained / Absorbed to Skin 

(g/cm2-event): 

0.0114 Exposure Duration (acute) (days): 1 

 

 

 

EPA SANITIZED Page 48 of 101
7/27/10 Page 31 of 33 

Averaging Time (chronic) (days): 2.74e+04 Averaging Time (acute) (days) : 1 

 

 

EPA SANITIZED Page 49 of 101
7/27/10 Page 32 of 33 

CEM Inhalation Exposure Estimates 

 ID Number: P-10-0358,13 

 Scenario: Population: Adult 

 Exposure Duration (years) chronic: 11 Exposure Duration (days) acute: 1 

 

Exposure Units Result AT (days) 

 Chronic Cancer 

 LADDpot (mg/kg-day) 1.25e-06 2.74e+04 

 LADCpot (mg/m3) 6.82e-06 2.74e+04 

 Acute 

 ADRpot (mg/kg-day) 4.98e-05 1 

 Cppot (mg/m3) 2.73e-04 NA 

 LADD - Lifetime Average Daily Dose (mg/kg-day) LADC - Lifetime Average Daily Concentration (mg/m3) 

 ADR - Acute Dose Rate (mg/kg-day) Cp - Peak Concentration (mg/m3) 

 

Note: 75 years = 2.738e+04 days pot - potential dose 

Note: The general Agency guidance for assessing short-term, infrequent events (for most chemicals, an exposure of less than 24 

hours that occurs no more frequently than monthly) is to treat such events as independent, acute exposures rather than 

as chronic exposure. (Methods for Exposure-Response Analysis for Acute Inhalation Exposure to Chemicals (External 

Review Draft). EPA/600/R-98/051. April 1998)

EPA SANITIZED Page 50 of 101
7/27/10 Page 33 of 33 

CEM Dermal Exposure Estimates 

 ID Number: P-10-0358,13 

 Scenario: Population: Adult 

 Exposure Duration (chronic) (years): 11 Exposure Duration (acute) (days): 1 

 

Exposure Units Result AT (days) 

Chronic Cancer 

 LADDpot (mg/kg-day) 8.25e-06 2.74e+04 

Acute 

 ADRpot (mg/kg-day) 5.13e-03 1 

 LADD - Lifetime Average Daily Dose (mg/kg-day) 

 ADR - Acute Dose Rate (mg/kg-day) 

 

EPA SANITIZED Page 51 of 101
A-004 

TSCA Section 5(e) Consent Order 

 and Determinations Supporting Consent Order 

 for PMN P-10-358 

EPA SANITIZED Page 52 of 101
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

 In the matter of: ) Premanufacture Notice Number: 

 ) 

 ) 

 ) 

 ) 

 ) 

 ) P-10-358 

 ) 

 ) 

 ) 

 ) 

 ) 

_________________________________________________________________ 

Consent Order and Determinations Supporting Consent Order 

_________________________________________________________________ 

EPA SANITIZED Page 53 of 101
ii 

TABLE OF CONTENTS 

Preamble

I Introduction 

II. Summary of Terms of the Order 

III. Contents of PMN 

IV. EPA’s Assessment of Risk 

V. EPA’s Conclusions of Law 

VI. Information Required to Evaluate Human Health Effects 

Consent Order

I Scope of Applicability and Exemptions 

II. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal 

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Statistical Analysis of NCELs Analytical Method Verification Results 

Attachment C - Notice of Transfer of Consent Order 

EPA SANITIZED Page 54 of 101
iii 

PREAMBLE

I. INTRODUCTION

Under the authority of § 5(e) of the Toxic Substances Control Act (“TSCA”) (15 U.S.C. 

2604(e)), the Environmental Protection Agency (“EPA” or “the Agency”) issues the attached 

Order, regarding premanufacture notice (“PMN”) P-10-358 for the chemical substance 

 (“the PMN substance”) submitted by [

 (“the Company”), to take effect upon expiration of the PMN review period. The 

Company submitted the PMN to EPA pursuant to § 5(a)(1) of TSCA and 40 CFR Part 720. 

Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any 

provision of § 5 or any order issued under § 5. Violators may be subject to various penalties and 

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of 

TSCA, such as this one, are subject to the § 12(b) export notice requirement. 

II. SUMMARY OF TERMS OF THE ORDER

The Consent Order for this PMN substance requires the Company to: 

(1) provide its workers personal protective equipment to prevent dermal exposure; 

(2) use as described in the PMN; 

(3) comply with labeling, MSDS, and worker training in accordance with the provisions of the 

Hazard Communication Program section; 

(4) distribute the PMN substance only to a person who agrees to follow the same restrictions in 

EPA SANITIZED Page 55 of 101
iv 

the Order (except the testing requirements) or until it has been completely reacted; 

(5) an annual production volume of no more than [ ] kg; 

(6) not use as a powder or solid and; 

(7) maintain relevant records. 

EPA SANITIZED Page 56 of 101
v 

III. CONTENTS OF PMN

By signing this Order, the Company represents that it has carefully reviewed this document and 

agrees that all information herein that is claimed as confidential by the Company is correctly 

identified within brackets and that any information that is not bracketed is not claimed as 

confidential. To make this document available for public viewing, EPA will remove only the 

information contained within the brackets. 

Confidential Business Information Claims (Bracketed in the Preamble and Order): Company 

name, chemical identity, production volume, manufacturing, processing and use information 

Chemical Identity:

Specific: 

] 

Generic: Polycylic polyamine diester organometallic compound 

Use: 

Specific: [

Generic: Coatings additive at a 1 % concentration or less 

Maximum 12-Month Production Volume: [ ] 

Test Data Submitted with PMN: Physical /chemical properties, environmental fate, 

environmental effects and health effects. 

IV. EPA’S ASSESSMENT OF RISK

The following are EPA’s predictions regarding the probable human toxicity, human 

exposure of the PMN substance, based on the information currently available to the Agency. 

EPA SANITIZED Page 57 of 101
vi 

Human Health Effects Summary:

Absorption: Skin: 0%; Lung: 100%; GI Tract: 100% 

Toxicological Endpoints of Concern: Systemic Toxicity, neurotoxicity, dermal sensitization, 

acute toxicity and immunotoxicity. 

Basis: Based on submitted test data on the PMN substance. 

Environmental Effects Summary: There were no exceedences of the concern concentration 

COC of 129 parts per billion (ppb). 

Exposure and Environmental Release Summary:

Repackaging Processing Use 1 

 

Use 2 

# Sites [ ] [ ] [ ] [ 

Workers 

(#/site) 

[ ] [ ] [ ] 

Exposure 

(days/year) 

16 52 250 248 

Dermal Exposure 

(mg/day) 

18 18 .18 .18 

Inhalation Exposure 

(mg/day) 

Negligible Negligible .015 

(Particulate) 

.0092 (Mist) 

Risk to Workers: Based on engineering estimates and reviewed toxicity data, the subject PMN 

presents little risk of non-cancer injury to unprotected workers from inhalation exposures, 

because these exposures are very low. Dermal exposures are addressed through use of protective 

gloves and clothing. The PMN substance can present risks for acute toxicity, systemic toxicity, 

neurotoxicity, immunotoxicity and dermal sensitization. The impact of these concerns is 

mitigated by the low exposures to workers and the general population. One possible 

complication is if the production volume increases dramatically after the third year estimate of 

EPA SANITIZED Page 58 of 101
vii 

3000 kg, because the hazard potential of P-10-0358 appears substantive. The systemic NOAEL 

of 5 mg/kg can be associated with a modest acute toxicity LD50 of some 200 mg/kg, which, 

based on test animal deaths, could be lower. Also, immunotoxicity and mutagenicity concerns 

for the PMN substance have yet to be clarified. 

V. EPA’S CONCLUSIONS OF LAW

The following findings constitute the basis of the Consent Order: 

(a) EPA is unable to determine the potential for human health effects from exposure to the PMN 

substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information 

available to the Agency is insufficient to permit a reasoned evaluation of the human health 

effects of the PMN substance. 

(b) In light of the potential risk of the human health effects posed by the uncontrolled 

manufacture, import, processing, distribution in commerce, use, and disposal of the PMN 

substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled 

manufacture, import, processing, distribution in commerce, use, and disposal of the PMN 

substance may present an unreasonable risk of injury to human health. 

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS

Pended Testing. The following additional information would be required to evaluate the 

following effects which may be caused by the PMN substance: 

EPA SANITIZED Page 59 of 101
viii 

Information Guidelines

Acute Oral Toxicity in Rabbits OPPTS 870.1100 

The Order does not require submission of the above pended testing at any specified time or 

production volume. However, the Order’s restrictions on manufacture, import, processing, 

distribution in commerce, use, and disposal of the PMN substance will remain in effect until the 

Order is modified or revoked by EPA based on submission of that or other relevant information. 

EPA SANITIZED Page 60 of 101
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

(a) Scope. The requirements of this Order apply to all commercial manufacturing, processing, 

distribution in commerce, use and disposal of the chemical substance 

(P-l 0-358)("the PMN substance") in the United States by [ 

("the Company"), except to the extent that those activities are exempted by 

paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe 

PMN substance is exempt from the requirements of this Order (except the requirements in the 

. Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

extent that (1) these activities are conducted in full compliance with all applicable requirements 

. Internet Address (URL) • http://www.epa.gov 

RecycledfRecycJabJe • Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 

EPA SANITIZED Page 61 of 101
of the following exemptions, and (2) such compliance is documented by appropriate 

recordkeeping as required in the Recordkeeping section of this Order. 

(1) Completely Reacted (Cured). The requirements of this Order do not apply to quantities 

of the PMN substance after they have been completely reacted (cured). 

(2) De Minimis Concentrations. The requirements of this Order do not apply to quantities 

of the PMN substance that are (1) present in the work area only as a mixture and (2) at a 

concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or volume if 

the PMN substance is identified as a potential carcinogen in paragraph (f) of the Hazard 

Communication Program section of this Order). This exemption is not available if the Company 

has reason to believe that, during intended activities, the PMN substance in the mixture may be 

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. If this Order contains New 

Chemical Exposure Limits provisions or Release to Water provisions that, respectively, specify a 

NCEL concentration (“TWA”) or in-stream concentration (“N”) less than the de minimis 

concentration specified here, then this de minimis exemption does not apply to those provisions. 

 (3) Export. Until the Company begins commercial manufacture of the PMN substance for 

use in the United States, the requirements of this Order do not apply to manufacture, processing or 

distribution in commerce of the PMN substance solely for export in accordance with TSCA §12(a) 

and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to 

manufacture the PMN substance for use in the United States, no further activity by the Company 

involving the PMN substance is exempt as “solely for export” even if some amount of the PMN 

substance is later exported. At that point, the requirements of this Order apply to all activities 

EPA SANITIZED Page 62 of 101
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associated with the PMN substance while in the territory of the United States. Prior to leaving 

U.S. territory, even those quantities or batches of the PMN substance that are destined for export 

are subject to terms of the Order, and count towards any production volume test triggers in the 

Testing section of this Order. 

(4) Research & Development (“R&D”). The requirements of this Order do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in 

small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 

720.3(cc), and 40 CFR 720.36. The requirements of this Order also do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance when 

manufactured solely for non-commercial research and development per 40 CFR 720.30(i) and 

TSCA §5(i). 

(5) Byproducts. The requirements of this Order do not apply to the PMN substance when 

it is produced, without separate commercial intent, only as a “byproduct” as defined at 40 CFR 

720.3(d) and in compliance with 40 CFR 720.30(g). 

(6) No Separate Commercial Purpose. The requirements of this Order do not apply to the 

PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR 720.30(h), 

with no commercial purpose separate from the substance, mixture, or article of which it is a part. 

(7) Imported Articles. The requirements of this Order do not apply to the PMN substance 

when it is imported as part of an “article” as defined at 40 CFR 720.3(c) and in compliance with 40 

CFR 720.22(b)(1). 

(c) Automatic Sunset. If the Company has obtained for the PMN substance a Test Market 

EPA SANITIZED Page 63 of 101
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Exemption (“TME”) under TSCA §5(h)(1) and 40 CFR 720.38 or a Low Volume Exemption 

(“LVE”) or Low Release and Exposure Exemption (“LoREX”) under TSCA §5(h)(4) and 40 CFR 

723.50(c)(1) and (2) respectively, any such exemption is automatically rendered null and void as 

of the effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL

PENDING SUBMISSION AND EVALUATION OF INFORMATION

PROHIBITION

The Company is prohibited from manufacturing, importing, processing, distributing in 

commerce, using, or disposing of the PMN substance in the United States, for any nonexempt 

commercial purpose, pending the development of information necessary for a reasoned evaluation 

of the human health of the substance, and the completion of EPA’s review of, and regulatory 

action based on, that information, except in accordance with the conditions described in this Order. 

TESTING

(a) Section 8(e) Reporting. Reports of information on the PMN substance which reasonably 

supports the conclusion that the PMN substance presents a substantial risk of injury to health or the 

environment and which is required to be reported under TSCA section 8(e) shall reference the 

appropriate PMN identification number for this substance and contain a statement that the 

substance is subject to this Consent Order. Additional information regarding section 8(e) reporting 

requirements can be found at www.epa.gov/oppt/tsca8e. 

EPA SANITIZED Page 64 of 101
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(b) Notice of Study Scheduling. The Company shall notify, in writing, the EPA Laboratory Data 

Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. Environmental 

Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the following 

information within 10 days of scheduling any study required to be performed pursuant to this 

Order, or within 15 days after the effective date of this Order, whichever is later: 

(1) The date when the study is scheduled to commence; 

(2) The name and address of the laboratory which will conduct the study; 

(3) The name and telephone number of a person at the Company or the laboratory whom 

EPA may contact regarding the study; and, 

(4) The appropriate PMN identification number for each substance and a statement that the 

substance is subject to this Consent Order. 

(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be performed 

pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards 

at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific 

community at the time the study is initiated. Before starting to conduct any such study, the 

Company must obtain approval of test protocols from EPA by submitting written protocols. EPA 

will respond to the Company within 4 weeks of receiving the written protocols. Published test 

guidelines specified in paragraph (d) provide general guidance for development of test protocols, 

but are not themselves acceptable protocols. Approval of the test protocol does not mean preacceptance of test results. 

EPA SANITIZED Page 65 of 101
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(d) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in 

a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of each 

study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential business 

information is involved), the final report of each study and all underlying data (“the report and 

data”) to EPA no later than 14 weeks prior to exceeding the applicable production limit. The final 

report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted 

to EPA in accordance with the applicable “Reporting,” “Data and Reporting,” and “Test Report” 

subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the 

word “should” in those subparagraphs shall be interpreted to mean “shall” to make clear that the 

submission of such information is mandatory. EPA will not require the submission of raw data 

such as slides and laboratory notebooks unless if EPA finds, on the basis of professional judgment, 

that an adequate evaluation of the study cannot take place in the absence of these items. 

(e) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) 

of this Testing section if notified in writing by EPA that it is unnecessary to conduct that study. 

(f) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, 

the Company may continue to manufacture and import the PMN substance beyond the applicable 

production limit. To seek relief from any other restrictions of this Order, the Company may make 

a second attempt to obtain unequivocal data by reconducting the study under the conditions 

specified in paragraphs (b), (c), and (e)(1) and (2). The testing requirements may be modified, as 

EPA SANITIZED Page 66 of 101
- 7 - 

necessary to permit a reasoned evaluation of the risks presented by the PMN substance, only by 

mutual consent of EPA and the Company. 

(g) EPA Determination of Invalid Data.

(1) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA’s receipt of a 

test report and data, the Company receives written notice that EPA finds that the data generated by 

a study are scientifically invalid, the Company is prohibited from further manufacture and import 

of the PMN substance beyond the applicable production limit. 

(2) The Company may continue to manufacture and import the PMN substance beyond the 

applicable production limit only if so notified, in writing, by EPA in response to the Company’s 

compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). 

(i) The Company may reconduct the study in compliance with paragraphs (b), (c), 

and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report and data 

to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), 

the Company shall comply with subparagraph (e)(3). If there is insufficient time for the Company 

to comply with subparagraph (e)(3), the Company may exceed the production limit and shall 

submit the report and data in triplicate to EPA within a reasonable period of time, all as specified 

by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in 

writing, within 6 weeks of receiving the Company’s report and data. 

(ii) The Company may, within 4 weeks of receiving from EPA the notice described 

in subparagraph (h)(1), submit to EPA a written report refuting EPA’s finding. EPA will respond 

to the Company, in writing, within 4 weeks of receiving the Company’s report. 

EPA SANITIZED Page 67 of 101
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(h) Company Determination of Invalid Data.

(1) Except as described in subparagraph (i)(2), if the Company becomes aware that 

circumstances clearly beyond the control of the Company or laboratory will prevent, or have 

prevented, development of scientifically valid data under the conditions specified in paragraphs (c) 

and (e), the Company remains prohibited from further manufacture and import of the PMN 

substance beyond the applicable production limit. 

(2) The Company may submit to EPA, within 2 weeks of first becoming aware of such 

circumstances, a written statement explaining why circumstances clearly beyond the control of the 

Company or laboratory will cause or have caused development of scientifically invalid data. EPA 

will notify the Company of its response, in writing, within 4 weeks of receiving the Company’s 

report. EPA’s written response may either: 

(i) allow the Company to continue to manufacture and import the PMN substance 

beyond the applicable production limit, or 

(ii) require the Company to continue to conduct, or to reconduct, the study in 

compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to conduct or 

reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the 

production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph 

(e)(3). If there is insufficient time for the Company to comply with subparagraph (e)(3), the 

Company may exceed the production limit and shall submit the report and data in triplicate to EPA 

within a reasonable period of time, all as specified by EPA in the notice described in subparagraph 

(i)(2). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company’s 

EPA SANITIZED Page 68 of 101
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report and data, as to whether the Company may continue to manufacture and import beyond the 

applicable production limit. 

(i) Unreasonable Risk.

(1) EPA may notify the Company in writing that EPA finds that the data generated by a 

study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the 

PMN substance will or may present an unreasonable risk of injury to human health or the 

environment. EPA’s notice may specify that the Company undertake certain actions concerning 

further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN 

substance to mitigate exposures to or to better characterize the risks presented by the PMN 

substance. Within 2 weeks from receipt of such a notice, the Company must cease all 

manufacture, import, processing, distribution, use and disposal of the PMN substance, unless 

either: 

(2) within 2 weeks from receipt of the notice described in subparagraph (j)(1), the 

Company complies with such requirements as EPA’s notice specifies; or 

(3) within 4 weeks from receipt of the notice described in subparagraph (j)(1), the 

Company submits to EPA a written report refuting EPA’s finding and/or the appropriateness of 

any additional requirements imposed by EPA. The Company may continue to manufacture, 

import, process, distribute, use and dispose of the PMN substance in accordance with the terms of 

this Order pending EPA’s response to the Company’s written report. EPA will respond to the 

Company, in writing, within 4 weeks of receiving the Company’s report. Within 2 weeks of 

receipt of EPA’s written response, the Company shall comply with any requirements imposed by 

EPA SANITIZED Page 69 of 101
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EPA’s response or cease all manufacture, import, processing, distribution, use and disposal of the 

PMN substance. 

(j) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing 

section, the Company must continue to obey all the terms of this Consent Order until otherwise 

notified in writing by EPA. The Company may, based upon submitted test data or other relevant 

information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part 

VI. of this Consent Order. 

PROTECTION IN THE WORKPLACE

(a) Establishment of Program. During manufacturing, processing, and use of the PMN substance 

at any site controlled by the Company (including any associated packaging and storage and during 

any cleaning or maintenance of equipment associated with the PMN substance), the Company 

must establish a program whereby: 

 (1) General Dermal Protection. Each person who is reasonably likely to be dermally 

exposed in the work area to the PMN substance through direct handling of the substance or 

through contact with equipment on which the substance may exist, or because the substance 

becomes airborne in a form listed in subparagraph (a)(5) of this section, is provided with, and is 

required to wear, personal protective equipment that provides a barrier to prevent dermal exposure 

to the substance in the specific work area where it is selected for use. Each such item of personal 

protective equipment must be selected and used in accordance with Occupational Safety and 

Health Administration (“OSHA”) dermal protection requirements at 29 CFR 1910.132, 1910.133, 

EPA SANITIZED Page 70 of 101
- 11 - 

and 1910.138. 

 (2) Specific Dermal Protective Equipment. The dermal personal protective equipment 

required by subparagraph (a)(1) of this section must include, but is not limited to, the following 

items: 

(i) Gloves. 

(ii) Full body chemical protective clothing. 

 (iii) Chemical goggles or equivalent eye protection. 

(iv) Clothing which covers any other exposed areas of the arms, legs and torso.

 (3) Demonstration of Imperviousness. The Company is able to demonstrate that each item 

of chemical protective clothing selected, including gloves, provides an impervious barrier to 

prevent dermal exposure during normal and expected duration and conditions of exposure within 

the work area by any one or a combination of the following: 

 (i) Permeation Testing. Testing the material used to make the chemical protective 

clothing and the construction of the clothing to establish that the protective clothing will be 

impervious for the expected duration and conditions of exposure. The testing must subject the 

chemical protective clothing to the expected conditions of exposure, including the likely 

combinations of chemical substances to which the clothing may be exposed in the work area. 

Permeation testing shall be conducted according to the American Society for Testing and Materials 

(“ASTM”) F739 “Standard Test Method for Resistance of Protective Clothing materials to 

Permeation by Liquids or Gases.” Results shall be recorded as a cumulative permeation rate as a 

function of time, and shall be documented in accordance with ASTM F739 using the format 

specified in ASTM F1194-99 “Guide for Documenting the Results of Chemical Permeation 

EPA SANITIZED Page 71 of 101
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Testing on Protective Clothing Materials.” Gloves may not be used for a time period longer than 

they are actually tested and must be replaced at the end of each work shift during which they are 

exposed to the PMN substance. 

(ii) Manufacturer’s Specifications. Evaluating the specifications from the 

manufacturer or supplier of the chemical protective clothing, or of the material used in 

construction of the clothing, to establish that the chemical protective clothing will be impervious to 

the PMN substance alone and in likely combination with other chemical substances in the work 

area. 

 (5) Physical States. The following physical states of airborne chemical substances are 

listed for subparagraphs (a)(1) and (4) of this section: 

(i) Particulate (including solids or liquid droplets), 

(ii) Gas/vapor (all substances in the gas form), or 

(iii) Combination Gas/Vapor and Particulate (gas and liquid/solid physical states 

are both present; a good example is paint spray mist, which contains both liquid droplets and 

vapor). 

HAZARD COMMUNICATION PROGRAM

(a) Written Hazard Communication Program. The Company shall develop and implement a 

written hazard communication program for the PMN substance in each workplace. The written 

program will, at a minimum, describe how the requirements of this section for labels, MSDSs, and 

other forms of warning material will be satisfied. The Company must make the written hazard 

EPA SANITIZED Page 72 of 101
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communication program available, upon request, to all employees, contractor employees, and their 

designated representatives. The Company may rely on an existing hazard communication 

program, including an existing program established under the OSHA Hazard Communication 

Standard (29 CFR 1910.1200), to comply with this paragraph provided that the existing hazard 

communication program satisfies the requirements of this section. The written program shall 

include the following: 

(1) A list of chemical substances known to be present in the work area which are subject to 

a TSCA section 5(e) consent order signed by the Company or to a TSCA section 5(a)(2) SNUR at 

40 C.F.R. Part 721, subpart E. The list must be maintained in each work area where the PMN 

substance is known to be present and must use the identity provided on the MSDS for the 

substance required under paragraph (c) of this section. The list may be compiled for the workplace 

or for individual work areas. If the Company is required either by another Order issued under 

section 5(e) of TSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to 

maintain a list of substances, the lists shall be combined with the list under this subparagraph. 

(2) The methods the Company will use to inform employees of the hazards of non-routine 

tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the hazards associated 

with the PMN substance contained in unlabeled pipes in their work area. 

(3) The methods the Company will use to inform contractors of the presence of the PMN 

substance in the Company’s workplace and of the provisions of this Order if employees of the 

contractor work in the Company’s workplace and are reasonably likely to be exposed to the PMN 

substance while in the Company’s workplace. 

EPA SANITIZED Page 73 of 101
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(b) Labeling.

(1) The Company shall ensure that each container of the substance in the workplace is 

labeled in accordance with this subparagraph (b)(1). 

(i) The label shall, at a minimum, contain the following information: 

(I) A statement of the health hazards(s) and precautionary measure(s), if 

any, identified in paragraph (f) of this section or by the Company, for the PMN substance. 

(II) The identity by which the PMN substance may be commonly 

recognized. 

(III) A statement of the environmental hazard(s) and precautionary 

measure(s), if any, identified in paragraph (f) of this section, or by the Company, for the PMN 

substance. 

(IV) A statement of exposure and precautionary measure(s), if any, 

identified in paragraph (f) of this section, or by the Company, for the PMN substance. 

(ii) The Company may use signs, placards, process sheets, batch tickets, operating 

procedures, or other such written materials in lieu of affixing labels to individual stationary process 

containers, as long as the alternative method identifies the containers to which it is applicable and 

conveys information specified by subparagraph (b)(1)(i) of this section. Any written materials 

must be readily accessible to the employees in their work areas throughout each work shift. 

(iii) The Company need not label portable containers into which the PMN 

substance is transferred from labeled containers, and which are intended only for the immediate 

use of the employee who performs the transfer. 

(iv) The Company shall not remove or deface an existing label on containers of the 

EPA SANITIZED Page 74 of 101
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PMN substance obtained from persons outside the Company unless the container is immediately 

re-labeled with the information specified in subparagraph (b)(1)(i) of this section. 

(2) The Company shall ensure that each container of the substance leaving its workplace 

for distribution in commerce is labeled in accordance with this subparagraph (b)(2). 

(i) The label shall, at a minimum, contain the following information: 

(I) The information prescribed in subparagraph (b)(1)(i) of this section. 

(II) The name and address of the manufacturer or a responsible party who 

can provide additional information on the substance for hazard evaluation and any appropriate 

emergency procedures. 

(ii) The label shall not conflict with the requirements of the Hazardous Materials 

Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the 

Department of Transportation. 

(3) The label, or alternative forms of warning, shall be legible and prominently displayed. 

(4) The label, or alternative forms of warning, shall be printed in English; however, the 

information may be repeated in other languages. 

(5) If the label or alternative form of warning is to be applied to a mixture containing the 

PMN substance in combination with any other substance that is either subject to another TSCA 

section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 

CFR Part 721, subpart E, or defined as a “hazardous chemical” under the OSHA Hazard 

Communication Standard (29 CFR 1910.1200), the Company may prescribe on the label, MSDS, 

or alternative form of warning, the measures to control worker exposure or environmental release 

which the Company determines provide the greatest degree of protection. However, should these 

EPA SANITIZED Page 75 of 101
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control measures differ from the applicable measures required under this Order, the Company must 

seek a determination of equivalency for such alternative control measures pursuant to 40 CFR 

721.30 before prescribing them under this subparagraph (b)(5). 

(6) If the Company becomes aware of any significant new information regarding the 

hazards of the PMN substance or ways to protect against the hazards, this new information must be 

added to the label within 3 months from the time the Company becomes aware of the new 

information. If the PMN substance is not being manufactured, imported, processed, or used in the 

Company’s workplace, the Company must add the new information to the label before the PMN 

substance is reintroduced into the workplace. 

(c) Material Safety Data Sheets.

(1) The Company must obtain or develop an MSDS for the PMN substance. 

(2) The MSDS shall contain, at a minimum, the following information: 

(i) The identity used on the container label of the PMN substance under this 

section, and, if not claimed confidential, the chemical and common name of the PMN substance. 

If the chemical and common name is claimed confidential, a generic chemical name must be used. 

(ii) Physical and chemical characteristics of the substance known to the Company, 

(e.g., vapor pressure, flash point). 

(iii) The physical hazards of the substance known to the Company, including the 

potential for fire, explosion, and reactivity. 

(iv) The potential human and environmental hazards as specified in paragraph (f) 

of this section. 

EPA SANITIZED Page 76 of 101
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(v) Signs and symptoms of exposure, and any medical conditions which are 

expected to be aggravated by exposure to the PMN substance known to the Company. 

(vi) The primary routes of exposure to the PMN substance. 

(vii) Precautionary measures to control worker exposure and/or environmental 

release required by this Order, or alternative control measures which EPA has determined under 40 

CFR 721.30 provide substantially the same degree of protection as the identified control measures. 

The MSDS must identify any New Chemical Exposure Limits specified in paragraph (b) of the 

New Chemical Exposure Limit section of this Order and must contain the information specified in 

the graduated respirator table in paragraph (e)(2) of the New Chemical Exposure Limit section. 

(viii) Any generally applicable precautions for safe handling and use of the PMN 

substance which are known to the Company, including appropriate hygienic practices, protective 

measures during repair and maintenance of contaminated equipment, and procedures for response 

to spills and leaks. 

(ix) Any generally applicable control measures which are known to the Company, 

such as appropriate engineering controls, work practices, or personal protective equipment. 

(x) Emergency first aid procedures known to the Company. 

(xi) The date of preparation of the MSDS or of its last revision. 

(xii) The name, address, and telephone number of the Company or another 

responsible party who can provide additional information on the chemical substance and any 

appropriate emergency procedures. 

(3) If no relevant information is found or known for any given category on the MSDS, the 

Company must mark the MSDS to indicate that no applicable information was found. 

EPA SANITIZED Page 77 of 101
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(4) Where multiple mixtures containing the PMN substance have similar compositions 

(i.e., the chemical ingredients are essentially the same, but the specific composition varies from 

mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of 

these multiple mixtures. 

(5) If the Company becomes aware of any significant new information regarding the 

hazards of the PMN substance or ways to protect against the hazards, this new information must be 

added to the MSDS within 3 months from the time the Company becomes aware of the new 

information. If the PMN substance is not being manufactured, imported, processed, or used in the 

Company’s workplace, the Company must add the new information to the MSDS before the PMN 

substance is reintroduced into the workplace. 

(6) The Company must ensure that persons receiving the PMN substance from the 

Company are provided an appropriate MSDS with their initial shipment and with the first shipment 

after an MSDS is revised. The Company may either provide the MSDS with the shipped 

containers or send it to the person prior to or at the time of shipment. 

(7) The Company must maintain a copy of the MSDS in its workplace, and must ensure 

that it is readily accessible during each work shift to employees when they are in their work areas. 

(8) The MSDS may be kept in any form, including as operating procedures, and may be 

designed to cover groups of substances in a work area where it may be more appropriate to address 

the potential hazards of a process rather than individual substances. However, in all cases, the 

required information must be provided for the PMN substance and must be readily accessible 

during each work shift to employees when they are in their work areas. 

(9) The MSDS must be printed in English; however, the information may be repeated in 

EPA SANITIZED Page 78 of 101
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other languages. 

(d) Employee Information and Training. The Company must ensure that employees are provided 

with information and training on the PMN substance. This information and training must be 

provided at the time of each employee’s initial assignment to a work area containing the PMN 

substance and whenever the PMN substance is introduced into the employee’s work area for the 

first time. 

(1) The information provided to employees under this paragraph shall include: 

(i) The requirements of this section. 

(ii) Any operations in the work area where the PMN substance is present. 

(iii) The location and availability of the written hazard communication program 

required under paragraph (a) of this section, including the list of substances required by 

subparagraph (a)(1) of this section and MSDSs required by paragraph (c) of this section. 

(2) The training provided to employees shall include: 

(i) Methods and observations that may be used to detect the presence or release of 

the PMN substance in or from an employee’s work area (such as exposure monitoring conducted 

by the Company, continuous monitoring devices, visual appearance, or odor of the substance when 

being released). 

(ii) The potential human health and environmental hazards of the PMN substance 

as specified in paragraph (f) of this section. 

(iii) The measures employees can take to protect themselves and the environment 

from the PMN substance, including specific procedures the Company has implemented to protect 

EPA SANITIZED Page 79 of 101
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employees and the environment from exposure to the PMN substance, including appropriate work 

practices, emergency procedures, personal protective equipment, engineering controls, and other 

measures to control worker exposure and/or environmental release required under this Order, or 

alternative control measures which EPA has determined under 40 CFR 721.30 provide the same 

degree of protection as the specified control measures. 

(iv) The requirements of the hazard communication program developed by the 

Company under this section, including an explanation of the labeling system and the MSDS 

required by this section and guidance on obtaining and using appropriate hazard information. 

(e) Existing Hazard Communication Program. The Company need not take additional actions if 

existing programs and procedures satisfy the requirements of this section. 

(f) Human Health, Exposure, and Precautionary Statements. The following human health and 

environmental hazard and precautionary statements shall appear on each label as specified in 

paragraph (b) and the MSDS as specified in paragraph (c) of this section: 

(1) Human health hazard statements. This substance may cause: 

(i) skin irritation.

(ii) central nervous system effects. 

 (iii) internal organ effects. 

(iv) immune system effects. 

 (2) Human hazard precautionary statements. When using this substance: 

(i) avoid skin contact. 

EPA SANITIZED Page 80 of 101
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(ii) use skin protection. 

(3) Environmental hazard statements. This substance may be: 

(i) toxic to fish. 

(ii) toxic to aquatic organisms. 

 (4) The human healthl hazard and precautionary statement on the label prepared pursuant 

to paragraph (b) of this section must be followed by the statement: “See the MSDS for details.” 

MANUFACTURING

(a)(1) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or 

import of the PMN substance by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after promulgation 

of a final significant new use rule (“SNUR”) governing the PMN substance under section 5(a)(2) 

of TSCA unless the Company is notified on or before that day of an action in a Federal Court 

seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)(1) shall not 

expire until EPA notifies the Company in writing that all Federal Court actions involving the 

SNUR have been resolved and the validity of the SNUR affirmed. 

(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and 

subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify each 

person whom it causes, encourages or suggests to manufacture or import the PMN substance of the 

existence of the SNUR. 

(b) The Company shall not manufacture the PMN substance: 

EPA SANITIZED Page 81 of 101
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(1) Beyond an annual manufacture and importation volume of [ ; 

(2) In the form of a powder; or 

(3) In the form of a solid. 

PROCESSING

a) The Company shall not process the PMN substance: 

(1) In the form of a powder; or 

(2) In the form of a solid. 

USE

(a) The Company shall not use the PMN substance: 

(1) Other than as described in the PMN; 

(2) In the form of a powder; or 

(3) In the form of a solid. 

DISTRIBUTION

(a) Export Notice Requirement. No later than the date of distribution, the Company shall notify in 

writing any person to whom it distributes the PMN substance that, due to the issuance of this 

Consent Order under section 5(e) of TSCA, the PMN substance is subject to the export notification 

requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in 

the form in which it appears in this Consent Order, the following information: (1) the PMN 

number, and (2) either (A) the specific chemical identity of the PMN substance, or (B) if the 

specific chemical identity is confidential, the generic chemical identity. 

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(b) Distribution Requirements. (i) Except after the PMN substance has been completely reacted 

(or cured), or as provided in paragraph (c), the Company shall distribute the PMN substance 

outside the Company, other than for disposal, only to a person who has agreed in writing prior to 

the date of distribution, to follow the same restriction in the Consent Order (except for the testing 

requirements) and to : 

 (1) Notify in writing any person to whom it distributes the PMN substance that, due to the 

issuance of this Consent Order under section 5(e) of TSCA, the PMN substance is subject to the 

export notification requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D. Such 

notice shall contain, in the form in which it appears in this Consent Order, the following 

information: 

(1) the PMN number, and (2) either (A) the specific chemical identity of the PMN 

substance, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(2) Not further distribute the PMN substance to any other person, other than for disposal, 

unless that person has agreed in writing prior to the date of distribution to follw the same 

restrictions in the Order ( except for the testing requirements) or until after the PMN substance has 

been completely reacted (cured). 

 (3) Comply with the same requirements and restrictions, if any, required of the Company 

in the Hazard Communication Program section of this Order. 

 (4) Not process the PMN substance: 

(i) In the form of a powder; or 

(v) In the form of a solid. 

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 (5) Not use the PMN substance: 

(i) Other than as described in the PMN; 

(ii) In the form of a powder; or 

(iii) In the form of a solid.. 

(ii) Disposal Exemption. Except for the §12(b) export notice requirement in paragraph 

(b)(i)(1) above, the distribution requirements in (b)(i) do not apply when the Company distributes 

the PMN substance for disposal only. 

(c) Temporary Transport and Storage. Notwithstanding paragraph (b), the Company may 

distribute the PMN substance outside the Company for temporary transport and storage in sealed 

containers (labeled in accordance with paragraph (b)(2) of the Hazard Communication Program 

section of this Order) provided the following two conditions are met: 

(1) Subsequent to any such exempt temporary transport or storage of sealed containers, the 

PMN substance may be distributed only to the Company or a person who has given the Company 

the written agreement required by paragraph (b). 

(2) Any human exposure or environmental release resulting from opening the sealed 

containers and removing or washing out the PMN substance may occur only while the PMN 

substance is in the possession and control of the Company or a person who has given the Company 

the written agreement required by paragraph (b). 

(d) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of the 

PMN substance, the Company obtains knowledge that a recipient of the substance has failed to 

EPA SANITIZED Page 84 of 101
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comply with any of the conditions specified in paragraph (b) of this Distribution section or, after 

paragraph (b)(2) expires in accordance with subparagraph (e)(1), has engaged in a significant new 

use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a 

significant new use notice to EPA, the Company shall cease supplying the substance to that 

recipient, unless the Company is able to document each of the following: 

(1) That the Company has, within 5 working days, notified the recipient in writing that the 

recipient has failed to comply with any of the conditions specified in paragraph (b) of this 

Distribution section, or has engaged in a significant new use of the PMN substance without 

submitting a significant new use notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, the 

Company received from the recipient, in writing, a statement of assurance that the recipient is 

aware of the terms of paragraph (b) of this Distribution section and will comply with those terms, 

or is aware of the terms of the significant new use rule for the PMN substance and will not engage 

in a significant new use without submitting a significant new use notice to EPA. 

(3) If, after receiving a statement of assurance from a recipient under subparagraph (d)(2) 

of this Distribution section, the Company obtains knowledge that the recipient has failed to comply 

with any of the conditions specified in paragraph (b) of this Distribution section, or has engaged in 

a significant new use of the PMN substance without submitting a significant new use notice to 

EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of 

the failure to comply, and shall resume supplying the PMN substance to that recipient only upon 

written notification from the Agency. 

EPA SANITIZED Page 85 of 101
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(e) Sunset Following SNUR. (1) Paragraph (b)(2) of this Distribution section shall expire 75 

days after promulgation of a final SNUR for the PMN substance under section 5(a)(2) of TSCA, 

unless the Company is notified on or before that day of an action in a Federal Court seeking 

judicial review of the SNUR. If the Company is so notified, paragraph (b)(2) of this Distribution 

section shall not expire until EPA notifies the Company in writing that all Federal Court actions 

involving the SNUR have been resolved and the validity of the SNUR affirmed. 

(2) When EPA promulgates a final SNUR for the PMN substance and paragraph (b)(2) of this 

Distribution section expires in accordance with subparagraph (e)(1), the Company shall notify each 

person to whom it distributes the PMN substance of the existence of the SNUR. Such notification 

must be in writing and must specifically include all limitations contained in the SNUR which are 

defined as significant new uses, and which would invoke significant new use notification to EPA 

for the PMN substance. Such notice must also reference the publication of the SNUR for this 

PMN substance in either the Federal Register or the Code of Federal Regulations. After 

promulgation of a SNUR and expiration of subparagraph (b)(2), such notice may substitute for the 

written agreement required in the introductory clause of paragraph (b); so that, if the Company 

provides such notice to the persons to whom it distributes the PMN substance, then the Company 

is not required to obtain from such persons the written agreement specified in paragraph (b). 

III. RECORDKEEPING

(a) Records. The Company shall maintain the following records until 5 years after the date they 

are created and shall make them available for inspection and copying by EPA in accordance with 

EPA SANITIZED Page 86 of 101
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section 11 of TSCA: 

(1) Exemptions. Records documenting that the PMN substance did in fact qualify for any 

one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records 

must satisfy all the statutory and regulatory recordkeeping requirements applicable to the 

exemption being claimed by the Company. Any amounts or batches of the PMN substance 

eligible for the Export exemption in Section I, Paragraph (b)(3) of this Order are exempt from all 

the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance 

eligible for the Research and Development exemption in Section I, Paragraph (b)(4) of this Order, 

are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 

5 years from the date of their creation, the records required by 40 CFR 720.78(b). For any 

amounts or batches of the PMN substance claimed to be eligible for any other exemption described 

in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating 

qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, 

but is exempt from the other recordkeeping requirements in this Recordkeeping section; 

(2) Records documenting the manufacture and importation volume of the PMN substance 

and the corresponding dates of manufacture and import; 

(3) Records documenting the names and addresses (including shipment destination 

address, if different) of all persons outside the site of manufacture or import to whom the Company 

directly sells or transfers the PMN substance, the date of each sale or transfer, and the quantity of 

the substance sold or transferred on such date; 

EPA SANITIZED Page 87 of 101
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(4) Records documenting the address of all sites of manufacture, import, processing, and 

use; 

(5) Records documenting establishment and implementation of a program for the use of 

any applicable personal protective equipment required pursuant to the Protection in the Workplace 

section of this Order; 

(6) Records documenting the determinations required by the Protection in the Workplace 

section of this Order that chemical protective clothing is impervious to the PMN substance; 

 (7) Records documenting establishment and implementation of the hazard communication 

program required by the Hazard Communication Program section of this Order; 

(8) Copies of labels required under the Hazard Communication Program section of this 

Order; 

(9) Copies of Material Safety Data Sheets required by the Hazard Communication 

Program section of this Order; 

(10) Records documenting compliance with any applicable manufacturing, processing, 

use, and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections 

of this Order, including distributees’ written agreement to comply with the Distribution section of 

this Order; 

(11) Copies of any Transfer Documents and notices required by the Successor Liability 

section of this Order, if applicable; and 

(13) The Company shall keep a copy of this Order at each of its sites where the PMN 

substance is manufactured or imported. 

EPA SANITIZED Page 88 of 101
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(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities 

of the Company and its Contract Manufacturer, if applicable, and not to activities of the 

Company’s customers. 

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this “collection of 

information” unless this Order displays a currently valid control number from the Office of 

Management and Budget (“OMB”), and EPA so informs the Company. The “collection of 

information” required in this TSCA §5(e) Consent Order has been approved under currently valid 

OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA’s Request for Information. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA 

may occasionally conduct on-site compliance inspections of Company facilities and conveyances 

associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the 

Company in advance to request information pertinent to the scheduling and conduct of such 

inspections. Such requests may be written or oral. The types of information that EPA may request 

include, but are not limited to, the following: 

(i) Expected dates and times when the PMN substance will be in production within the 

subsequent 12 months; 

(ii) Current workshift schedules for workers who are involved in activities associated with 

the PMN substance and may reasonably be exposed to the PMN substance; 

EPA SANITIZED Page 89 of 101
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(iii) Current job titles or categories for workers who are involved in activities associated 

with the PMN substance and may reasonably be exposed to the PMN substance; 

(iv) Existing exposure monitoring data for workers who are involved in activities 

associated with the PMN substance and may reasonably be exposed to the PMN substance; 

(v) Records required by the Recordkeeping section of this Order; and/or 

(vi) Any other information reasonably related to determining compliance with this Order 

or conducting an inspection for that purpose. 

(b) Company’s Response. The Company shall respond to such requests within a reasonable 

period of time, but in no event later than 30 days after receiving EPA’s request. When requested 

in writing by EPA, the Company’s response shall be in writing. To the extent the information is 

known to or reasonably ascertainable to the Company at the time of the request, the Company’s 

response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers 

to all of EPA’s requests. 

(c) Confidential Business Information. Any Confidential Business Information (“CBI”) that the 

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with §14 of 

TSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER

(a) Scope. This section sets forth the procedures by which the Company’s rights and obligations 

under this Order may be transferred when the Company transfers its interests in the PMN 

EPA SANITIZED Page 90 of 101
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substance, including the right to manufacture the PMN substance, to another person outside the 

Company (the “Successor in Interest”). 

(b) Relation of Transfer Date to Notice of Commencement (“NOC”).

(1) Before NOC. If the transfer from the Company to the Successor in Interest is effective 

before EPA receives a notice of commencement of manufacture or import (“NOC”) for the PMN 

substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a 

new PMN to EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective 

after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and 

shall not be required to submit a new PMN to EPA. 

(c) Definitions. The following definitions apply to this Successor Liability section of the Order: 

(1) “Successor in Interest” means a person outside the Company who has acquired the 

Company’s full interest in the rights to manufacture the PMN substance, including all ownership 

rights and legal liabilities, through a transfer document signed by the Company, as transferor, and 

the Successor in Interest, as transferee. The term excludes persons who acquire less than the full 

interest of the Company in the PMN substance, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substance. A Successor in 

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CFR 720.22(a)(3). 

EPA SANITIZED Page 91 of 101
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(2) “Transfer Document” means the legal instrument(s) used to convey the interests in the 

PMN substance, including the right to manufacture the PMN substance, from the Company to the 

Successor in Interest. 

(d) Notices.

(1) Notice to Successor in Interest. On or before the effective date of the transfer, the 

Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent 

Order and the “Notice of Transfer” document which is incorporated by reference as Attachment C 

to this Order. 

(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the 

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: 

U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania 

Avenue, N.W., Washington, D.C. 20460. 

(3) Transfer Document. Copies of the Transfer Document must be maintained by the 

Successor in Interest at its principal place of business, and at all sites where the PMN substance is 

manufactured or imported. Copies of the Transfer Document must also be made available for 

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability for the PMN substance under the terms of this 

Order from the Company to the Successor in Interest. 

(e) Liability.

(1) The Company shall be liable for compliance with the requirements of this Order until 

EPA SANITIZED Page 92 of 101
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the effective date of the transfer described above. 

(2) The Successor in Interest shall be liable for compliance with the requirements of this 

Order effective as of the date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made, during the time in which the Company manufactured, processed, used, distributed 

in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order. 

(f) Obligations to Submit Test Data under Consent Order. If the Testing section of this Consent 

Order requires the Company to submit test data to EPA at a specified production volume (“test 

trigger”), the aggregate volume of the PMN substance manufactured and imported by the 

Company up to the date of transfer shall count towards the test trigger applicable to the Successor 

in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER

The Company may petition EPA at any time, based upon new information on the health 

effects of, or human exposure to, the PMN substance, to modify or revoke substantive provisions 

of this Order. The exposures and risks identified by EPA during its review of the PMN substance 

and the information EPA determined to be necessary to evaluate those exposures and risks are 

described in the preamble to this Order. However, in determining whether to amend or revoke this 

Order, EPA will consider all relevant information available at the time the Agency makes that 

determination, including, where appropriate, any reassessment of the test data or other information 

EPA SANITIZED Page 93 of 101
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that supports the findings in this Order, an examination of new test data or other information or 

analysis, and any other relevant information. 

EPA will issue a modification or revocation if EPA determines that the activities proposed 

therein will not present an unreasonable risk of injury to health or the environment and will not 

result in significant or substantial human exposure or substantial environmental release in the 

absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of 

the PMN substance. 

In addition, the Company may petition EPA at any time to make other modifications to the 

language of this Order. EPA will issue such a modification if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 

EPA SANITIZED Page 94 of 101
EPA SANITIZED

Page 95 of 101
ATTACHMENT A 

DEFINITIONS 

[Note: The attached Order may not contain some of the terms defined below.]

 “Chemical name” means the scientific designation of a chemical substance in accordance 

with the nomenclature system developed by the Chemical Abstracts Service’s rules of 

nomenclature, or a name which will clearly identify a chemical substance for the purpose of 

conducting a hazard evaluation. 

 “Chemical protective clothing” means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substances of concern. Examples can include, but are not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

 “Company” means the person or persons subject to this Order. 

 “Commercial use” means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting contractor). 

 “Common name” means any designation or identification such as code name, code number, 

trade name, brand name, or generic chemical name used to identify a chemical substance other 

than by its chemical name. 

 “Consumer” means a private individual who uses a chemical substance or any product 

containing the chemical substance in or around a permanent or temporary household or residence, 

during recreation, or for any personal use or enjoyment. 

 “Consumer product” means a chemical substance that is directly, or as part of a mixture, 

sold or made available to consumers for their use in or around a permanent or temporary 

household or residence, in or around a school, or in recreation. 

 “Container” means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. For purposes of this section, pipes or piping 

systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be 

containers. 

 “Contract Manufacturer” means a person, outside the Company, who is authorized to 

manufacture and import the PMN substance under the conditions specified in Part II. of this 

Consent Order and in the Consent Order for Contract Manufacturer. 

 “Identity” means any chemical or common name used to identify a chemical substance or a 

mixture containing that substance. 

EPA SANITIZED Page 96 of 101
 “Immediate use.” A chemical substance is for the “immediate use” of a person if it is under 

the control of, and used only by, the person who transferred it from a labeled container and will 

only be used by that person within the work shift in which it is transferred from the labeled 

container. 

 “Impervious.” Chemical protective clothing is “impervious” to a chemical substance if the 

substance causes no chemical or mechanical degradation, permeation, or penetration of the 

chemical protective clothing under the conditions of, and the duration of, exposure. 

 “Manufacturing stream” means all reasonably anticipated transfer, flow, or disposal of a 

chemical substance, regardless of physical state or concentration, through all intended operations 

of manufacture, including the cleaning of equipment. 

 “MSDS” means material safety data sheet, the written listing of data for the chemical 

substance.

 “NIOSH” means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health and Human Services. 

 “Non-enclosed process” means any equipment system (such as an open-top reactor, storage 

tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise 

used where significant direct contact of the bulk chemical substance and the workplace air may 

occur. 

 “Non-industrial use” means use other than at a facility where chemical substances or 

mixtures are manufactured, imported, or processed. 

 “PMN substance” means the chemical substance described in the Premanufacture notice 

submitted by the Company relevant to this Order. 

 “Personal protective equipment” means any chemical protective clothing or device placed 

on the body to prevent contact with, and exposure to, an identified chemical substance or 

substances in the work area. Examples include, but are not limited to, chemical protective 

clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and 

various types of respirators. Barrier creams are not included in this definition. 

 “Process stream” means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

processing, including the cleaning of equipment. 

 “Scientifically invalid” means any significant departure from the EPA-approved protocol 

or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

approval that prevents a reasoned evaluation of the health or environmental effects of the PMN 

substance. 

 “Scientifically equivocal data” means data which, although developed in apparent 

EPA SANITIZED Page 97 of 101
conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are 

inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of 

the potential risk of injury to human health or the environment of the PMN substance. 

“Sealed container” means a closed container that is physically and chemically suitable for 

long-term containment of the PMN substance, and from which there will be no human exposure to, 

or environmental release of, the PMN substance during transport and storage. 

“Use stream” means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

industrial, commercial, or consumer use. 

 “Waters of the United States” has the meaning set forth in 40 CFR 122.2. 

 “Work area” means a room or defined space in a workplace where the PMN substance is 

manufactured, processed, or used and where employees are present. 

 “Workplace” means an establishment at one geographic location containing one or more 

work areas. 

EPA SANITIZED Page 98 of 101
ATTACHMENT B 

ATTACHMENT C 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

___________________________ _________________ 

Company (Transferor) PMN Number 

1. Transfer of Manufacture Rights. Effective on _______________, the Company did sell or 

otherwise transfer to ________________________________, (“Successor in Interest”) the rights 

and liabilities associated with manufacture of the above-referenced chemical substance, which was 

the subject of a premanufacture notice (“PMN”) and is governed by a Consent Order issued by the 

U.S. Environmental Protection Agency (“EPA”) under the authority of §5(e) of the Toxic 

Substances Control Act (“TSCA,” 15 U.S.C. §2604(e)). 

2. Assumption of Liability. The Successor in Interest hereby certifies that, as of the effective date 

of transfer, all actions or omissions governed by the applicable Consent Order limiting 

manufacture, processing, use, distribution in commerce and disposal of the PMN substance, shall 

be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is 

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 

720.22(a)(3). 

3. Confidential Business Information. The Successor in Interest hereby: 

___ reasserts, 

___ relinquishes, or 

___ modifies 

all Confidential Business Information (“CBI”) claims made by the Company, pursuant to Section 

14 of TSCA and 40 CFR part 2, for the PMN substance(s). Where “reasserts” or “relinquishes” is 

indicated, that designation shall be deemed to apply to all such claims. Where “modifies” is 

indicated, such modification shall be explained in detail in an attachment to this Notice of 

Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity 

that was not claimed as CBI by the original submitter) would not subsequently be eligible for 

confidential treatment under this Notice of Transfer.

EPA SANITIZED Page 99 of 101
1 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

___________________________________ _____________________ 

Company (Transferor) PMN Number 

___________________________________ _____________________ 

Signature of Authorized Official Date 

___________________________________ 

Printed Name of Authorized Official 

___________________________________ 

Title of Authorized Official 

___________________________________ 

Successor in Interest

___________________________________ _____________________ 

Signature of Authorized Official Date 

___________________________________ 

Printed Name of Authorized Official 

___________________________________ 

Title of Authorized Official 

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

EPA SANITIZED Page 100 of 101
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued)

___________________________________ 

Successor’s Technical Contact

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

___________________________________ 

Phone 

EPA SANITIZED Page 101 of 101