Support Documents for 

Significant New Use Rules (SNUR) on 

Premanufacture Notice (PMN) 

P-11-160 

EPA Docket EPA-HQ-OPPT-2012-0450 

EPA SANITIZED Page 1 of 61
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-160 

A-002 Initial Review Engineering Report for 

 PMN P-11-160 

A-003 Post Focus Exposure Report for 

 PMN P-11-160 

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

Determinations Supporting Consent Order for 

PMN P-11-160 

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A-001 

Structure Activity Team (SAT) Report 

for PMN P-11-160 

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SAT Report

PMN Number: P-11-0160

SAT Date: 2/1/2011

Print Date: 3/2/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1 3

 Persistence Bioaccum Toxicity Comments

1 11

Exposure Based Review:

Health: Yes

Ecotox: Yes

Routes of exposure: Health: No exposures needed

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: 

Summary of Assessment:

 Fate:

Fate Summary: P-11-0160

FATE: Estimations for typical 

Liquid with MP < 25 C (E)

log Kow = 5.27 (E) 

S = 1.14 mg/L at 25 C (E)

VP = 2.9E-5 torr at 25 C (E)

BP = 378 C (E)

H < 1.00E-8 (E)

log Koc = 4.24 (E)

log Fish BCF = 1.77 (E)

EPA SANITIZED Page 4 of 61
log Fish BAF = 1.09 (E) 

POTW removal (%) = 90 via sorption and biodeg; 92/69/EEC Method C.4-D(Mano Resp): 

 83%/28d.

Time for complete ultimate aerobic biodeg = wk

Sorption to soils/sediments = strong

PBT Potential: P1B1

*CEB FATE: Migration to ground water = slow

 Health:

 Health Summary: Expect poor absorption via all routes (pchem). No 

significant health concerns.

 Test Data: (-) Salmonella with and without activation; rat oral LD0 

= 2000 mg/kg; slight eye irritation in rabbits; slight skin irritation in rabbits, cleared by 72 hours; 

rat 28-day oral NOEL = 1000 mg/kg (highest dose tested)

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 0.66 >100 invalid test

daphnid 48-h LC50 0.88 >100 invalid test

green algal 96-h EC50 0.26 >100 invalid test

fish _ chronic value 0.027

daphnid _ chronic 

value

0.24

algal _ chronic 

value

0.19

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

Ecotox Values Comments: Predictions are based on SARs for SAR chemical class = 

 log Kow = 5.27 (EPI, major product); MW major product); pH7; effective 

concentrations based on 100% active ingredients and mean measured concentrations; hardness 

<180.0 mg/L as CaCO3; and TOC <2.0 mg/L;

Ecotoxicity Study Review for 

PMN P11-0160

Synonyms: None listed

Trade Names: 

Test Lab Designation: 

Three acute ecotoxicity studies were conducted with this PMN (P11-0160) in 2007 by 

 with fish, daphnia, and 

EPA SANITIZED Page 5 of 61
algae. .” 

 Thus, it can be concluded that the 

 in the neat state at room temperature with a purity 

of 93.8% for the 4 major components. The has an estimated water 

solubility of 0.11 mg/L, an estimated log Kow of 5.27, and an estimated vapor pressure of 

0.00029 mmHg at 25°C. 

The 

 After adding the 

, the was blended at high speed (8,000 rpm) with an Ultra Turax blender 

for 60 seconds. Following this, the was stirred for 24 hours using a magnetic stirrer. 

Undissolved particles of the test material were removed first by filtration using a folded filter 

with a pore size of 7 – 12 um. Remaining particles were removed using an aseptic filter with 

pore size of 0.45 um. Attempts to measure the in the test media by gas 

chromatography with a MS detector had limited success due to the low water solubility of the 

test material. The stated Limit of Determination was “< 0.062 mg/L” (presumably this means 

“0.062 mg/L”). Lack of detection was almost certainly due to the negligible 

and possible removal from the aqueous test media by sorption onto the glass 

vessel walls and filters. Thus, concentrations were not reported as measured but as nominal 

loading rates. All three tests were run under static or semi-static conditions. 

In a static limit test, fasted Zebra Fish (Brachydanio rerio) (7 fish/concentration) were exposed to 

nominal concentrations of 0 or 100 mg/L for 96 hours without aeration. Over the course of 

exposures, water temperature ranged from 21.3-22.9°C; pH ranged from 7.5 – 7.9; O2 levels 

ranged from 7.3 – 9.4 mg/L; water hardness was 259 mg as CaCO3/L and electrical conductivity 

was not reported. The 96-hour LC50 for fish was >100 mg/L (nominal); the LOEC was >100; 

and the NOEC was 100 mg/L. No deaths or adverse effects occurred in the control or treated 

fish.

In a 48-hour immobilization limit test, fasted Daphnia magna (5 daphnia/replicate x 4 replicates) 

were exposed to nominal concentrations of 0 or 100 mg/L under semi-static conditions (24-hr 

renewal interval) for a total of 48 hours without aeration. Over the course of the study, 

temperature was maintained at 20.6 – 21.3°C; pH ranged from 7.8 – 8.1; O2 levels ranged from 

8.0 – 8.8 mg/L; water hardness was 268 mg CaCO3/L and conductivity was not reported. The 

48-hour EC50 for daphnia was > 100 mg/L (nominal) with no confidence limits determinable. 

The LOEC for mortality and immobilization was >100 mg/L and the NOEC was 100 mg/L as 

nominal concentrations. Abnormal swimming behavior was observed in 20 of 20 daphnids at 24 

hours and 13 of 20 at 48 hours. In this test, low concentrations were detected and quantifiable at 

the beginning of the test and the beginning of the renewal period (second 24 hrs) but not at the 

end of the 24 hr periods. These levels represented 0.22 – 0.43% of nominals (i.e., 0.22 to 0.43 

mg/L).

In a 72-hour test for algal growth inhibition, an initial cell concentration of 5.0E+3 cells/ml of 

Scenedesmus subspicatus was incubated with the PMN at nominal concentrations of 0, 4.3, 9.4, 

21, 45, or 100 mg/L (not serially diluted) under static conditions (24 hour renewal intervals) for 

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72 hours (3 replicates for both control and treated groups). Corresponding mean measured 

concentrations were not determined due to lack of analytical sensitivity (LOQ < 0.061 mg/L). 

All reported nominal concentrations were above this upper limit estimate of water solubility. 

Cells were exposed continuously to white light with a wavelength between 400 – 700 nm with an 

intensity ranging from 4,000 – 8,000 Lux, with constant swirling (125 rpm) at 23 - 25°C. The 

pH ranged from 8.0 to 9.3; O2 levels were not reported; water hardness and test medium 

conductivity were not reported. The test was conducted in 250 ml Erlenmeyer flasks containing 

100 ml of test solution. Cell growth was measured by a particle cell counter and using uptake of 

a fluorescent dye. This test met validity criteria: algal growth exceeded 16-fold over the 72-hr 

course of exposure in controls, the coefficient of variation of daily growth rates in controls did 

not exceed 35%, and the coefficient of variation of average growth in replicate control cultures 

did not exceed 7%. The 72-hr EbC50 for inhibition of biomass (area under curve), measured as 

nominal concentrations, was 172 mg/L (95% CL: 153-209) with a projected NOEC > 100 mg/L. 

The 72-hr ErC50 for growth rate, measured as nominal concentrations, was > 561 mg/L (95% 

CL: 338-1,883 mg/L) and the NOEC was projected to be greater than 100 mg/L. As in the 

daphnia assay, very low concentrations were quantifiable at the beginning of exposures but fell 

to below detection (i.e., < 0.061 mg/L) by the end of the exposure period.

The three acute ecotoxicity studies are considered invalid due to uncertainty regarding exposure 

concentrations. In these acute assays, the PMN substance does not show significant toxicity. 

However, the appropriateness of conducting acute toxicity test to evaluate a test material of such 

low water solubility is questionable. This is because EC50 values for daphnia and algae and the 

LC50 value for fish are reported at concentrations significantly higher than the estimated water 

solubility limit of the PMN (i.e., 0.11 mg/L). It may have been better to conduct chronic toxicity 

tests such as the 21-day daphnia reproduction assay and the fish early life-stage test wherein the 

PMN would have more time to equilibrate with the test media and biota to yield a more 

meaningful test of ecotoxicity. This would include: 1) Fish Early Life-Stage OCSPP 850.1400 

using if possible, the flow-through method, with mean measured concentrations, protocol review, 

and a certificate of analysis, a.k.a., OECD 210 and; 2) Chronic Daphnia OCSPP 850.1300 using 

if possible, the flow-through method, mean measured concentrations, protocol review, certificate 

of analysis, aka OECD 211. Perhaps better, tests for toxicity to benthic organisms would be best 

since the PMN substance shows such a strong tendency to sorb to organic and inorganic matter 

(e.g., OECD 233 or EPA 850.1735, .1740, .1790, etc). 

Because of these limitations, ECOSAR predictions will be relied upon to determine the 

concentration of concern (COC). ECOSAR predicts a chronic COC of 3 μg/L (ppb) based on 

estimated fish toxicity. An acute COC may be derived from the predicted algae LC50 of 0.26 

mg/L by dividing this value by the default acute to chronic ratio of 4, yielding 0.065 mg/L or 65 

μg/L (ppb).

Ecotox Study Reviewer: S. Cragg

1 February 2011

Factors Values Comments

Assessment Factor 10

Concentration of Concern 3

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(ppb)

SARs

SAR Class new chemicals category: 

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

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A-002 

Initial Review Engineering Report 

for PMN P-11-160 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0160

Focus Ready Draft 2/10/2011

ENGINEER: El-Zoobi \ JD

PV (kg/yr): 

SUBMITTER: 

USE: 

OTHER USES: 

 

CRSS :

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Consumer Use: 

SAT (concerns) (02/01/2011):

Related Cases and Related Cases and Misc SAT Info:

Analogs: ; On TSCA: 

Migration to groundwater:

PBT rating: P1B1T1 .

Health: 1

Eco: 3 Water (All releases to water with a CC = 3.00 ppb)

OCCUPATIONAL EXPOSURE RATING: 2-3B

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claims: 

EXPOSURE-BASED REVIEW: Yes (0 criteria met)

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1) # of workers exposed: 48 >1000? No

2) >100 workers with >10 mg/day inhalation exposure: No

3) (a) >100 workers w/1-10 mg/day inh. exp. & >100

days/yr: No

 (b) Routine Dermal Cont: >250 workers & >100 days/yr:

No

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0160

Processing: 

Number of Sites/ Location: 1

Berry Plastics Corporation Calhoun GA 30701

Days/yr: 250

Basis:

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: 2.0E-3 kg/site-day over 250 days/yr from 1 site

to: City Water System for treatment (per submission).

from: Water Cooling

basis: EPA/OPPT Water Saturation Loss Model.

Water or Incineration or Landfill

Conservative: 3.6E+1 kg/site-day over 250 days/yr from 1

site

Water or Incineration or Landfill

High End: 5.4E+1 kg/site-day over 250 days/yr from 1 site

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 48

Basis: Submission does not estimate number of workers.

Inhalation:

Exposure to Particulate (Class I)

Upper Bound: 3.9E+1 mg/day over 250 days/yr

Number of workers (all sites) with inhalation exposure: 48

Basis:

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? Yes

 OR

 b) Hazard Rating for health of 2 or greater? 1 No

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Liquid at 100.00% concentration

High End: 1.8E+3 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 48

Basis:

Exposure to Solid at 26.00% concentration

High End: 8.1E+2 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 48

Basis:

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0160

Use: 

Number of Sites/ Location: 1

Berry Plastics Corporation Calhoun GA 30701

Days/yr: 250

Basis: 

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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 Air or Incineration or Landfill

Output 2: 9.1E+0 kg/site-day over 250 days/yr from 1 site

Water or Incineration or Landfill

Output 2: 1.8E+1 kg/site-day over 250 days/yr from 1 site

Water or Incineration or Landfill

Output 2: 1.8E+1 kg/site-day over 250 days/yr from 1 site

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 48

Basis: 

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Inhalation:

Exposure to Particulate (Class I)

Upper Bound: 3.9E+1 mg/day over 250 days/yr

Number of workers (all sites) with inhalation exposure: 48

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? Yes

 OR

 b) Hazard Rating for health of 2 or greater? 1 No

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Solid at 26.00% concentration

High End: 8.1E+2 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 48

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A-003 

Post Focus Exposure Report 

for PMN P-11-160 

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10/5/2011 Page 1 of 9 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0160 Reviewer: Kwon/SD 

 

 

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 = 3 

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

Proc: max 

acute eco 

--- --- --- --- 5.41E+01 --- --- --- --- --- --- 

Proc: PDM1 --- --- --- --- 5.41E+01 --- --- --- --- --- 

Proc: PDM2 --- --- --- --- 1.80E-02 --- --- --- --- --- 

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. 

Remarks: 

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

Parameter Exp Based Persistent Exceedance Value 

Drinking (Surface) Water Dose (mg/kg/day) No NA 

Fish Ingestion Dose (mg/kg/day) No NA 

Inhalation Dose (mg/kg/day) No NA 

Groundwater Dose (mg/kg/day) No NA 

Surface Water Release After Treatment (kg/yr) NA 

Total Release After Treatment (kg/yr) NA 

Consumer Use? 

Fate test recommendations?: (default is NA) 

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POST FOCUS EXPOSURE REPORT 

Chemical ID: P-11-0160 Assessor: Kwon/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Proc: Max ADR 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

 

 Non-sludge/Sludge 

Release Days/yr: 

Per Site Release: 

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

Remarks: 

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10/5/2011 Page 3 of 9 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0160 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY:Proc: Max 

ADR 

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 0.00 59.20 

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 50 288.00 123.84 78.18 66.05 1.46 3.39 5.37 6.36 

ALL 10 39.60 13.29 7.76 7.57 10.61 31.61 54.14 55.50 

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 6.79E-06 4.94E-05 mg/kg/day 1.72E-06 1.25E-05 mg/kg/day 

LADCpot 3.48E-04 2.53E-03 mg/L 2.06E-02 0.15 mg/kg 

Acute 

ADRpot 2.83E-04 2.64E-03 mg/kg/day 1.55E-04 1.13E-03 mg/kg/day 

SIC Code Comments: 

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10/5/2011 Page 4 of 9 

 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-11-0160 Assessor: Kwon/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Proc: PDM1 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

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

 

 Non-sludge/Sludge 

Release Days/yr: 

Per Site Release: 

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

Remarks: 

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10/5/2011 Page 5 of 9 

POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0160 

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

SCENARIO #: 2 Number of Sites: RELEASE ACTIVITY:Proc: 

PDM1 

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 0.00 59.20 

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 50 288.00 123.84 78.18 66.05 1.46 3.39 5.37 6.36 

ALL 10 39.60 13.29 7.76 7.57 10.61 31.61 54.14 55.50 

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 6.79E-06 4.94E-05 mg/kg/day 1.72E-06 1.25E-05 mg/kg/day 

LADCpot 3.48E-04 2.53E-03 mg/L 2.06E-02 0.15 mg/kg 

Acute 

ADRpot 2.83E-04 2.64E-03 mg/kg/day 1.55E-04 1.13E-03 mg/kg/day 

SIC Code Comments: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0160 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: Proc: PDM1 

SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

ASSOCIATED SIC CODES: Subset of 4952 

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 

3.00 High 

 Note: 

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 POST FOCUS EXPOSURE REPORT 

Chemical ID: P-11-0160 Assessor: Kwon/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: Proc: PDM2 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

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

 

 Non-sludge/Sludge 

Release Days/yr: 

Per Site Release: 

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

Remarks: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0160 

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY:Proc: 

PDM2 

SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: Adult 

WWT 

REMOVAL 

(%) 

RELEASE 

DAYS 

PRETREATMENT 

RELEASE 

(kg/site/day) 

POSTTREATMENT 

RELEASE 

(kg/site/day) 

DWT 

(%) BCF 

(L/kg) 

 0.00 59.20 

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 50 288.00 123.84 78.18 66.05 4.86E-04 1.13E-03 1.79E-03 2.12E-03

ALL 10 39.60 13.29 7.76 7.57 3.54E-03 1.05E-02 1.80E-02 1.85E-02

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 3.79E-09 2.76E-08 mg/kg/day 9.62E-10 7.00E-09 mg/kg/day 

LADCpot 1.94E-07 1.41E-06 mg/L 1.15E-05 8.37E-05 mg/kg 

Acute 

ADRpot 9.45E-08 8.80E-07 mg/kg/day 5.17E-08 3.76E-07 mg/kg/day 

SIC Code Comments: 

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POST FOCUS EXPOSURE REPORT 

 Chemical ID: P-11-0160 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 3 RELEASE ACTIVITY: Proc: PDM2 

SIC CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) 

ASSOCIATED SIC CODES: Subset of 4952 

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 

3.00 High 

EPA SANITIZED Page 26 of 61
A-004 

TSCA Section 5(e) Consent Order 

and Determinations Supporting Consent Order 

for PMN P-11-160 

EPA SANITIZED Page 27 of 61
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-11-0160 

 ) 

 ) 

 ) 

 ) 

 ) 

_________________________________________________________________ 

Consent Order and Determinations Supporting Consent Order 

_________________________________________________________________

EPA SANITIZED Page 28 of 61
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 Environmental 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. Successor Liability Upon Transfer of Consent Order 

V. Modification and Revocation of Consent Order 

VI. Effect of Consent Order 

Attachment A - Definitions 

 Attachment B - Notice of Transfer of Consent Order 

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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-11-0160 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: 

(a) submit to EPA certain toxicity testing at least 14 weeks before manufacturing or importing a 

total of [ ] of the PMN substance and 

(b) not use the PMN substance for anything other than as [

]. 

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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): submitter, 

chemical identity, production volume, use, processing and use operations information, MSDS, 

and test data 

Chemical Identity:

Specific: [ ] 

Generic: acetylated fatty acid glycerides 

Use:

Specific: [

Generic: open, non-dispersive (resin) 

Maximum 12-Month Production Volume: [ ] 

Test Data Submitted with PMN: health effects, environmental effects, physical/chemical 

properties 

IV. EPA'S ASSESSMENT OF RISK

 The following are EPA's predictions regarding the probable toxicity and environmental 

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

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Environmental Effects Summary: 

ECOSAR predicts a chronic COC of 3 μg/L (ppb) based on estimated fish toxicity. An acute 

COC may be derived from the predicted algae LC50 of 0.26 mg/L by dividing this value by the 

default acute to chronic ratio of 4, yielding 0.065 mg/L or 65 μg/L (ppb). Predictions are based 

on SARs for esters; log Kow = 5.27; MW 358; pH7; effective concentrations based on 100% 

active ingredients and mean measured concentrations; hardness <180.0 mg/L as CaCO3; and 

TOC <2.0 mg/L. See www.epa.gov/opptintr/newchems/pubs/chemcat.htm

Environmental Release Summary: 

 Process 

Number of Sites 

Release to Water 

(kg/day) 

0.2 

Surface Water 

Concentration (ppb) 

26 

Days Exceeding Concern 

Level 

14 

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 chronic aquatic toxicity from environmental 

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

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that the information available to the Agency is insufficient to permit a reasoned evaluation of the 

environmental effects of the PMN substance. 

(b) In light of the potential risk of chronic aquatic toxicity 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 the environment. 

(c) In light of the estimated production volume and environmental release of the PMN 

substance, EPA has further concluded, pursuant to § 5(e)(1)(A)(ii)(II) of TSCA, that the PMN 

substance will be produced in substantial quantities and may reasonably be anticipated to enter 

the environment in substantial quantities. 

VI. INFORMATION REQUIRED TO EVALUATE ENVIRONMENTAL EFFECTS

 Triggered Testing. The Order prohibits the Company from exceeding a specified 

production volume unless the Company submits the information described in the Testing section 

of this Order in accordance with the conditions specified in the Testing section. 

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CONSENT ORDER

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

distribution in commerce, use and disposal of the chemical substance [

] (P-11-0160)(“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 of the 

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 

of the following exemptions, and (2) such compliance is documented by appropriate 

recordkeeping as required in the Recordkeeping section of this Order. 

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(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) or entrained in a film. 

(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). 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 

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 

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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 

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 

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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 the PMN substance in the United States, 

for any nonexempt commercial purpose, pending the development of information necessary for a 

reasoned evaluation of the chronic aquatic environmental effects 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. 

(b) Notice of Study Scheduling. The Company shall notify, in writing, the Monitoring Assistance 

and Media Programs Division (2227A), Office of Enforcement and Compliance Assurance, U.S. 

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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 should obtain guidance from EPA on the adequacy of the test protocols to address the 

outstanding safety issues by submitting written protocols to EPA. 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. EPA guidance regarding the adequacy of a test protocol does not mean preacceptance of test results. 

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(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or 

importing the PMN substance beyond the following aggregate manufacture and import volumes 

("the production limits"), unless the Company conducts the following studies on the PMN 

substance and submits all final reports and underlying data in accordance with the conditions 

specified in this Testing section. 

Production Limit Study Guideline

 Daphnid chronic toxicity test OPPTS Test Guideline 

(Flow through conditions/ 850.1300 

 measured concentrations) 

Fish early-life stage toxicity test OPPTS Test Guideline 

(Flow through conditions/ 850.1400 

 measured concentrations) 

The special considerations for conducting Aquatic Laboratory Studies (OPPTS 850.1000) should 

be used. 

(e) 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 require the submission of raw data such as 

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slides and laboratory notebooks only 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. 

(f) 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. 

(g) 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 

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

mutual consent of EPA and the Company. 

(h) 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). 

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 (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. 

(i) 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 

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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 

report and data, as to whether the Company may continue to manufacture and import beyond the 

applicable production limit. 

(j) 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 

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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's response or cease all manufacture, import, processing, distribution, use and disposal of the 

PMN substance. 

(k) 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. 

USE

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(a) The Company shall not use the PMN substance other than as 

]. 

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. 

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

entrained in a film), 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: 

 (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. 

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

until after the PMN substance has been completely reacted (cured) or entrained in a film. 

 (3) Not use the PMN substance other than as described in the PMN, as [

. 

(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 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 

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

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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. 

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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 

section 11 of TSCA: 

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 (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; 

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 (4) Records documenting the address of all sites of manufacture, import, processing, and 

use; 

 (5) Records documenting compliance with any applicable use restrictions in the Use 

section of this Order; 

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

section of this Order, if applicable; and, 

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

substance is manufactured or imported. 

(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

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(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; 

 (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 

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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 

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. 

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(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). 

 (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 B 

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: 

EPA SANITIZED Page 52 of 61
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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 

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 paragraph (d) of 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 

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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 

environmental effects or environmental release of 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 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. 

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EPA SANITIZED Page 55 of 61
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. 

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 “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. 

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 “Scientifically equivocal data” means data which, although developed in apparent 

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, 

nor 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. 

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ATTACHMENT B 

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.

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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 

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TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued)

___________________________________ 

Successor’s Technical Contact

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

___________________________________ 

Phone 

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