Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-63 

EPA Docket EPA-HQ-OPPT-2012-0450 

EPA SANITIZED Page 1 of 72
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-63 

A-002 Initial Review Engineering Report for 

 PMN P-11-63 

A-003 Initial Review Exposure Report for 

 PMN P-11-63 

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

Determinations Supporting Consent Order for 

PMN P-11-63 

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A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-63 

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SAT Report

PMN Number: P-11-0063

SAT Date: 11/19/2010

Print Date: 3/2/2012

Related cases:

Health related cases: 

Ecotox related cases: Analogs: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 1 Health: PMN ; Eco: parent substance

2 3 Health: Incineration/degradation product ; Eco: toxicity of oncomplete 

incineration products to terrestrial organisms

 Persistence Bioaccum Toxicity Comments

3 1 1 PMN

3 2 2

Exposure Based Review:

Health: Yes Exposure based testing (health): Inhalation only

Ecotox: No

Routes of exposure: Health: Inhalation 

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: LUNG

Summary of Assessment:

 Fate:

Fate Summary: P-11-0063

FATE: MW = 

Solid

S = Negl.

VP < 1.0E-6 torr at 25 C (E)

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 90 via sorption

Time for complete ultimate aerobic biodeg > mo

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Sorption to soils/sediments = v.strong

PBT Potential: PMN 

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes based on physical/chemical 

properties. There is concern for lung overload and waterproofing of the lungs if respirable 

particles are inhaled based on the high molecular weight of the PMN compound (MW = 

and its use as a stain repellent with a side chains. Low moderate concern. 

For the potential incomplete incineration product, based on test data for the analogue 

acid concerns are liver toxicity, blood toxicity, and male reproductive toxicity 

[rat 28-day oral NOAEL = 50 mg/kg, LOAEL = 150 mg/kg with liver toxicity; rat 90-day oral 

LOAEL = 10 mg/kg based on decreased body weight in males at all doses and liver toxicity and 

anemia at 200 mg/kg; there were toxic effects on the testes in 2 males in the 90-day oral study 

that were judged by the reviewer to be indicative of the potential for male reproductive toxicity. 

There is also concern for immunosuppression and oncogenicity based on data for and 

 Test Data: negative in Salmonella and E coli

acute oral study in rats - no deaths or signs of toxicity at 2000 mg/kg

not a skin irritant

not an eye irritant

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 *

daphnid 48-h LC50 *

green algal 96-h EC50 *

fish _ chronic value *

daphnid _ chronic 

value

*

algal _ chronic 

value

*

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

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

chemical class = ; MW 

 solid with unknown mp (P); S < 0.001 mg/L at 25 C (P); pH7; effective 

concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 

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

EPA SANITIZED Page 5 of 72
high concern for the : to wild mammals and birds based on 

mammalian test data for mammals for .

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

*

SARs

SAR Class new chemicals category: none

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

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A-002 

Initial Review Engineering Report 

 for PMN P-11-63 

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INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0063

Focus Ready Draft 12/9/2010

ENGINEER: Avcin \ BCS \ DGR \ CLM

PV (kg/yr): 

Revision Notes / Assessment Overview: 

SUBMITTER: 

USE:

OTHER USES: 

 

CRSS :

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Consumer Use: 

SAT (concerns) (11/19/2010):

Related Cases and Related Cases and Misc SAT Info:

Ecotox: Analogs: 

Migration to groundwater: Negligible

PBT rating: P3B2T2 PMN: P3B1T1; incineration/degr product:

 P3B2T2

Health: 2 Inhalation, XB Testing (Testing desired)

Eco: 3 No releases to Water, XB Testing (No Testing

desired)

OCCUPATIONAL EXPOSURE RATING: 1-2C

NOTES & KEY ASSUMPTIONS:

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

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POLLUTION PREVENTION CONSIDERATIONS:

P2 Claims: 

EXPOSURE-BASED REVIEW: Yes (1 criteria met)

1) # of workers exposed: 450 >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:

Yes

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0063

USE: 

Number of Sites/ Location: 15

unknown sites

Days/yr: 250

Basis:

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: 

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Water

Output 2: 5.8E+0 kg/site-day over 250 days/yr from 15

sites

Water or Incineration or Landfill

Output 2: 4.8E+0 kg/site-day over 250 days/yr from 15

sites

Incineration

High End: 1.9E+0 kg/site-day over 192 days/yr from 15

sites

RELEASE TOTAL

4.5E+4 kg/yr - all sites

7

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 450

Basis:

Inhalation:

Exposure to Particulate (Class I)

Low End of Range: 2.9E-2 mg/day over 250 days/yr

High End of Range: 1.9E-1 mg/day over 250 days/yr

Number of workers (all sites) with inhalation exposure:

Basis: Roll Coating; EPA/OPPT UV Roll Coating Inhalation

NOTE: The respirator class is: I. Particulate (including

solid or liquid droplets).

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 Yes

Inhalation Monitoring Data Desired? Yes (both criteria

met)

Dermal:

Exposure to Liquid at 30.00% concentration

High End: 5.3E+2 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 450

Basis:

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A-003 

Initial Review Exposure Report 

 for PMN P-11-63 

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12/8/2010 Page 1 of 12 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0063 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 = 

1000 

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 

Use: Max 

ADR: max 

acute eco 

6.33E-03 --- --- --- 1 .30E+02 --- --- 8.29E-03 --- --- --- 

Use: PDM1 --- --- --- --- 1.30E+02 --- --- --- --- --- 

Use: Max 

LADD 

--- 1 .06E-04 --- --- --- --- --- --- 4.25E-04 --- --- 

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) Yes Yes 6.33E-03 

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

Inhalation Dose (mg/kg/day) Yes Yes 8.29E-03 

Groundwater Dose (mg/kg/day) No No 

Surface Water Release After Treatment (kg/yr) 

Total Release After Treatment (kg/yr) 

Consumer Use? 

Fate test recommendations?: (default is NA)

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0063 Assessor: Kwon/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: Use: Max ADR 

 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0063 

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

SCENARIO #: 1 Number of Sites: RELEASE ACTIVITY:Use: 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) 

 0.00 0.00 

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 6.00 14.09 22.71 27.50 

ALL 10 19.84 75.77 129.58 154.97 

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 3.21E-05 1.06E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 1.65E-03 5.44E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.18E-03 6.33E-03 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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12/8/2010 Page 4 of 12 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0063 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY:Use: Max ADR 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 

Per Site Fugitive Release: kg/site/day 

Fugitive Release Days per Year: days 

% Removal via Fugitive Release: % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

0.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

0.00 μg/m3

Per Site Stack Release: kg/site/day 

Stack Release Days per Year: days 

% Removal via Stack Release: % 

Total Stack Release: kg/yr 

Max Annual Average Air Concentration (Stack): 4.75 μg/m3

Max 24 Hour Average Air Concentration (Stack): 45.10 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 3.49E-04 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 1.90E-03 N/A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 8.29E-03 N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

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12/8/2010 Page 5 of 12 

 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

N/A 

Stack Gas 

Temperature: 

293.00 K 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0063 Assessor: Kwon/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: Use: 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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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0063 

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

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

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) 

 0.00 0.00 

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 6.00 14.09 22.71 27.50 

ALL 10 19.84 75.77 129.58 154.97 

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 3.21E-05 1.06E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 1.65E-03 5.44E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.18E-03 6.33E-03 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0063 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: Use: 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 

1000.00 High 

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 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0063 Assessor: Kwon/SD 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: Use: Max LADD 

 Release Description: WATER LANDFILL 

Non-sludge/Sludge 

STACK FUGITIVE 

Total Releases: 

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

 

 Non-sludge/Sludge 

Release Days/yr: 

Per Site Release: 

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

Remarks: 

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INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0063 

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

SCENARIO #: 3 Number of Sites: RELEASE ACTIVITY:Use: 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) 

 0.00 0.00 

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 N/A N/A N/A N/A 

ALL 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 3.21E-05 1.06E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 1.65E-03 5.44E-03 mg/L 0.00 0.00 mg/kg 

Acute 

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

SIC Code Comments: 

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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0063 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 3 RELEASE ACTIVITY:Use: Max LADD 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 

Per Site Fugitive Release: kg/site/day 

Fugitive Release Days per Year: days 

% Removal via Fugitive Release: % 

Total Fugitive Release: kg/yr 

Max Annual Average Air Concentration 

(Fugitive): 

0.00 μg/m3

Max 24 Hour Average Air 

Concentration(Fugitive): 

N/A μg/m3

Per Site Stack Release: kg/site/day 

Stack Release Days per Year: days 

% Removal via Stack Release: % 

Total Stack Release: kg/yr 

Max Annual Average Air Concentration (Stack): 5.78 μg/m3

Max 24 Hour Average Air Concentration (Stack): N/A μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 4.25E-04 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 2.31E-03 N/A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) N/A N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

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 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

N/A 

Stack Gas 

Temperature: 

293.00 K 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

EPA SANITIZED Page 25 of 72
A-004 

TSCA Section 5(e) Consent Order 

and Determinations Supporting Consent Order 

for PMN P-11-63 

EPA SANITIZED Page 26 of 72
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

 In the matter of: ) Premanufacture Notice Number: 

 ) 

 ) 

 ) 

 ) 

 ) 

 [ ] ) P-11-0063 

 

 ) 

 ) 

 ) 

 ) 

 ) 

_________________________________________________________________ 

Consent Order and Determinations Supporting Consent Order 

_________________________________________________________________ 

EPA SANITIZED Page 27 of 72
ii 

TABLE OF CONTENTS 

Preamble

I. Introduction 

II. Summary of Terms of the Order 

III. Contents of PMN 

IV. EPA’s Assessment of Exposure and Risk 

V. EPA’s Conclusions of Law 

VI. Information Required to Evaluate Human Health and 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. 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 - Notice of Transfer of Consent Order 

EPA SANITIZED Page 28 of 72
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-11-0063 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 the PMN substance requires the Company to: 

(a) analyze and report [ ] impurities from the 

]; 

 (b) not exceed certain maximum established levels of [ impurities; 

EPA SANITIZED Page 29 of 72
iv 

(c) submit to EPA certain fate and product properties testing at least 14 weeks before 

manufacturing or importing a total of [ of the PMN substance; 

(d) not use the PMN substance in consumer products with spray applications; and 

(e) maintain certain records. 

EPA SANITIZED Page 30 of 72
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 

identity; technical contact; chemical identity; impurities; synonyms; trade identification; 

byproducts; production volume; operation descriptions, including exposure and release 

estimates; pollution prevention; physical/chemical properties; and test data. 

Chemical Identity:

Specific: [

 Generic: Perfluoroalkyl acrylate copolymer 

Use:

Specific: Coating material for uses in textiles and/or paper 

Maximum 12-Month Production Volume: [ ] kg/yr 

Test Data Submitted with PMN: health effects, physical/chemical properties, structure/activity 

relationships 

EPA SANITIZED Page 31 of 72
vi 

IV. EPA’S ASSESSMENT OF EXPOSURE AND RISK

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

and environmental release of the PMN substance, based on the information currently available to 

the Agency. 

Human Health Effects Summary: EPA has concerns about potential fluorinated incineration or 

other decomposition products of the PMN substance. EPA also has concerns that the PMN 

substance under some conditions of use--particularly non-industrial, commercial, or consumer 

use--could cause lung effects, based on limited data on some perfluorinated compounds. 

 An acute inhalation study in rats, with dose levels of 0.61 and 5.9 mg/L over a 4 hour 

exposure period, was received on a close analog. The approximate lethal concentration was 

estimated to be greater than 5.9 mg/L, which is consistent with a low concern for acute inhalation 

toxicity. 

 EPA expects that the PMN substance will degrade, based on data on 

]. The PMN substance may degrade to [

]. 

 Based on available information, EPA has determined that the PMN substance may have 

[ ] impurities. The Company has arranged 

for the raw material supplier to annually test the [ starting raw material for [

] impurities and 

 impurities and report those results to the 

Company in a Certificate of Analysis. Further, the raw material supplier will annually test the 

EPA SANITIZED Page 32 of 72
vii 

[ ] starting raw material for [ ], including 

establishing calibration curves where the level of quantification desired is [ . 

 EPA is concerned that these perfluorinated products may be released to the environment 

from incomplete incineration of the PMN substance at low temperatures. EPA has preliminary 

evidence, including data on other [ ], suggesting that the PMN substance 

could degrade in the environment, under some conditions. Based on data on chemicals 

analogous to potential degradants of the PMN substance, including PFOA and [

], EPA has concerns that potential degradation products from this PMN 

substance will persist in the environment, could bioaccumulate or biomagnify, and could be toxic 

to people, wild mammals, and birds (“PBT”). The presumed perfluorinated degradants for the 

PMN substance include ]. There is limited toxicological data in animals on [ ] or 

precursors, which is summarized below. EPA has some indication that a minor photolytic 

pathway could yield [ EPA does not have toxicity data on 

[ ]. 

 PFOA is expected to persist for years in the environment. Biodegradation and photolysis 

tests of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl 

compounds. Bioaccumulation concerns are based on the measured presence of certain 

perfluoroalkyl compounds, including PFOA, in wildlife and in human blood samples. Toxicity 

studies on PFOA indicate developmental, reproductive and systemic toxicity in various species, 

as well as possible cancer concerns. These factors, taken together, raise concerns for potential 

adverse chronic effects in humans and wildlife. For additional information about PFOA, consult 

the EPA regulatory docket at OPPT-2003-0012. Additional information about PFOA, [ ], 

and other perfluorinated substances may also be found in the Administrative Record for PFOS, 

EPA SANITIZED Page 33 of 72
viii 

PFOA, and Telomers and Related Chemicals (AR-226). Administrative Record (AR-226) is not 

currently available online, but copies can be requested on CD-ROM from the EPA Docket office 

by calling (202) 566-0280 or sending an email request to oppt.ncic@epa.gov. 

 Limited toxicological, ecological, and fate data now exist on [ ] and some of the 

]-derived polymers and other substances; see the PMN docket for data for these specific 

PMNs. EPA previously received a pharmacokinetics study on [ ] and, for comparison, 

perfluorobutane sulfonate (“PFBS”) in the Cynomolgus Monkey. This study indicates that the 

serum half-life of [ is less than 24 hours in these monkeys. In comparison, the serum 

half-life of PFOA has been shown to be 20.9 days in female monkeys and 32.6 days in male 

monkeys. In addition, the serum half-life of PFOA in humans is approximately 3.8 years. 

Another pharmacokinetics study on [ ] in rats showed a serum half-life of one hour or 

less. These data support the assessment of reduced bioaccumulation of [ ] relative to 

PFOA. 

 In 2007, EPA received a 90-day study with a reproduction screen on [

] with dose levels of 0, 20, 100, and 500 mg/kg/day. EPA’s review of this study 

concluded that a no-observed adverse effect level (“NOAEL”) was not established in this study 

for systemic effects. Nasal tissue, liver, and thyroid effects were observed at 100 and 500 

mg/kg/day; while body weight, red blood cell system, clotting and kidney effects were observed 

at 500 mg/kg/day. The EPA reviewer concluded that, although not clearly dose related, the 

elevation of two markers for liver toxicity across all treated groups of males in clinical chemistry 

and focal necrosis in the liver, across all treated groups of males, as well as in treated recovery 

males, and the absence of this result in the controls, leads to the conclusion that no NOAEL was 

achieved. 

EPA SANITIZED Page 34 of 72
ix 

 For the one-generation reproductive toxicity component of this study, the reproductive 

toxicity NOAEL is 500 mg/kg/day (the highest dose tested). The systemic toxicity NOAEL for 

P1 rats was 20 mg/kg/day based on decreased body weights/body weight gains at 100 and 500 

mg/kg/day. The systemic toxicity for F1 adults is 100 mg/kg/day based on reduced body 

weights/body weight gains and reduced food consumption at 500 mg/kg/day. The 

developmental toxicity NOAEL for F1 pups was 100 mg/kg/day based on decreased pup weights 

at 500 mg/kg/day. The rats (P1 generation; 20/sex/group) were administered gavage doses of 0, 

20, 100 or 500 mg/kg/day for 70 days pre-mating, and then mated for a maximum of 2 weeks to 

produce 1 litter. Dosing was continued during mating, gestation, and lactation. 

 In 2005, a Combined Repeated-Dose Toxicity Study with Reproduction/Developmental 

Screening Test (OECD 422) in rats was conducted on ]. The EPA review of these 

subchronic and reproductive data on [ ] concluded that for [ ], no reproductive 

effects were seen at 50, 150, and 450/300 mg/kg/day (450 was reduced to 300 in the study on 

day 4 because of toxicity) dose levels; however, systemic effects--primarily liver effects--were 

seen. EPA review places the NOAEL for [ at 50 mg/kg/day. 

 In 2006, another 90-day oral repeated dose toxicity study (OECD 408) was submitted 

with dose levels of 0 (vehicle control), 10, 50, or 200 mg/kg/day, based on the previous 

Combined Study (OECD 422). EPA review sets the Lowest-Observed Effect Level (“LOEL”) or 

LOAEL at 10 mg/kg/day, based on the lower body weight gains in all treated groups of males. 

There was treatment-related toxicity in the liver and the red blood cell system (anemia) in males, 

as well as increased peroxisomal beta oxidation activity at 200 mg/kg/day. Hepatotoxicity and 

peroxisomal beta oxidation activity have been observed in studies on PFOA. 

EPA SANITIZED Page 35 of 72
x 

 The significance of the finding of a benign brain tumor (astrocytoma) in one male rat in 

the high dose group is not clear. The tumor is not the type normally associated with PFOA-type 

compounds, is not rare, and may be incidental. Abnormal histopathology observations in the 

testes of 2 males and epididymides of 1 male at the 200 mg/kg/day dose level are a sign of male 

reproductive toxicity. Further studies should investigate male reproductive effects. From this 

study, the potential for immunotoxic effects is low, in contrast to some studies showing 

immunotoxic effects from PFOA. Any investigation of immunotoxic effects should await the 

corroborative studies now being conducted by EPA’s Office of Research and Development. 

There were no clinical signs of neurotoxicity and there were no treatment-related effects in the 

functional observation battery or motor behavior. 

 Another 90-day study on [ ] concluded that blood and liver effects were seen at the 

highest dose, with doses comparable to those in other studies. 

 A one-generation reproduction/developmental toxicity study in mice on the [

] was submitted to the Agency. In this study, pregnant mice were administered the 

test substance via gavage during gestation days (GD) 6-18. The NOAEL for maternal toxicity 

was 175 mg/kg/day (the highest dose tested). Signs of developmental toxicity were observed at 

175 mg/kg/day on postnatal day 1 and consisted of increases in the number of stillborn pups and 

pup deaths, reductions in the average pup body weight per litter, with two litters having one pup 

each with corneal opacity and microphthalmia, and one litter with a pup with lenticular opacity. 

The NOAEL for developmental toxicity is 35 mg/kg/day. 

 These and other data indicate a different and less toxic profile for [ ], (a presumed 

environmental degradant of the PMN substance), than for PFOA. However, based on: (1) the 

persistence of [ ; (2) potential intermediate fate products; and, (3) the possibility or 

EPA SANITIZED Page 36 of 72
xi 

likelihood that this substance may be used as a major substitute for some uses of PFOA, EPA 

believes that more information is needed on the toxicity of [ ] and possibly other 

environmental degradants, and the fate and physical/chemical properties of [ -derived or 

related polymers in the environment. 

 EPA also believes that additional reproductive and long-term toxicological studies on 

[ ] in animals are warranted. EPA has received a 90-day Repeated Dose study with 

Reproductive Screening and a two year oral toxicity study conducted by other companies. 

Further, EPA expects that a modified reproductive test (OECD 421) will be conducted by 

another company. The modifications for the reproductive test include: (1) increase the parental 

sample size to 20, (2) the duration of the study should be extended to until the pups have reached 

sexual maturation, (3) parental males should be dosed for 10 weeks prior to mating, (4) dosing of 

the parental animals should be continued through lactation and then the pups should be directly 

dosed until they reach sexual maturation, (5) pup body weight should be recorded on lactation 

days 0, 4, 7, 14, and 21 and then at weekly intervals, (6) litter size can be standardized to 4 

pups/litter on lactation day 4 (optional), (7) at weaning one pup/sex/litter can be randomly 

selected to follow until sexual maturation, and (8) the time of sexual maturation should be 

recorded (i.e. vaginal opening and preputial separation). EPA also expects that a Combined 

Carcinogenicity/Chronic Toxicity test (OPPTS 870.4300 or OECD 453) and an avian 

reproduction test (OECD 206) in bobwhite quail will be conducted by another company. EPA 

may still seek an additional avian reproduction study (OECD 206) in mallard ducks; as well as 

comparative data. In addition, pharmacokinetics of [ and other perfluorinated 

substances will be developed in testing conducted by the National Technology Program in the 

so-called Perfluoro Class Study. 

EPA SANITIZED Page 37 of 72
xii 

 EPA believes that characterization of the PMN substance would be valuable. Limited 

testing is triggered in this order to characterize the PMN substance. 

Environmental Effects Summary: EPA expects the PMN substance or the degradants to be 

highly persistent. 

There is expected to be a low concern for environmental risk to the intact PMN substance 

based on similar [ ]. There is concern for terrestrial species for the 

potential ultimate degradation product based on PFOA and PFOS. 

 There is also high concern for possible environmental effects from the potentially 

persistent degradation product [ . As stated previously, an analog of [ , PFOA, is 

persistent in the environment, has a long bioretention time in various species, has been detected 

in a number of species of wildlife, including marine mammals, and is considered toxic to 

mammalian and other species. The toxicological properties and presence of PFOA in the 

environment continue to be investigated. While EPA has limited acute ecotoxicological effects 

data on [ ] in fish, daphnia, and algae, additional chronic data on [ ] is desired. 

EPA anticipates these tests are being conducted by other companies. 

Exposure and Environmental Release Summary: Thermal and simulated incineration testing 

exists on some related polymers. This testing indicates that incomplete incineration products are 

formed at lower incineration temperatures. Modified Zahn-Wellens and Semi-Continuous 

Activated Sludge (“SCAS”) biodegradation tests have been conducted on some related polymers. 

EPA has determined that some related polymers degrade, while another did not show signs of 

degradation during the time frame of the test. EPA has received and reviewed test data showing 

EPA SANITIZED Page 38 of 72
xiii 

that certain polymers with perfluoroalkyl substituents degrade to form perfluoroalkyl-containing 

intermediates and perfluoroalkyl-containing organic acids. EPA expects that the PMN substance 

will degrade in this way. 

Exposure and Release Summaries:

95% of the PMN substance will be imported in the formulated product, while 5% of the 

PMN substance will be processed domestically. The processing step of [ ] will take 

place at [ ]. Occupational exposures are 

. [

] All releases of the PMN substance to the environment during processing [ 

] 

Use as [

. Occupational exposures expected include [ . [

]. [

. Environmental releases during use are [

]. 

V. EPA’S CONCLUSIONS OF LAW

The following findings constitute the basis of the Consent Order: 

EPA SANITIZED Page 39 of 72
xiv 

(a) EPA is unable to determine the potential for human health and environmental effects from 

exposure to the PMN substance and potential degradation products. 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 and environmental effects of the PMN 

substance and potential degradation products. 

(b) In light of the potential risk of human health and environmental 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 and the environment. 

(c) In light of the estimated production volume of, and human exposure to, the PMN substance 

and potential degradation products, 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, and there may be significant (or 

substantial) human exposure to the substance and potential degradation products. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH 

AND 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. 

EPA SANITIZED Page 40 of 72
xv 

Pended Testing. The Order does not require submission of the pended testing listed 

below 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 expects that protocols would be submitted 

prior to any additional testing. Due to the limited water solubility of some of these substances 

and consequent analytical difficulties, some modification of the protocols may be necessary. 

These and other modifications will be agreed upon between EPA and the Company. 

The following tests on the PMN substance would be necessary to evaluate the 

environmental fate and transport and health effects: 

Test Description Guideline

Anaerobic Biodegradability of Organic 

Compounds in Digested Sludge 

 OECD 311 

Phototransformation of Chemicals on Soil 

Surfaces–2 soils 

 Draft OECD Guideline Jan. 

2002 

Simulation Test-Aerobic Sewage Treatment 

(Activated Sludge Units) 

 OECD 303A 

Aerobic and Anaerobic Transformations in 

Aquatic Sediment Systems 

 OECD 308 

Reproduction/Developmental Toxicity 

Screening Test 

 OPPTS 870.3550 modified 

for [ 

Combined Chronic Toxicity/Carcinogenicity OPPTS 870.4300 

EPA SANITIZED Page 41 of 72
CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS

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

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

] (P-11-0063) (“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. 

(1) 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 

EPA SANITIZED Page 42 of 72
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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 

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

Testing section of this Order. 

(2) 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). 

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

they are 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). 

(4) 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. 

(5) 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 

EPA SANITIZED Page 43 of 72
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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 

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 non-exempt commercial purpose, pending the development of information necessary for a 

reasoned evaluation of the human health and 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. 

CHEMICAL SYNTHESIS AND COMPOSITION

(a) Restriction and testing.

(1) The company shall not manufacture the PMN substance for non-exempt commercial 

purposes unless annual testing of the [ ] starting raw material, as supplied by the raw 

material supplier in the Certificate of Analysis, meets the established purity levels as specified in 

Table 1 of this Order. 

EPA SANITIZED Page 44 of 72
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(2) The company shall not manufacture the PMN substance for non-exempt commercial 

purposes unless annual testing of the [ ] starting raw material, as supplied by the raw 

material supplier in the Certificate of Analysis, meets the established purity levels as specified in 

Table 2 of this Order. 

(3) (i) If, within one year before the date of commencement of non-exempt commercial 

manufacture of the PMN substance, a product that contained [ products was 

processed or manufactured in the same equipment at the facility where the PMN substance is to be 

made, the Company shall annually test the Initially Isolated Formulations Containing the PMN 

Substance for the analytes specified in Table 3 of this Order. This testing shall be conducted upon 

initial commencement of non-exempt manufacture or import of the PMN substance at each 

manufacturing facility and annually thereafter, until one (1) year after the date of the last 

manufacture or processing of a product that contains [ ] products at that facility. 

Thereafter, no further testing of Initially Isolated Formulations Containing the PMN Substance 

shall be required provided that there is no subsequent or new manufacture or processing of a 

product that contains [ ] products in the same equipment at the facility where the PMN 

substance is to be made. 

(ii) If any new manufacturing facility is added or if the process of manufacture of 

the PMN substance or any intermediate thereof is significantly altered, then the Initially Isolated 

Formulations Containing the PMN Substance must be tested at the commencement of these actions 

and annually thereafter (as shown in Table 3). 

(iii) The Company shall submit all test protocols to EPA for review prior to 

initiating testing of Initially Isolated Formulations Containing the PMN Substance as set forth in 

(3)(i) and (3)(ii) above. 

EPA SANITIZED Page 45 of 72
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(b) Recordkeeping. 

(1) The Company shall record the levels of impurities, tested in accordance with paragraph 

(a), associated with the PMN substance manufactured by the Company, as specified in (2) - (4) 

below. 

(2) The Company shall record those analytes present in the [ at each 

manufacturing facility using this raw material (as shown in Table 1) as set forth in (a)(1) above. 

(3) The Company shall record the analyte [ present in the 

[ ] starting raw material (as shown in Table 2) as set forth in (a)(2) above. 

(4) The Company shall record the analytes in the Initially Isolated Formulations Containing 

the PMN Substance (as shown in Table 3) as set forth in (a)(3) above. 

(c) Foreign Manufacture of the PMN Substance. If the PMN substance is imported, the Company 

shall obtain from the foreign manufacturer written documentation to certify that representative 

samples of the [ and Initially Isolated Formulations Containing the PMN Substance 

have been tested consistent with the requirements of paragraph (a). 

(d) Reporting. 

(1) The Company shall report the results of testing under paragraph (a) to EPA at initial 

commencement of non-exempt manufacture or import and then annually thereafter. 

(2) In addition, the Company shall, for the [ ] starting raw material, annually 

report the average values and range of values, including outlying data, obtained through annual 

testing in accordance with paragraph (a)(1). 

EPA SANITIZED Page 46 of 72
- 6 - 

TABLE 1: Chemicals to be Tested at Least Annually in the [ ] 

Analyte CAS Registry 

Number Maximum Limit 

[ ] [ )] 

[

[ ] 

[ 

[ 

[

[

[

[

[

[

[ 

[ 

[ 

[ 

[ 

[ ] 

TABLE 2: Chemicals to be Tested at Least Annually in the [ ] 

Analyte CAS Registry 

Number 

Maximum Limit 

[ [ 

TABLE 3: Chemicals to be Annually Tested in the Initially Isolated Formulations Containing the 

PMN Substance 

Analyte CAS Registry 

Number Maximum Limit 

[ ] 

[

[ 

[

[ [ [ 

EPA SANITIZED Page 47 of 72
- 7 - 

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 EPA Monitoring 

Assistance and Media Programs Division (2227A), 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 

EPA SANITIZED Page 48 of 72
- 8 - 

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 study, the Company 

must obtain approval of test protocols from EPA 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 approval of a test protocol does not mean preacceptance of test results. 

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

importing the PMN substance beyond the aggregate manufacture and import volume (“the 

production volume limit”) of 406,000 kilograms, unless the Company conducts the following three 

listed studies on the PMN substance and submits all final reports and underlying data in 

accordance with the conditions specified in this Testing section. 

1) Combined Direct and Indirect Photolysis with Hydrolysis Study on the commercial 

dispersion without UV stabilizer: For the indirect photolysis samples, use humic acid. To 

observe hydrolysis activity, substitute dark controls in the indirect photolysis test. The 

analytes will be: 

Analyte CAS Registry Number 

[ ] 

[ [ 

 [ 

[ [ 

[ ] 

[ ] [ 

EPA SANITIZED Page 49 of 72
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If it is infeasible to quantitatively analyze [ ] (CAS Registry Number 

) and [ (CAS Registry Number [ ]), then 

non-quantitative monitoring may be implemented instead. 

2) Highly Modified OECD 302B Test: The test period will be 56 days or longer. Higher 

inoculum-to-substrate levels and periodic fresh feed of the inoculum will be used. The 

analytes will be: 

Analyte CAS Registry Number 

[ ] [ 

[ [

[ ] [

[ ] [ 

[ ] [

[ [

[ [ 

[ ] [ 

3) Accelerated weathering for textiles with a water component: A pre-test will be done to 

verify that loading of the commercial dispersion without the UV stabilizer on to the textile 

surface is sufficiently high and that the test system performs properly. Irradiation of coated 

fabric would occur in a closed system using a reverse-phase cartridge for trapping the 

analytes. The starting material residuals will be characterized and the analytes to be 

quantified will be: 

Analyte CAS Registry Number 

[ [ 

] [ 

[ [ 

EPA SANITIZED Page 50 of 72
- 10 - 

4) Aerobic and Anaerobic Transformation in Soil (OECD 307): The Company is 

prohibited from manufacturing or importing the PMN substance beyond 3 years after 

commencement of non-exempt commercial manufacture, unless the Company conducts the 

Aerobic component of the Transformation in Soil (OECD 307) study on the PMN 

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

conditions specified in this Testing section. The Company is prohibited from 

manufacturing or importing the PMN substance beyond 6 years after commencement of 

non-exempt commercial manufacture, unless the Company conducts the Anaerobic 

component of the Transformation in Soil (OECD 307) study on the PMN substance and 

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

this Testing section. 

The analytes will be: 

Analyte CAS Registry Number 

[ [ 

[ [

[

[ ] [

[ [

[ [ 

[

For these four degradation studies, full kinetic studies will be conducted regardless of screening 

tests results. 

(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 (with an additional sanitized copy, if confidential business information is 

EPA SANITIZED Page 51 of 72
- 11 - 

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 production volume or time limit. The final report and 

data must be submitted as a support document for the PMN, using the procedures set out in 40 

CFR 720.40. 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 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 volume or time 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. 

EPA SANITIZED Page 52 of 72
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(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 volume or time limit. 

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

applicable production volume or time 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 volume or time limits 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 volume or time limit and shall submit the report and data 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 

EPA SANITIZED Page 53 of 72
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prevented, development of scientifically valid data under the conditions specified in paragraphs 

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

substance beyond the applicable production volume or time 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 volume or time 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 volume or time limits, 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 volume or time limit and shall 

submit the report and data 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 volume or time limit. 

(j) Unreasonable Risk.

EPA SANITIZED Page 54 of 72
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(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: 

(A) 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 

(B) 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 

EPA SANITIZED Page 55 of 72
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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. 

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. 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 the PMN substance in either the Federal Register or the 

Code of Federal Regulations. 

 

USE

EPA SANITIZED Page 56 of 72
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The Company shall not use the PMN substance in consumer products with spray applications. 

DISTRIBUTION

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. 

RISK NOTIFICATION

(a) If as a result of the test data required under the terms of this Order, the Company becomes 

aware that the PMN substance may present a risk of injury to human health or the environment (or 

is so notified by EPA), the Company must incorporate this new information, and any information 

on methods for protecting against such risk, into a Material Safety Data Sheet ("MSDS") for the 

PMN substance, as described in 40 CFR section 721.72(c), within 90 days 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 an MSDS before the PMN substance is reintroduced into the workplace. 

(b) The Company must ensure that persons who will receive the PMN substance from the 

Company, or who have received the PMN substance from the Company within 5 years from the 

EPA SANITIZED Page 57 of 72
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date the Company becomes aware of the new information described in paragraph (a) of this 

section, are provided an MSDS containing the information required under paragraph (a) within 90 

days from the time the Company becomes aware of the new information. 

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: 

 (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 only exemption in Section I, Paragraph (b)(1) 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)(2) 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 (3) and (4) below, 

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

EPA SANITIZED Page 58 of 72
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 (2) Records documenting compliance with the Chemical Synthesis and Composition, 

section of this Order; 

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

and the corresponding dates of manufacture and import; 

 (4) 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; 

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

use; 

(6) Records documenting compliance with any applicable manufacturing, processing, use, 

and distribution restrictions in the Manufacturing, Use, and Distribution sections of this Order; 

(7) Copies of MSDSs required by the Risk Notification section of this Order; 

(8) Copies of any Transfer documents and notices required by the Successor Liability 

section of this Order, if applicable; and, 

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

substance is manufactured, imported, processed, or used. 

(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities 

of the Company, 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 

EPA SANITIZED Page 59 of 72
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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: 

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

subsequent 12 months; 

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

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

(3) 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; 

(4) 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 that are 

collected during the manufacture or processing of the PMN substance; 

(5) Records required by the Recordkeeping section of this Order; and/or, 

EPA SANITIZED Page 60 of 72
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(6) 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 by 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 

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 

EPA SANITIZED Page 61 of 72
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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) and 40 CFR 720.3(z). 

(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 

EPA SANITIZED Page 62 of 72
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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: 

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. 

EPA SANITIZED Page 63 of 72
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(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 

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 human 

health or environmental effects of, or human exposure to 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. 

EPA SANITIZED Page 64 of 72
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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 65 of 72
EPA SANITIZED Page 66 of 72
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.

 “Final Formulation of the PMN substances” means the formulated dispersion of the PMN 

substances in the form in which it is sold to customers outside the Company or transferred to a 

different business unit within the Company. The term does not include intermediate dilutions of 

EPA SANITIZED Page 67 of 72
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the PMN substances that are intended only for use within the Company for further dilution prior to 

sale. 

“Identity” means any chemical or common name used to identify a chemical substance or a 

mixture containing that substance. 

 “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. 

 “Initially Isolated Formulations containing the PMN substances” means a common 

intermediate PMN formulation, as it exists when first produced and isolated after the polymer 

manufacturing process, that can be further processed or repackaged at the direction of the 

Company to result ultimately in one or more final formulations of the PMN substances. 

“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 

EPA SANITIZED Page 68 of 72
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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 

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.

EPA SANITIZED Page 69 of 72
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.

EPA SANITIZED Page 70 of 72
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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 

EPA SANITIZED Page 71 of 72
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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 

EPA SANITIZED Page 72 of 72