Support Documents for 

Significant New Use Rule (SNUR) on 

Premanufacture Notice (PMN) 

P-11-646 

EPA Docket EPA-HQ-OPPT-2012-0450 

EPA SANITIZED Page 1 of 69
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-646 

A-002 Initial Review Engineering Report for 

 PMN P-11-646 

A-003 Initial Review Exposure Report for 

 PMN P-11-646 

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

Determinations Supporting Consent Order for 

PMN P-11-646

EPA SANITIZED Page 2 of 69
A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-646 

EPA SANITIZED Page 3 of 69
SAT Report

PMN Number: P-11-0646

SAT Date: 9/30/2011

Print Date: 5/2/2012

Related cases:

Health related cases: 

Ecotox related cases: 

Concern levels:

Type of Concern: Health Eco Comments

Level of Concern: 1-2 1 Health: PMN ; Eco: intact material

2 3 Health: ; Eco: high concern for toxicity of incomplete incinerat

products to terrestrial organisms

 Persistence Bioaccum Toxicity Comments

3 1 1 PMN

3 2 2 Incin Pdt

Exposure Based Review:

Health:

Ecotox: No

Routes of exposure: Health: Inhalation Drinking water and inhalation for 

ncomplete incineration product

Ecotox: No releases to water

Fate: ;

Keywords:

 Keywords: PMN: LUNG OVERLOAD; LUNG

INCIN PRDT: LIVER; BLOOD; MALE REPRO; IMMUNOTOX; ONCO; AQUATOX

Summary of Assessment:

 Fate:

Fate Summary: P-11-0646

FATE: 

Solid 

S = Negl.

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

BP > 400 C (E)

H < 1.00E-8 (E)

EPA SANITIZED Page 4 of 69
POTW removal (%) = 90 via sorption

Time for complete ultimate aerobic biodeg > mo

Sorption to soils/sediments = v.strong

PBT Potential: PMN P3B1; Incin Pdt P3B2

*CEB FATE: Migration to ground water = negl

 Health:

 Health Summary: Absorption is nil all routes (pchem). Concern for lung 

toxicity if inhaled based on lung overload for high molecular weight polymers and potential 

waterproofing of the lungs for the PMN substance.

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

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 

 Test Data: (-) Salmonella with and without activation; (-) E. coli 

with and without activation

 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 nonionic polymers; SAR 

chemical class = 

 solid (P); S < 0.001 mg/L at 20 °C or negligible (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;

high concern for the incineration products

EPA SANITIZED Page 5 of 69
Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

*

SARs nonionic polymers

SAR Class polymer-nonionicEcotox Category 

Ecotox Factors Comments: 

 SAT Chair: L Keifer 564-8916

EPA SANITIZED Page 6 of 69
A-002 

Initial Review Engineering Report 

 for PMN P-11-646 

EPA SANITIZED Page 7 of 69
INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0646

Focus Ready Draft 10/13/2011

ENGINEER: Hall \ JD

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES: 

 

CRSS :

EPA SANITIZED Page 8 of 69
Consumer Use: 

SAT (concerns) (09/30/2011):

Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: Analog: 

Migration to groundwater: Negligible

PBT rating: P3B2T2 PMN: Health 1-2, Eco 1, P3B1T1 //

 Health 2, Eco 3

, P3B2T2.

Health: 2 Inhalation, Drinking water and inhalation for

Eco: 3 No releases to Water

OCCUPATIONAL EXPOSURE RATING: 1A

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

EPA SANITIZED Page 9 of 69
EXPOSURE-BASED REVIEW: 

INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0646

Use 

Number of Sites/ Location: 1

unknown site(s)

Days/yr: 250

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below

may coincide with daily releases from the other sources

to the same medium.

Water

Low End of Range: 6.0E-1 kg/site-day over 250 days/yr from

1 site

High End of Range: 1.7E+1 kg/site-day over 250 days/yr

from 1 site

Water or Incineration or Landfill

High End: 1.2E+0 kg/site-day over 240 days/yr from 1 site

or 3.0E+2 kg/yr

EPA SANITIZED Page 10 of 69
Water or Incineration or Landfill

Conservative: 4.0E-1 kg/site-day over 250 days/yr from 1

site

or 10.0E+1 kg/yr

RELEASE TOTAL

4.6E+3 kg/yr - all sites

OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 6

Basis: 

Inhalation:

Negligible (VP < 0.001 torr). 

Dermal:

Exposure to Liquid at 20.00% concentration

Low End of Range: 1.2E+2 mg/day over 250 days/yr

High End of Range: 3.5E+2 mg/day over 250 days/yr

Number of workers (all sites) with dermal exposure: 6

Basis:

EPA SANITIZED Page 11 of 69
MEMORANDUM of CBI TELEPHONE CONVERSATION

CALL BY: EV

Organization: ERG for EPA

CALL TO: 

Organization: 

Date: 03/21/2011

Time: 1:20 PM

Phone: 

PMN: 11-0646

EPA SANITIZED Page 12 of 69
A-003 

Initial Review Exposure Report 

 for PMN P-11-646 

EPA SANITIZED Page 13 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0646 Reviewer: Flessner/SS 

 

 

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 

1.11E-02 --- --- --- 2.27E+02 --- --- 1.99E-03 --- --- --- 

USE: PDM1 --- --- --- --- 2.27E+02 --- --- --- --- --- 

USE: PDM2 --- --- --- --- 2.13E+02 --- --- --- --- --- 

USE: Max LADD --- 1.85E-04 --- --- --- --- --- --- 1.05E-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: 

EPA SANITIZED Page 14 of 69
10/12/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0646 Assessor: Flessner/SS 

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: 

EPA SANITIZED Page 15 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0646 

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 10.54 24.73 39.85 48.26 

ALL 10 34.81 132.95 227.38 271.93 

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 5.40E-05 1.79E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.77E-03 9.16E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 2.07E-03 1.11E-02 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 16 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0646 

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): 1.42 μg/m3

Max 24 Hour Average Air Concentration (Stack): 10.80 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 1.04E-04 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 5.68E-04 N/A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 1.99E-03 N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

EPA SANITIZED Page 17 of 69
10/12/11 page of 

 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

N/A 

Stack Gas 

Temperature: 

293.00 K 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

EPA SANITIZED Page 18 of 69
10/12/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0646 Assessor: Flessner/SS 

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: 

EPA SANITIZED Page 19 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0646 

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 10.54 24.73 39.85 48.26 

ALL 10 34.81 132.95 227.38 271.93 

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 5.40E-05 1.79E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.77E-03 9.16E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 2.07E-03 1.11E-02 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 20 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0646 

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 

EPA SANITIZED Page 21 of 69
10/12/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0646 Assessor: Flessner/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: USE: 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: 

EPA SANITIZED Page 22 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0646 

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

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

PDM2 

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 9.86 23.14 37.28 45.15 

ALL 10 32.57 124.37 212.71 254.39 

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 5.27E-05 1.74E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.70E-03 8.92E-03 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.93E-03 1.04E-02 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 23 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0646 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 3 RELEASE ACTIVITY: USE: PDM2 

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 

EPA SANITIZED Page 24 of 69
10/12/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0646 Assessor: Flessner/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:4 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: 

EPA SANITIZED Page 25 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0646 

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

SCENARIO #: 4 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 5.61E-05 1.85E-04 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.88E-03 9.51E-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: 

EPA SANITIZED Page 26 of 69
10/12/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0646 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 4 RELEASE ACTIVITY:USE: Max LADD 

RELEASE DESCRIPTION: 

METHOD OF CALCULATION: Screen3 

EXPOSED POPULATION: Adult 

Number of Sites: 

Per Site Fugitive Release: 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): 1.43 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) 1.05E-04 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 5.72E-04 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: 

EPA SANITIZED Page 27 of 69
10/12/11 page of 

 Stack Parameter Data Fugitive Parameter Data 

Stack Height 10.00 m Release Height: N/A 

Inside Stack 

Diameter: 

0.10 m Length of Release 

Opening: 

N/A 

Stack Gas Exit 

Velocity: 

0.10 m/sec Width of Release 

Opening: 

N/A 

Stack Gas 

Temperature: 

293.00 K 

 

 Meteorological and Terrain Information: 

Surrounding Land Use: Rural 

Terrain Height: 0.00 m 

Distance to Residence of Interest: 100.00 m 

Meteorological Class: Full 

Stability Class: NA 

Wind Speed: NA 

 

 Downwash Information: 

Facility Length: NA m 

Facility Width: NA m 

Facility Height: NA m 

EPA SANITIZED Page 28 of 69
A-004 

TSCA Section 5(e) Consent Order 

 and Determinations Supporting Consent Order 

 for PMN P-11-646

EPA SANITIZED Page 29 of 69
1.JNITED STATES EN~vIRONIY[ENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Premanufactnre Notice Number: 

) 

) 

) 

) 

) 

[ ] ) P-1l-646 

) 

) 

) 

) 

) 

Consent Order and Determinations Supporting Consent Order 

EPA SANITIZED Page 30 of 69
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Tenns oftbe Order 

III. Contents ofPMN 

N. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Infonnation Required to Evaluate Human Healtb and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation of Infonnation 

III. Recordkeeping 

N. Requests for Pre-Inspection Infonnation 

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 31 of 69
111 

I. INTRODUCTION 

Under the authority of § 5(e) of the Toxic Substances Control Act ("TSCA") (IS U.S.C. 

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

Order, regarding premanufacture notice ("PMN") [

]; P-11-646, submitted 

by [ ] ("the Company"), to take effect upon expiration of the PMN 

review period. The Company submitted the PMN to EPA pursuantto § 5(a)(l) ofTSCA and 40 

CFR Part 720. 

Under § IS ofTSCA, 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 § 50fTSCA, 

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 environmental fate and physical/chemical testing on [

before March 31, 2015. 

(b) maintain certain records. 

EPA SANITIZED Page 32 of 69
IV 

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 clainIed 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 information contained within the brackets. 

Confidential Business Information ClainIs (Bracketed in the Preamble and Order): company 

identity, specific chemical identity, production volume, manufacturing process, processing, and 

use information, and other information 

Chemical Identity: 

Specific: [

] ; 

Generic: Perfluoroalkylethyl methacrylate copolymer 

Use: 

Specific: [ ] 

Generic: Fabric treatment 

Maximum 12-Morith Production Volume: [ ] kgs 

EPA SANITIZED Page 33 of 69
v 

Test Data Submitted with PMNs (many acronyms are subsequently explained in section N 

below): 

1) "Test of Schematic Flow for Safety Evaluation of Polymers" (chemical and physical 

properties), plus tables and figures; and 2) Reverse Mutation Test Using Microorganisms. 

Previously submitted relevant testing: 

Submitted in 2004: 

1) Bioconcentration study of [ in carp; 2) Biodegradation study of [ ] by 

microorganisms; C6-2AL: 3) Acute Oral Toxicity in the rat; C6-2AL: and 4) Reverse Mutation 

Study. 

Submitted in 2005: 

1) Perfluorohexanoic acid (PFHxA, PFHA) and the C6-2 Alcohol Combined Repeated Dose 

Toxicity Study with Reproduction/Developmental Screening test (OECD 422); 2) PFHxA: 

Pharmacokinetic (in Blood) and Excretion Study in Cynomolgus Monkeys ofPerfluorohexanoic 

acid and Nonafiuoro-l-butanesulfonic acid and later another study in 3) rats; 4) PFHA: Acute 

Toxicity to Daphnia magna; 5) PFHA: Acute Toxicity to Rainbow trout; 6) PFHA: Algal 

inhibition test; 7) Martin J., Mabury S. et ai, Bioconcentration and Tissue Distribution 

Perfiuorinated Acids in Rainbow Trout, Env. Toxicology and Chemistry voL 22, no. I pp.196-

204. C6-2 alcohol: 8) C6-2AL: Acute Toxicity to Daphnia Magna; 9) Acute Toxicity to 

Rainbow Trout; 10) Algal Inhibition Test; and 11) Bioconcentration Study of C6-2 Alcohol in 

Carp. 

EPA SANITIZED Page 34 of 69
V1 

Submitted in 2006: 

1) A 90-day Repeated Dose Oral (gavage) Toxicity Study ofPer:!luorohexanoic Acid (PFHxA) 

in Rats (with Functional Observational Battery and Motor Activity Determinations) 

Submitted in 2011: 

1) Chronic Toxicity, Carcinogenicity on PFHxA in rats; 2) Avian Reproduction study on 

PFHxA 

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 and Fate Summary: EPA has concerns for potential fluorinated 

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

the PMN substance under some conditions ofuse-- particularly non-industrial, commercial, or 

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

compounds. 

EPA has concerns for the potential degradation of the PMN substance and for the 

subsequent perfluorinated products. The PMN substance is a derivative of perfluorohexanoic 

acid, PFHxA or PFHA. Based on information submitted to EPA during the PMN review period, 

this substance has little or no higher chain length perfluorinated components or impurities due to 

its manufacturing process. There appears to be no C8 or higher homolog perfluorinated 

impurities and the C6 perfluorinated monomers/feedstock residuals are minimized and quantified 

EPA SANITIZED Page 35 of 69
VII 

based on previously submitted Certificates of Analysis and other information. In addition, the 

PMN substance is made in a facility that is dedicated to the production of substances with C6 

chemistry. 

EPA is concerned that perfluorinated products of the PMN substance may be released to 

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

has preliminary evidence, including data on similar PMN substances, that suggests that, under 

some conditions, the PMN substance could degrade in the environment. EPA has concerns that 

these degradation products will persist in the environment, could bioaccumulate or biomagnifY, 

and could be toxic (PBT) to people, wild mammals, and birds based on data on analog chemicals, 

including perfluorooctanoic acid (PFOA) and perfluorohexane sulfonate (PFHxS). The 

presumed perfluorinated degradants for the PMN substance includes perfluorohexanoic acid, 

PFHxA. There is limited toxicological data in animals on PFHxA or precursors, which is 

sunrmarized below·: 

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. 

Cancer may also be of concern. These factors, taken together, raise concerns for potential 

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

the docket OPPT-2003-0013. Additional information about PFOA, PFHxS, and other 

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

EPA SANITIZED Page 36 of 69
Vlll 

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 requesttooppt.ncic@epa.gov. 

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

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

PMN s. A pharmacokinetics study on PFHxA and for comparison perfluorobutane sulfonate 

(PFBS) in the Cynomolgus Monkey was submitted previously. This study indicates that the 

serum half-life ofPFHxA in these monkeys is less than 24 hours, whereas the half-life ofPFOA 

in monkeys is 20.9 days in female monkeys, 32.6 days in male monkeys, and 3.8 years in 

humans. The Company also conducted a pharmacokinetics study on PFHxA in rats that showed 

a serum half-life of one hour or less. These data support the assessment of reduced 

bioaccumulation ofPFHxA relative to PFOA. 

In 2005, the Company conducted a Combined Repeated-Dose Toxicity Study with 

ReproductionlDevelopmental Screening Test, (OECD 422) in rats for PFHxA and the C6-2 

Alcohol. The EPA review of these subchronic and reproductive data on PFHxA and the C6 

alcohol concluded that for PFHxA no reproductive effects were seen at any dose. Dose levels 

were 50, 150, and 450/300 mglkglday (450 was reduced to 300 in study on day 4 because of 

toxicity). However, systemic effects-primarily liver effects-- were seen. EPA review places the 

No-Adverse Effect Level or NOAEL for PFHxA at 50 mglkglday. For the C6 alcohol, the doses 

were 25, 75, and 225 mglkglday. For systemic effects, there was no NOAEL achieved with the 

Lowest-Adverse Effect Level (LOAEL) at 25 mglkglday. For reproductive or developmental 

effects, the NOAEL is 75 mglkglday and the LOAEL is 225 mglkglday. 

EPA SANITIZED Page 37 of 69
IX 

In 2006, the Company submitted a 90-day oral repeated dose toxicity study (OECD 408). 

Dose levels for this study were 0 (vehicle control), 10, 50, or 200 mg/kg/day and were based on 

the previous Combined Study (OECD 422). EPA review sets the LOEL or LOAEL at 10 

mg/kg/day based on the body weight gain being lower in all treated groups of males. There was 

treatment-related toxicity in the liver and the red blood cell system (anemia) in males at 200 

mg/kg/day. There was also increased peroxisomal beta oxidation activity at this dose level. 

Hepaptotoxicity and peroxisomal beta oxidation activity have also been seen in studies on PFOA. 

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

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

compounds, is not a rare tumor, and may be incidental. Abnormal histopathology was observed 

in the testes (2 males) and epididymides (1 male) at 200 mg/kg/day and is a sign of concern for 

male reproductive toxicity. Further testing should investigate male reproductive effects. From 

this study, the potential for immunotoxic effects is low. There have been some studies showing 

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

corroborative testing now being conducted by EPA, 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. 

Two other 90-day studies have been submitted on PFHxA. EPA review of those studies 

concluded that there were effects at the higher doses. For one study, there were blood and liver 

effects at the highest dose. In the other study there were effects were seen at the 2 higher doses. 

In the reproductive component of one ofthe studies, there were some effects at the highest dose 

(500 mg/kg/day). These two studies had comparable dose levels. 

EPA SANITIZED Page 38 of 69
x 

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

salt of PFHxA was submitted to the Agency. In this study, pregnant mice were administer the 

test substance via gavage during gestation days 6-18. The NOAEL for maternal toxicity was 175 

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

mg/kglday on the 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 a pup with lenticular 

opacity. The NOAEL for developmental toxicity is 35 mg/kglday. 

A 2-year chronic toxicity/carcinogenicity study was conducted under this Consent Order 

and submitted to EPA in 2011. EPA is currently reviewing additional data concemingthis study. 

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

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

persistence ofPFHxA; (2) potential intermediate fate products; and (3) the possibility or 

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

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

environmental degradants and the fate, and physical/chemical properties ofPFHxA-derived 

polymers in the environment. 

EPA also believed that additional reproductive and long-term toxicological testing on 

PFHxA in animals was warranted. To this end, the Company conducted a modified I-generation 

reproductive test in rats (OECD 421, modified); and a two-year chronic toxicity/carcinogenicity 

test in rats (OECD 453). The modifications for the reproductive test include: (I) 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) 

EPA SANITIZED Page 39 of 69
Xl 

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 matuation should be 

recorded (i.e. vaginal opening and preputial separation). An avian reproduction test (OECD 206) 

has also been conducted by the Company .. In addition, comparative data, especially on the 

pharmacokinetics of PFHxA and other perfluorinated substances will be developed by testing of 

the National Toxicology Program (NTP) in the so-called Perfluoro Class Study. 

Enviromnental Effects Summary: EP A expects the PMN substance to be highly persistent. 

No ecotoxicological concerns were raised for the PMN polymer itself based on data on other 

non-ionic polymers. However, there is high concern for possible enviromnental effects from the 

potential persistent degradation product PFHxA. As stated previously, the analog PFOA is 

persistent in the enviromnent and has a long bioretention time in various species. It has been 

detected in a number of species of wildlife, including marine mammals. It is toxic to mammalian 

and other species. The presence in the enviromnent and toxicological properties ofPFOA 

continue to be investigated. Some limited acute ecotoxicological effects data exist on PFHxA in 

fish, daphnia, and algae. EPA believes development of additional data is warranted and the 

Company has conducted an Avian Reproduction Test (OECD 206) on PFHxA. 

EPA SANITIZED Page 40 of 69
XlI 

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 biodegradation tests have 

been conducted on some related polymers. EPA has determined that the structurally analogous 

polymer degrades. 

The PMN substance will be imported and used as a [

]. This new chemical is intended to be used in [ l] settings 

only. 

In the processing of the PMN substance for use in [

], it is estimated that the substance could be used at unknown customer site for [ ] 

days/per year. ThePMN substance will be imported as a liquid at [ ] % concentration. The 

liquid will be mixed with other additives to a [ % concentration during use. Release to 

. water from equipment cleaning and container residue is possible, although the media of release is 

uncertain. The waste could be incinerated or landfilled. If incinerated, some releases of the 

perfluoro component are expected. 

An estimate of[ ] workers could be exposed over [ ] days annually. Inhalation is 

expected to be negligible. Dermal exposure is possible. From use on textiles, it is expected that 

there is a possibility of release of the perfluoro component from the textile materials. If the 

substance is used on [

]. Exposure could also occur during [

. The substance is intended to be applied at the factory for [

EPA SANITIZED Page 41 of 69
X11l 

1 uses and at the dye works or textile finishers to treat cloth. EPA expects that use on 

textiles could result in the environmental release of degradants of concern from low temperature 

incineration or burning. 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

A. EPA is unable to determine the potential for human health and environmental effects from 

exposure to the PMN substance and potential degradation products. EPA therefore concludes, 

pursuant to § 5(e)(I)(A)(i) ofTSCA, 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) (I )(A)(ii)(I) ofTSCA, 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)(l )(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. 

EPA SANITIZED Page 42 of 69
XIV 

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. 

Pending Testing. The Order does not require submission of the following information at 

any specified time or production volume. However, the Order'srestrictions 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 the 

following or other relevant information. 

1. Because some concerns for the PMN substanceaIe based on analogy between PFHxA 

and PFOA, and because PFHxA is a potential ultimate degradation product of the PMN 

substance, the following additional information on PFHxA would be necessaty to evaluate the 

human health and environmental effects which may be caused by the PMN substance: a modified 

I-generation reproduction study in rats (OECD Guideline 421 modified as stated eaIlier in the 

Preamble); a combined chronic toxicity/caIcinogenicity test (OECD Guideline 453); and an avian 

reproduction test (OECD Guideline 206). The Company has agreed to perform this testing. For 

the new animal toxicity testing, the Company has agreed to submit protocols for EPA review 

prior to the initiation of testing. Due to the limited water solubility of some of the substance and 

consequent analytical difficulties, some modification of the protocols may be necessaty. These 

modifications will be agreed upon between EPA and the Company. 

EPA SANITIZED Page 43 of 69
xv 

2. Information on inhalation toxicology if the substance was to be sprayed by commercial 

or consumer applicants. This could include a 90-day Inhalation study in rats with a 60-day 

holding period (OPPTS 870.3465 or OEeD 413) or other relevant information. 

EPA SANITIZED Page 44 of 69
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

TSCA CONFIOENTIA~ 

BUSiNESS INFORMA'1"IOi\\ 

DOES NOT CONTAIN NATIOI\\(',i, SECURITY INFORMATION (e,o, 'i2u;·,,· 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

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

distribution in commerce, use and disposal ofthe chemical substance: [

]; P-I1-646; (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 of the PMN substance is exempt from the requirements ofthis 

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. 

(I) 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, 

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

Recycled/Recyclable' Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 

EPA SANITIZED Page 45 of 69
2 

processing or distribution in commerce of the PMN substance solely for export in accordance 

with TSCA §12(a) and (b), 40 CFR nO.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 volUlne 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 

nO.3(cc), and 40 CFR n0.36. 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 n0.30(i) 

and TSCA §5(i). 

(3) 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 nO.3(d) and in compliance with 40 CFR nO.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 

nO.30(h), with no commercial purpose separate from the substance, mixture, or article of which 

it is a part. 

EPA SANITIZED Page 46 of 69
3 

(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 CPR 720.3 ( c) and in compliance with 

40 CPR 720.22(b)(l). 

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

Exemption ("TME") under TSCA §5(h)(1) and 40 CPR 720.38 or a Low Volume Exemption 

("L VE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)( 4) and 40 

CPR 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 human health and environmental effects of the substances, and the 

completion of EPA's review of, and regulatory action based on, that information, in accordance 

with the conditions described in this Order. 

MANUFACTURING 

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

import of the PMN substance by any other person. 

EPA SANITIZED Page 47 of 69
4 

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

promulgation of a final significant new use rule (SNUR) governing the PMN substance under 

section 5(a)(2) ofTSCA 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 affinned. 

(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. 

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) ofTSCA, the PMN substance is subject to the export 

notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice 

shall contain, in the fonn 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. 

TESTING 

(a) Section See) Reporting. Reports ofinfonnation on the PMN substance which reasonably 

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

EPA SANITIZED Page 48 of 69
5 

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/opptitsca8e. 

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

Assistance & Media Program Division (2227 A), Office of Enforcement and Compliance 

Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., 

Washington, D.C. 20460, of the following information within 10 days of scheduling any study 

. required to be performed pursuant to this Order, or within 15 days after the effective date of this 

Order, whichever is later: 

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

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

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

EPA may contact regarding the study; and 

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

the substance is subject to this Consent Order. 

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

performed pursuant to this Order must be conducted according to TSCA Good Laboratory 

Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the 

relevant scientific community at the time the study is initiated. Before starting to conduct any 

study, the Company must obtain review of test protocols from EPA by submitting written 

EPA SANITIZED Page 49 of 69
6 

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

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

test protocols, but are not themselves acceptable protocols. EPA review of a test protocol does 

not mean pre-acceptance oftest results. 

(d) Triggered Testing Requirements. (1) The Company is prohibited from manufacturing or 

importing the PMN substance, P-11-646, beyond March 31, 2015 ("the production limit"), unless 

the Company conducts the following studies on the PMN substance, [

] 

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

Testing section of the aforementioned Order. 

Modified Semi-Continuous 

Activated Sludge (SCAS) with 

Analysis for degradation products 

UV Visible Light absorption 

Guideline 

OPPTS Test Guideline 

835.5045 or OECD 302A 

OPPTS Test Guideline 

830.7050, OECD 101 

Direct photolysis, if wavelengths OPPTS Test Guideline 

Greater than 290nm are absorbed in 835.2210 

the previous test 

Photolysis on soil--

Phototransformation of Chemicals 

on Soil Surfaces-2 soils 

Indirect photolysis screening test 

(Sunlight photolysis in waters 

Containing dissolved organic carbon) 

Draft OECD guideline 

Jan. 2002 

OPPTS Test 

Guideline 835.5270 

EPA SANITIZED Page 50 of 69
7 

Hydrolysis as a function of pH 

Aerobic and Anaerobic Transformation 

In Aquatic Sediment Systems 

Anaerobic Biodegradability of Organic 

Compounds in Digested Sludge 

OECD 111 

OECD 308 

OECD 311 

(2) Chemical composition of the substance to be tested must be fully characterized. For 

polymers, characterization includes all information required on pages 5 and 6 of the PMN form, 

except that data on residuals are only required for fluorinated substances. Special 

characterization for unique properties of interest to EPA, which may include information claimed 

as Confidential Business Information (CBI), must be confirmed either through experimental 

determination or through the Company certification that the express conditions used to 

manufacture the PMN substance are comparable to cited literature references (and they must be 

cited), that produce the unique properties of interest. Although EPA understands that complete 

mass balance may not be achievable for these substances, the Company shall attempt mass 

balance to the greatest extent practicable, and residuals and impurities analogous to those known 

to occur in the C8 series must be investigated. EPA prefers that the Company test the 

commercial substance. 

(3) The Company must test for the following analytes in the Biodegradation tests (OECD 

308, OECD 311, and OPPTS 835.5045 or OECD 302A): C6-2FMA (monomer): CAS RN: 

2144-53-8; 6-2 carboxylic acid: CAS RN: 53826-12-3; 6-2 unsaturated carboxylic acid: CAS 

RN: 161094-75-3; 6-2 alcohol: CAS RN: 647-42-7; C6 acid (PFHxA): CAS RN: 307-24-4; 5-2 

sec.-alcohol: No CAS number; and 5-3 acid: CAS RN: 914637-49-3. 

Because the environmental fate pathway for photolysis and hydrolysis may be different 

than biodegradation, the Company must test for the following analytes: Hydrolysis test-6:2 

EPA SANITIZED Page 51 of 69
8 

telomer alcohol, CAS RN: 647-42-7; Photolysis tests-identifY the major fluorinated fragments 

and volatiles including 6:2 telomer alcohol, CAS RN: 647-42-7; 6:2 carboxylic acid, CAS RN: 

53826-12-3, tridecafluoro-l-octene (CF3(CF2)5CH=CH2), CAS RN:25217-91-2, and 

tridecafluoroheptanoic acid (CF3(CF2)5C02H), CAS RN: 375-85-9. 

(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 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 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, 

EPA SANITIZED Page 52 of 69
9 

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)(l) 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. 

(I) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt ofa 

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

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

import of the PMN substance beyond the applicable production limit. 

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

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

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

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

and (e)(l) 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. 

EPA SANITIZED Page 53 of 69
10 

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

described in subparagraph (h)(l), 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. 

(I) 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 nnder 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 offrrst becoming aware of such 

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

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

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

Company's report. EPA's written response may either: 

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

beyond the applicable production limit, or 

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

compliance with paragraphs (b), (c), and (e)(l) 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 

EPA SANITIZED Page 54 of 69
11 

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. 

G) Umeasonabli: 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 andlor 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 ofthe 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 andlor 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 tenns 

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 

EPA SANITIZED Page 55 of 69
12 

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 

IV. of this Consent Order. 

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"), as described in 40 CFR section 72l.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 

date the Company becomes aware of the new information described in paragraph (a) of this 

EPA SANITIZED Page 56 of 69
13 

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

90 days from the time the Company becomes aware of the new infonnation. 

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 ofTSCA: 

(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 )(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) and12(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 57 of 69
14 

(2) Records documenting the manufactnre and importation volume of the PMN 

substance and the corresponding dates of manufactnre and import; 

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

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

Company directly sells or transfers thePMN substance, the date of each sale or transfer, and the 

quantity of the substance sold or transferred on such date; 

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

use; 

(5) Copies of material safety data sheets required by the Risk Notification section of this 

Order; 

(6) Records documenting compliance with the Manufacturing and Distribution sections; 

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

section of this Order, if applicable; and 

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

substance are manufactured, imported, processed, or used. 

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

of the Company and its Contract Manufactnrer, 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 

EPA SANITIZED Page 58 of 69
15 

Office of Management and Budget ("OMB"), and EPA so informs the Company. The 

"collection of information" required in this TSCA §5(e) Consent Orders has been approved 

under currently valid OMB Control Number 2070-0012. 

IV. REOUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA 

may ocassionally 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 may 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 pmpose. 

EPA SANITIZED Page 59 of 69
16 

(b) Company's Response. The Company shall respond to such requests within a reasonable 

period of time, but in no event later than 30 days after receiving EPA's request. When requested 

in writing by EPA, the Company's response shall be in writing. To the extent the information is 

known to or reasonably ascertainable to the Company at the time of the request, the Company's 

response shall demonstrate a good faith effort to provide reasonably accurate and detailed 

answers to all of EPA's requests. 

(c) Confidential Business Information. Any Confidential Business Information (CBl) 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 new PMNs to EPA and comply fully with Section 5(a)(I) ofTSCA and 40 CFR 

part 720 before commencing manufacture or import of the PMN substance. 

EPA SANITIZED Page 60 of 69
17 

(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 new PMN s 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(3). 

(2) "Transfer Document" means the legal instrmnent(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· 

EPA SANITIZED Page 61 of 69
18 

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: 

u.s. Enviromnental Protection Agency, NewChemicals 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 and time 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) Liabilitv. 

(1) The Company shall be liable for compliance with the requirements of this Order until 

the effective date and time 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 and time 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. Ifparagraph (d) of the Testing section 

of this Consent Order requires the Company to submit test data to EPA at a specified production 

EPA SANITIZED Page 62 of 69
19 

volume ("test trigger"), the aggregate volume of the PMN substance manufactured and imported 

by the Company up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new information on the health 

effects of, or human exposure to, the PMN substance, to modif'y 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 substal1ce. 

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 63 of 69
20 

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry of this Order, the Company waives its rights to file 

objections to this Order pursuant to section 5(e)(l)(C) ofTSCA, to receive service of this Order 

no later than 45 days before the end ofthe review period pursuant to section 5(e)(l)(B) ofTSCA, 

and to challenge the validity of this Order in any subsequent action. Consenting to the entry of 

this Order, and agreeing to be bound by its terms, do not constitute an admission by the Company 

as to, the facts or conclusions underlying the Agency's determinations in this proceeding. This 

waiver does not affect any other rights that the Company may have under TSCA. 

(b) CEl Brackets. By signing this Order, the Company represents that it has carefully reviewed 

this document and hereby agrees that all information herein that is claimed as confidential by the 

Company (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) 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. 

/l;l~' ,VlCVVc 

Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

:5 (z:s l~' zDate 

Company: [ ] 

EPA SANITIZED Page 64 of 69
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 of 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. 

"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. 

"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 labelled 

container. 

EPA SANITIZED Page 65 of 69
3 

"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 ofthe 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 

arr may occur. 

"Non-industrial use" means use other than at a facilitywhere chemical substances or 

mixtures are manufactured, imported, or processed. 

"PMN substance" means the chemical substance (see TSCA s. 3(2» described in the 

Premanufacture notice submitted by the Company relevant to this Order. 

"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 

confonnity 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-tenn 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. 

"Workplace" means an establishment at one geographic location containing one or more 

work areas. 

EPA SANITIZED Page 66 of 69
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

PMNNumber 

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 ofthe 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(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 ofTSCA 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 67 of 69
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

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 68 of 69
3 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone 

EPA SANITIZED Page 69 of 69