Support Documents for 

Significant New Use Rules (SNUR) on 

Premanufacture Notices (PMN) 

P-11-203 

EPA Docket EPA-HQ-OPPT-2012-0450 

EPA SANITIZED Page 1 of 68
Index 

A-001 Structure Activity Team (SAT) Report for 

 PMN P-11-203 

A-002 Initial Review Engineering Report for 

 PMN P-11-203 

A-003 Initial Review Exposure Report for 

 PMN P-11-203 

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

Determinations Supporting Consent Order for 

PMN P-11-203

EPA SANITIZED Page 2 of 68
A-001 

Structure Activity Team (SAT) Report 

 for PMN P-11-203 

EPA SANITIZED Page 3 of 68
SAT Report

PMN Number: P-11-0203

SAT Date: 2/18/2011

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 2 Health: PMN ; Eco: intact material; significant mitigation of toxicity expe

i.e., ~13x

2 3 Health: degradation/incineration product ; Eco: concern for toxicity of inc

incineration products to terrestrial organisms

 Persistence Bioaccum Toxicity Comments

3 1 1 PMN

3 2 2 Incin Pdt

Exposure Based Review:

Health: No

Ecotox: No

Routes of exposure: Health: Inhalation 

Ecotox: All releases to water

Fate: ;

Keywords:

 Keywords: LUNG, AQUATOX-A,C

Summary of Assessment:

 Fate:

Fate Summary: P-11-0203

FATE: 

Solid 

S = Disp.

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

BP > 400 C (E)

H < 1.00E-8 (E)

POTW removal (%) = 90-9 via sorption 

EPA SANITIZED Page 4 of 68
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 based on physical/chemical 

properties. There is concern for lung effects if respirable particles are inhaled through either 

lung overload based on the high molecular weight of 25,000 or through cationic binding with 

lung tissues and waterproofing of the lungs. Low moderate concern for the PMN material. 

For the potential environmental degradation/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 Moderate concern.

 Test Data: TOXICITY DATA from MSDS for polymer without salt:

negative in Salmonella and E coli (submitted with PMN for )

acute oral study in rats - no deaths or signs of toxicity at 2000 mg/kg (submitted with PMN for 

)

negative in the mouse local lymph node assay (apparently a supplemental submission to 

)

negative in chromosomal aberration test (apparently a supplemental submission to )

28-day oral study in rats - NOEL = 1000 mg/kg (apparently a supplemental submission to 

)

 Ecotox:

Test Organism Test 

Type

Test End 

Point

Predicted Measured Comments

fish 96-h LC50 5.5

daphnid 48-h LC50 43

green algal 96-h EC50 3.9

fish _ chronic value 0.31

daphnid _ chronic 

value

3.1

algal _ chronic 

value

1.1

Sewage Sludge 3-h EC50 _

Sewage Sludge _ Chronic 

Value

_

EPA SANITIZED Page 5 of 68
Ecotox Values Comments: Predictions are based on SARs for polycationic polymers with 

 SAR chemical class = 

; solid (P) with mp unk and S = dispersible (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;

mitigation of toxicity expected in the presence of 10 mg TOC/L, i.e., ~13 times;

high concern for the persistent aerobic degradation product

Factors Values Comments

Assessment Factor 10

Concentration of Concern 

(ppb)

400 with mitigation

SARs polycationic polymers

SAR Class polymer-cationic new chemicals category: polycationic 

polymers, but contains 

Ecotox Category 

Ecotox Factors Comments: 

 SAT Chair: Becky Jones

EPA SANITIZED Page 6 of 68
A-002 

Initial Review Engineering Report 

 for PMN P-11-203 

EPA SANITIZED Page 7 of 68
INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0203

Focus Ready Draft 2/28/2011

ENGINEER: Hall \ JD

PV (kg/yr): 

SUBMITTER: 

USE:

OTHER USES:

 

CRSS :

Consumer Use: 

SAT (concerns) (02/18/2011):

EPA SANITIZED Page 8 of 68
Related Cases and Related Cases and Misc SAT Info:

Ecotox Related Cases: 

 // Human Health Related Cases:

Migration to groundwater: Negligible

PBT rating: P3B2T2 PMN: Health 1-2; Eco 2 // :

Health 3; Eco 2 // PMN: P3B1T1 // P3B2T2

Health: 2 Inhalation

Eco: 3 Water (All releases to water with a CC = 400 with

migration)

OCCUPATIONAL EXPOSURE RATING: 0-1

NOTES & KEY ASSUMPTIONS:

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

POLLUTION PREVENTION CONSIDERATIONS:

P2 Claim: 

EXPOSURE-BASED REVIEW: 

EPA SANITIZED Page 9 of 68
INITIAL REVIEW ENGINEERING REPORT 

PMN: 11-0203

Processing/Use: 

Number of Sites/ Location: 10

unknown sites

Days/yr: 250

Basis:

Process Description: 

ENVIRONMENTAL RELEASES ESTIMATE SUMMARY

IRER Note: The daily releases listed for any source below

may coincide with daily releases from the other sources

to the same medium.

Water or Incineration or Landfill

High End: 8.1E-1 kg/site-day over 185 days/yr from 10

sites

or 1.5E+3 kg/yr

Water or Incineration or Landfill

Conservative: 2.0E-1 kg/site-day over 250 days/yr from 10

sites

or 5.0E+2 kg/yr

RELEASE TOTAL

2.0E+3 kg/yr - all sites

EPA SANITIZED Page 10 of 68
OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

Tot. # of workers exposed via assessed routes: 0

Basis:

Inhalation:

negligible (VP < 0.001 torr).

Dermal:

Dermal not required, per SAT.

EPA SANITIZED Page 11 of 68
A-003 

Initial Review Exposure Report 

 for PMN P-11-203 

EPA SANITIZED Page 12 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT (IRExR) 

 Chemical ID: P-11-0203 Reviewer: Wong/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 = 400 

PDM 

Days 

Exceede

d 

LADD ADR LADD ADR LADD 

Release 

activity(ies)2; 

exposure 

calculation(s)3 

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

PROC/USE: Max 

ADR: max acute eco 

1.09E-04 --- --- --- 2.10E+00 --- --- 1.25E-03 --- --- --- 

PROC/USE: PDM1 --- --- --- --- 2.10E+00 --- --- --- --- --- 

PROC/USE: PDM2 --- --- --- --- 4.20E-01 --- --- --- --- --- 

PROC/USE: Max 

LADD 

--- 2.79E-06 --- --- --- --- --- --- 5.43E-05 --- --- 

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) NA No 

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

Inhalation Dose (mg/kg/day) NA No 

Groundwater Dose (mg/kg/day) NA No 

Surface Water Release After Treatment (kg/yr) NA No 

Total Release After Treatment (kg/yr) NA No 

Consumer Use? No 

Fate test recommendations?: (default is NA)

EPA SANITIZED Page 13 of 68
2/25/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0203 Assessor: Wong/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:1 Number of Release Sites: 

 Release Activity: PROC/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 14 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0203 

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

SCENARIO #: 1 Number of Sites: RELEASE 

ACTIVITY:PROC/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 3.78E-02 9.48E-02 0.14 0.17 

ALL 10 0.66 1.31 2.10 2.36 

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 1.49E-07 2.61E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 7.67E-06 1.34E-04 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 7.92E-06 1.09E-04 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 15 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0203 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 1 RELEASE ACTIVITY:PROC/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): 0.69 μg/m3

Max 24 Hour Average Air Concentration (Stack): 6.80 μg/m3

ASSUMPTIONS 

Exposure Units 

Results 

(Stack) 

Results 

(Fugitive) ED 

(years) 

AT 

(years) 

BW 

(kg) 

Inh. Rate 

(m3/hr) 

Cancer 

LADDpot (mg/kg/day) 5.07E-05 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 2.76E-04 N/A 30.00 75.00 NA NA 

Acute 

ADRpot (mg/kg/day) 1.25E-03 N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

EPA SANITIZED Page 16 of 68
2/25/11 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 17 of 68
2/25/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0203 Assessor: Wong/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:2 Number of Release Sites: 

 Release Activity: PROC/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 18 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0203 

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

SCENARIO #: 2 Number of Sites: RELEASE 

ACTIVITY:PROC/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 3.78E-02 9.48E-02 0.14 0.17 

ALL 10 0.66 1.31 2.10 2.36 

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 1.49E-07 2.61E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 7.67E-06 1.34E-04 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 7.92E-06 1.09E-04 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 19 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0203 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 2 RELEASE ACTIVITY: PROC/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 

400.00 High 

EPA SANITIZED Page 20 of 68
2/25/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0203 Assessor: Wong/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:3 Number of Release Sites: 

 Release Activity: PROC/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 21 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0203 

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

SCENARIO #: 3 Number of Sites: RELEASE 

ACTIVITY:PROC/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 7.49E-03 1.88E-02 2.76E-02 3.40E-02

ALL 10 0.13 0.26 0.42 0.47 

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 4.00E-08 6.99E-07 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 2.05E-06 3.58E-05 mg/L 0.00 0.00 mg/kg 

Acute 

ADRpot 1.57E-06 2.16E-05 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 22 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0203 

SIC CODE EXPOSURES TO SURFACE WATER RELEASES 

SCENARIO #: 3 RELEASE ACTIVITY: PROC/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 

400.00 High 

EPA SANITIZED Page 23 of 68
2/25/11 page of 

 INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0203 Assessor: Wong/SS 

ENVIRONMENTAL RELEASES 

 Scenario#:4 Number of Release Sites: 

 Release Activity: PROC/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 24 of 68
2/25/11 page of 

INITIAL REVIEW EXPOSURE REPORT 

 Chemical ID: P-11-0203 

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

SCENARIO #: 4 Number of Sites: RELEASE 

ACTIVITY:PROC/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 1.60E-07 2.79E-06 mg/kg/day 0.00 0.00 mg/kg/day 

LADCpot 8.20E-06 1.43E-04 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 25 of 68
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INITIAL REVIEW EXPOSURE REPORT 

Chemical ID: P-11-0203 

INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) 

SCENARIO #: 4 RELEASE ACTIVITY:PROC/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): 0.74 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) 5.43E-05 N/A 30.00 75.00 71.80 0.55 

LADCpot (mg/m3) 2.95E-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 26 of 68
2/25/11 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 27 of 68
A-004 

TSCA Section 5(e) Consent Order 

 and Determinations Supporting Consent Order 

 for PMN P-11-203

EPA SANITIZED Page 28 of 68
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: 

) 

) 

) 

) 

) 

1 ) P-1l-203 

) 

) 

) 

) 

) 

Consent Order and Determinations Supporting Consent Order 

EPA SANITIZED Page 29 of 68
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents ofPMN 

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 30 of 68
111 

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-11-203 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) ofTSCA 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 § 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 physicaVchemical testing on [ 

before 

September 30,2014. 

(b) maintain certain records. 

EPA SANITIZED Page 31 of 68
IV 

m. CONTENTS OF PMN 

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

document and agrees that all infonnation herein that is claimed as confidential by the Company 

is correctly identified within brackets and that any infonnation that is not bracketed is not 

claimed as confidential. To make this document available for public viewing, EPA will remove 

only infonnation contained within the brackets. 

Confidential Business Information Claims (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 salt 

Use: 

Specific: [ 

Generic: Paper treatment 

Maximum 12-Month Production Volume: [ ] kgs; 

] 

]; 

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

below): I) Determination of residual C6FMA amount in product; 2) "Test of Schematic Flow 

for Safety Evaluation of Polymers" (chemical and physical properties), plus tables and figures; 

and 3) Reverse Mutation Test Using Microorganisms. 

EPA SANITIZED Page 32 of 68
v 

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 ReproductionlDevelopmental Screening test (OECD 422); 2) PFHxA: 

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

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

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

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

Perfluorinated Acids in Rainbow Trout, Env. Toxicology and Chemistry vol. 22, no. 1 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. 

Submitted in 2006: 

1) A 90-day Repeated Dose Oral (gavage) Toxicity Study of Per flu oro hexanoic Acid (PFHxA) 

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

Submitted in 2011: Chronic Toxicity, Carcinogenicity study on PFHxA, Avian Reproduction 

study on PFHxA. 

EPA SANITIZED Page 33 of 68
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 and Fate Summary: EPA has concems for potential fluorinated 

incineration or other decomposition products of the PMN substance. EPA also has concems 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 info:rn;ation 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 

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, suggesting that the PMN 

substance could degrade in the environment under some conditions. EPA has concerns that these 

EPA SANITIZED Page 34 of 68
Vll 

degradation products will persist in the environment, could bioaccumulate or biomagnity, and 

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

including perfluorooctanoic acid (PFOA) and perflriorohexane 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 

summarized 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 AdministrativeRecord for PFOS, 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 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 

PMNs. A phannacokinetics study on PFHxA and for comparison perfluorobutane sulfonate 

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

EPA SANITIZED Page 35 of 68
viii 

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 4.4 years in 

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

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

reduced bioaccumulation ofPFHxA relative to PFOA. 

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

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

Alcohol. The EPA review of these subchronic and reproductive data onPFHxA 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 mg/kg/day. For reproductive or developmental 

effects, the NOAEL is 75 mglkglday and the LOAEL is 225 mg/kglday. 

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 mglkglday and were based on 

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

mg/kglday 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 

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

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

EPA SANITIZED Page 36 of 68
IX 

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

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

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

in the testes (2 males) and epididymides (l male) at 200 mg/kg/day and is a sign of concem 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 of the studies, there were some effects at the highest dose 

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

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

mg/kg/day 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 mglkg/day. 

EPA SANITIZED Page 37 of 68
x 

A Chronic Toxicity, Carcinogenicity stndy was submitted in 20 11. EPA is currently 

reviewing additional data concerning this stndy. 

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

enviromnental degradant of the PMN substance), in the data to date, than for PFOA. 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 substitnte for some uses of 

PFOA, 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 with another Company agreed to 

conduct a modified I-generation reproductive test in rats (OECD421, modified); and a two-year 

chronic toxicity/carcinogenicity test in rats (OECD 453). The modifications for the reproductive 

test include: (1) increase the parental sample size to 20, (2) the duration of the stndy 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/sexllitter can be randomly selected to follow until sexual matnration, and (8) the time of 

sexual matnation 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, 

EPA SANITIZED Page 38 of 68
Xl 

comparative data, especially on the pharmacokinetics ofPFHxA and other perfluorinated 

substances will be developed by testing of the National Toxicology Program (NTP) in the socalled Perfluoro Class Study. 

Environmental Effects Summary EPA expects the PMN substan.ce to be highly persistent. 

No ecotoxicological concerns were raised for the PMN polymer itself. However, there is high 

concern for possible environmental effects from the potential persistent degradation product 

PFHxA. As stated previously, the analog PFOA is persist,ent in the environment and has a long 

bioretention time in various species. It has lieen detected in a number of species of wildlife, 

including marine mammals. It is toxic to mammalian and other species. The presence in the. 

environment and toxicological properties ofPFOA continue to be investigated. Some limited 

acute ecotoxicological effects data exist on PFHxA in fish, daphnia, and algae. EPA believed 

that development of additional data was warranted and the Company agreed and has conducted 

an Avian Reproduction Test (OECD 206) on PFHxA. 

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. 

EPA SANITIZED Page 39 of 68
Xll 

The PMN substance will be imported and used as a [ 

]. This new chemical is intended to be used 

in [ ] settings only. 

In the processing ofthe PMN substance for use in [ 

], it is estimated that the substances could be used at I ] ~knowncustomer sites for 

days/per year. The PMN substance will be imported as a liquid at I ] % concentration in the raw 

material and duluted to [ ] PMN substance in the liquid product. The liquid will be 

mixed with other additives. The paper will be dipped in the solution containing the PMN 

substance and the paper will be dried and cured. 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 its use on paper, release of the 

perfluoro component is possible from the paper. 

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. 

EPA SANITIZED Page 40 of 68
Xlll 

(b) In light of the potentiallisk of human health and environmental effects posed by the 

ll1lcontrolled manufacture, impOli, processing, distribution in commerce, use, and disposal ofthe 

PMN substance, EPA has concluded, pursuant to § 5( e) (I )(A)(ii)(I) of TSCA, that ll1lcontrolled 

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

substance may present an ll1lreasonable 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 

imd potential degradation products,EP A has further concluded, pursuant to § 5( e)(l )(A)(ii)(I1) 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 REOUIRED 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 ofthe following information 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 the 

following or other relevant information. 

EPA SANITIZED Page 41 of 68
XlV 

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

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

substance, the following additional infonnation on PFHxA would be necessary 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 earlier in the 

Preamble); and a combined chronic toxicity/carcinogenicity test (OECDGuideline 453). The 

Company agreed to perfonn this testing. For the new animal toxicity testing, the Company 

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 necessary. These modifications will be agreed upon 

between EPA and the Company. 

2. Infonnation on inhalation toxicology ifthe 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 Guideline 870.3465 or OECD 413) or other relevant infonnation. 

EPA SANITIZED Page 42 of 68
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASHINGTON, D.C. 20460 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

OFFICE OF CHEMICAL SAFETY 

AND POLLUTION PREVENTION 

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

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

'J (P-11-203); (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 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 

Internet Address (URL) • htlp://wwwepa.gov 

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

EPA SANITIZED Page 43 of 68
2 

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

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

with TSCA §12(a) and (b), 40 CFR 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 PMNsubstance while in the territory ofthe 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 tenns of the Order, and count towards any production volume test triggers in 

the Testing section of this Order. 

(2) Research & DevelopmentCR&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 nO.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.3o(h), with no commercial purpose separate from the substance, mixture, or article of which 

EPA SANITIZED Page 44 of 68
3 

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 CFR 720.22(b)(I). 

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

Exemption (TME) under TSCA §5(h)(l) 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)(I) 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 substance, and the 

completion of EPA's review of, aild 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 

EPA SANITIZED Page 45 of 68
4 

import of the PMN substance by any other person. 

(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)(l) 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 ofSNUR. When EPA promulgates a final SNUR for the PMN substance and 

subparagraph (a)(l) 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 ofthe 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 form in which it appears in this Consent Order, the following information: 

(1) the PMN nwuber, 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. 

EPA SANITIZED Page 46 of 68
5 

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 ww.epagov/oppt/tsca8e. 

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

Assistance & 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 a,.,d 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 

EPA SANITIZED Page 47 of 68
6 

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 

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-11-203 beyond September 30, 2014 ("the production limit"), 

unless the Company conducts the following studies on the PMN substance described in [ 

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

specified in the Testing section of the aforementioned Order. 

Study Guideline 

Modified Semi-Continuous OPPTS 835.5045 

Activated Sludge (SCAS) with or OECD 302A 

Analysis for degradation products 

UV Visible Light absorption OPPTS 830.7050, OECD 101 

Direct photolysis, if wavelengths OPPTS 835.2210 

Greater than 290nm are absorbed in 

the previous test 

Photolysis on soil--

Phototransformation of Chemicals 

on Soil Surfacesc 2 soils 

Indirect photolysis screening test 

Draft OECD guideline 

Jan. 2002 

OPPTS 835.5270 

EPA SANITIZED Page 48 of 68
7 

Indirect photolysis screening test 

(Sunlight photolysis in waters 

Containing dissolved organic carbon) 

Hydrolysis as a function of pH 

Aerobic and Anaerobic Transformation 

In Aquatic Sediment Systems 

Anaerobic Biodegradability of Organic 

Compounds in Digested Sludge 

OPPTS 835.5270 

OECD III 

OEeD 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): C6FMA (monomer): CAS No. 2144-

53c8; 6-2 carboxylic acid: CAS No. 53826-12-3; 6-2 unsaturated carboxylic acid: CAS No. 

161094-75-3; 6-2 alcohol: CAS No. 647-42-7, C6 acid (PFHxA): CAS No. 307-24-4; 5-2 

sec.-alcohol: No CAS number, and 5-3 acid: No CAS number. 

EPA SANITIZED Page 49 of 68
8 

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 

telomer alcohol, CAS number: 647-42-7; Photolysis tests-identity the major fluorinated 

fragments and volatiles including 6:2 telomer alcohol; 6:2 carboxylic acid, tridecafluoro-l-octene 

(CF3(CF2)5CH=CH2), and tridecafluoroheptanoic acid (CF3(CF2)5C02H). 

(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. 

EPA SANITIZED Page 50 of 68
9 

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

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

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

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

specified in paragraphs (b), (c), and (e)(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 ofInvalid Data. 

(l) Except as described in subparagraph (h)(2), if, within 6 weeks ofEP A's receipt of a 

test report and data, the Company receives written notice that EPA fmds 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)(l). EPA will respond to the 

EPA SANITIZED Page 51 of 68
10 

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), ifthe Company becomes aware that 

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

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

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

substance beyond the applicable production limit. 

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

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

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

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

C0!llpany'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). Ifthere 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 

EPA SANITIZED Page 52 of 68
11 

(e)(3), the Company may exceed the production limit and shall submit the report and data in 

triplicate to EPA within a reasonable period of time, all as specified by EPA in the notice 

described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks 

of receiving the Company's report and data, as to whether the Company may continue to 

manufacture and import beyond the applicable production limit. 

(j) Unreasonable Risk. 

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

study are scientifically valid and unequivocal and indicate that, despite the tenns 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 

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

EPA SANITIZED Page 53 of 68
12 

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

receipt ofEP A'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 ofthe 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 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 ComparlY'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 54 of 68
13 

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 thePMN 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 mamtains, 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)(l )(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 kl-te 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 

EPA SANITIZED Page 55 of 68
14 

section; 

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

substance and the corresponding dates of manufacture and import; 

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

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

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

quantity of the substance sold or transferred on such date; 

(4) Records documenting the address of all sites of manufacture, 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) Applicability. The provisions of this Recordkeeping Section are applicable only to activities 

of the CompaI1Y and its Contract Manufacturer, if applicable, and not to activities of the 

Company's customers. 

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

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

EPA SANITIZED Page 56 of 68
15 

"collection of information" unless this Order displays a cun-ently valid control number from the 

Office ofManagernent 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. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Request for Information. Pursuant to section 11 of TSCA 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 purpose. 

EPA SANITIZED Page 57 of 68
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 (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). 

(I) Before NOe. 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 58 of 68
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 acquin,d 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 instrument(s) used to convey the interests in 

the PMN substance, including the right to manufacture the PMN substance, from the Company to 

the Successor in Interest. 

(d) Notices. 

(1) Notice to Successor in Interest, On or before the effective date of the transfer, the 

Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment 

B to this Order. 

(2) Notice to EP k Within 10 business days ofthe effective date of the transfer, the 

EPA SANITIZED Page 59 of 68
18 

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 IlofTSCA, 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) Liability. 

(I) 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 tenns 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 60 of 68
19 

volume ("testtriggern

), the aggregate volume ofthePMN substance manufactured and imported 

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

Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

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

effects of, or human exposure to, the PMN substance, to modifY or revoke substantive provisions 

of this Order. The exposures and risks identified by EPA during its review of the PMN 

substance and the infonnation 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 detennines 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 substill'1ce. 

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 61 of 68
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 of the review pe:tiod pursuant to section 5(e)(l)(B) ofTSCA, 

and to challenge the validity of this Order in any subsequent action. Consenting tothe 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 pTOceeding. This 

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

(b) CBI 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. 

Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

Date 

Title: 

Company: [ .] 

EPA SANITIZED Page 62 of 68
EPA SANITIZED Page 63 of 68
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 privateindividual 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 enj oyment. 

"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 ot common name used to identifYa. chemical substance or 

a mixture containing that substance. 

"hnmediate 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 64 of 68
2 

"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 (see TSCA s. 3(2» described in the 

Premanufacture notice submitted by the Company relevant to this Order. 

"Process stre.am" means all reasonably anticipated transfer, flow, or disposal ofa 

chemical substance, regal·dless 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 inapparent 

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 PlvIN 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 reasonablyanticipated 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 65 of 68
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 (Pl\AN) 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(3). 

3. Confidential Business Information. The Successor in Interest hereby: 

reasserts, 

_ relinquishes, or 

modifies 

all Confidential Business Information (CBl) 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 designatiou 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 66 of 68
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 67 of 68
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 68 of 68