# Support Documents for Significant New Use Rule (SNUR) on Premanufacture Notice (PMN) P-11-646

EPA Docket EPA-HQ-OPPT-2012-0450

# 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

# A-001 Structure Activity Team (SAT) Report for PMN P-11-646

### 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)

### 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

### 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

# A-002 Initial Review Engineering Report for PMN P-11-646

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0646 Focus Ready Draft 10/13/2011 ENGINEER: Hall \ JD PV (kg/yr):

SUBMITTER: USE:

OTHER USES:

CRSS :

### 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:

### 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

### 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:

### 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

# A-003 Initial Review Exposure Report for PMN P-11-64610/12/11 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 --- --- 1Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 2 Release activities are from engineering report's Manuf acturing (Mfg), Processing (Proc) and Use release activity labels.Multiple release activities are combined in one exposure scenario if their releases occur at same location. 3Exposure 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. 4This 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: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: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 ADR pot 2.07E-03 1.11E-02 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments: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 ADR pot

(mg/kg/day) 1.99E-03 N/A NA 1 day 71.80 0.55 Inhalation Comments: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 m10/12/11 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: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 ADR pot 2.07E-03 1.11E-02 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments: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 High10/12/11 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: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 ADR pot 1.93E-03 1.04E-02 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments: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 High10/12/11 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: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 ADR pot N/A N/A mg/kg/day N/A N/A mg/kg/day

SIC Code Comments: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 ADR pot

(mg/kg/day) N/A N/A NA 1 day 71.80 0.55 Inhalation Comments: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

# A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-11-6461.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 Order11 

### TABLE OF CONTENTS

Preamble I. Introduction 

### II. Summary ofTenns oftbe Order III. Contents ofPMN N. 

### EPA's Assessment ofExposure and Risk V. EPA's Conclusions ofLaw VI. Infonnation Required to Evaluate Human Healtb and Environmental Effects

Consent Order I. Scope ofApplicability and Exemptions 

### II. Tenns ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInfonnation III. Recordkeeping 

### N. Requests for Pre-Inspection Infonnation V. Successor Liability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order

Attachment A - Definitions Attachment B - Notice ofTransfer ofConsent Order111 I. 

### INTRODUCTION Under the authority of § 5(e) ofthe 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 ofthe 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 maybe 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.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 bythe Company is correctly identified within brackets and that any information that is notbracketed 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: [ ] kgsv Test Data Submitted with PMNs (many acronyms are subsequently explained in section N below): 1) "Test ofSchematic Flow for Safety Evaluation ofPolymers" (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 Toxicityin 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 Studyin 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 ofC6-2 Alcohol in Carp.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 ofthe 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 ofthe 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 ofthe PMN substance and for the subsequent perfluorinated products. The PMN substance is a derivative ofperfluorohexanoic 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 quantifiedVII 

### based on previously submitted Certificates ofAnalysis and other information. In 

### addition, the PMN substance is made in a facility that is dedicated to the production ofsubstances with C6 chemistry. EPA is concerned that perfluorinated products ofthe PMN substance maybe released to the environment from incomplete incineration ofthe 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 orbiomagnifY, and could be toxic (PBT) to people, wild mammals, and birdsbased 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 orprecursors, which is sunrmarized below·: PFOA is expected to persist for years in the environment. Biodegradation and photolysis tests ofanalogous substances indicate little orno biodegradation orphotolysis ofperfluoroalkyl compounds. Bioaccumulation concerns are based on the measured presence ofcertain 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 ofconcern. 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 theAdministrative Record for PFOS, PFOA, andVlll Telomers andRelated Chemicals (AR-226). AdministrativeRecord (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 ofthe PFHxA-derived polymers and other substances; see the PMN docket for data for these specific PMNs. A pharmacokinetics study onPFHxA 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 thehalf-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 ofone hour or less. These data support the assessment ofreduced 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 ofthese 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-primarilyliver effects-- were seen. EPA review places the No-Adverse Effect Level orNOAEL for PFHxA at 50 mglkglday. For the C6 alcohol, the doses

were 25, 75, and 225 mglkglday. For systemiceffects, 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.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/daybased on the body weight gain being lower in all treated groups ofmales. 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 activityhave also been seen in studies on PFOA. The significance ofthe finding ofa benign brain tumor (astrocytoma) in one male rat in the high dose group is not clear. It is not the type oftumor normally associated with PFOA-type compounds, is not a rare tumor, and maybe incidental. Abnormal histopathology was observed in the testes (2 males) and epididymides (1 male) at 200 mg/kg/day and is a sign ofconcern for male reproductive toxicity. Further testing should investigate male reproductive effects. From this study, the potential for immunotoxic effects is low. There havebeen some studies showing immunotoxic effects from PFOA. Anyinvestigation ofimmunotoxic effects should await the corroborative testing now being conducted byEPA, Office ofResearch and Development. There

were no clinical signs ofneurotoxicity 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 ofthose 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 ofone ofthe studies, there were some effects at the highest dose (500 mg/kg/day). These two studies had comparable dose levels.x A one-generation reproduction/developmental toxicity study in mice on the ammonium salt ofPFHxA 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 ofdevelopmental toxicity were observed at 175 mg/kglday on the postnatal day 1 and consisted ofincreases in the number ofstillborn 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 currentlyreviewing additional data concemingthis study. These and other data indicate a different and less toxic profile for PFHxA, (a presumed environmental degradant ofthe 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 maybe used as a major substitute for some uses ofPFOA, EPA believes that more information is needed on the toxicity ofPFHxA 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 ofthe 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)Xl dosing ofthe 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 ofsexual matuation should be recorded (i.e. vaginal opening and preputial separation). An avian reproduction test (OECD 206) has also been conducted bythe Company

.. In addition, comparative data, especially on the pharmacokinetics ofPFHxA and otherperfluorinated substances will be developed bytesting of the National Toxicology Program (NTP) inthe so-called Perfluoro Class Study.

Enviromnental Effects Summary: EPA expects the PMN substance to be highly persistent. No ecotoxicological concerns were raised for the PMN polymer itselfbased 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 inthe enviromnent and has a long bioretention time in various species. Ithas been detected in a number ofspecies ofwildlife, including marine mammals. Itis 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 ofadditional data is warranted and the Company has conducted an Avian Reproduction Test (OECD 206) on PFHxA.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 ofthe 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 ofrelease is

uncertain. The waste could be incinerated or landfilled. Ifincinerated, some releases ofthe 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 ofrelease ofthe perfluoro component from the textile materials. Ifthe substance is used on [

]. Exposure could also occur during [

. The substance is intended to be applied at the factory for [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 ofdegradants ofconcern from low temperature incineration orburning.



### V. EPA'S CONCLUSIONS OF LAW The following findings constitute thebasis ofthe 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 reasonedevaluation ofthe human health and environmental effects ofthe PMN substance and potential degradation products. B. In light ofthe potential risk ofhuman health and environmental effects posed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe 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 ofthe PMN substance maypresent an unreasonable riskofinjury to human health and the environment. C. In light ofthe estimated production volume of, and human exposureto, 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 mayreasonablybe anticipated to enter the environment in substantial quantities, and there maybe significant (or substantial) human exposure to the substance and potential degradation products.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 ofthis 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'srestrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance will remain in effect until the Order is modified orrevoked by EPA based on submission ofthe 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 ofthe PMN substance, the following additional information on PFHxA would be necessaty to evaluate the human health and environmental effects which maybe caused bythe 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 oftesting. Due to the limited water solubility ofsome ofthe substance and consequent analytical difficulties, some modification ofthe protocols maybe necessaty. These modifications will be agreed upon between EPA and the Company.xv 2. Information on inhalation toxicology ifthe substance was to be sprayed by commercial

orconsumer 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.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 ofthis 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 byparagraph (b).

(b) Exemptions. Manufacturing ofthe 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 ofthe following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section ofthis Order. (I) Export. Until the Companybegins commercial manufacture ofthe PMN substance for use in the United States, the requirements ofthis 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 Paper2 processing or distribution in commerce ofthe 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 activitybythe Company involving the PMN substance is exempt as "solely for export" even ifsome amount of the PMN substance is later exported. At that point, the requirements ofthis Order apply to all activities associated with the PMN substance while in the territory ofthe United States. Prior to leaving U.S. territory, even those quantities orbatches ofthe PMN substance that are destined for export are subject to terms ofthe Order, and count towards any production volUlne test triggers in the Testing section ofthis Order. (2) Research & Development (R&D). The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe 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 ofthis Order also do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance when manufactured solely for non-commercial research and developmentper 40 CFR n0.30(i) and TSCA §5(i). (3) Byproducts. The requirements ofthis 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 ofthis Order do not apply to the PMN substance when it is manufactured, pursuant to any ofthe exemptions in 40 CFR nO.30(h), with no commercial purpose separate from the substance, mixture, or article ofwhich it is a part.3 (5) Imported Articles. The requirements ofthis Order do not apply to the PMN substance when it is imported as part ofan "article" as defined at 40 CPR 720.3(c) and in compliance with 40 CPR 720.22(b)(l).

(c) Automatic Sunset. Ifthe 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 ("LVE") 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 automaticallyrendered null and void as ofthe effective date ofthis 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 ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substances, and the completion ofEPA'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 ofthe PMN substance by any other person.4 (2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation ofa final significant new use rule (SNUR) governingthe PMN substance under section 5(a)(2) ofTSCA unless the Company isnotified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. 

### Ifthe 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 ofthe SNUR affinned. (3) Notice ofSNUR. 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 ofthe existence ofthe SNUR.

DISTRIBUTION Export Notice Requirement. No later than the date ofdistribution, the Company shall notifY in writing anyperson to whom it distributes the PMN substance that, due to the issuance ofthis Consent Orderunder section 5(e) ofTSCA, the PMN substance is subjectto 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 ofthe PMN substance, or (B) ifthe 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 ofinjury to health or5 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 ofStudy Scheduling. The Company shall notifY, in writing, the EPA Monitoring Assistance & Media Program Division (2227A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study

. required to be performed pursuant to this Order, or within 15 days after the effective date ofthis Order, whichever is later: (1) The date when the study is scheduled to commence; (2) The name and address ofthe laboratory which will conduct the study; (3) The name and telephone number ofa 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 studyrequired 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 startingto conduct any study, the Companymust obtain review oftest protocols from EPA by submitting written6 protocols. EPA will respond to the Company within 4 weeks ofreceiving 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 ofa test protocol does not mean pre-acceptance oftestresults.

(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 ofthe 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, ifwavelengths OPPTS Test Guideline Greater than 290nm are absorbed in 835.2210 the previous test Photolysis on soil-- Phototransformation ofChemicals 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 835.52707 Hydrolysis as a function ofpH Aerobic and Anaerobic Transformation In Aquatic Sediment Systems Anaerobic Biodegradability ofOrganic Compounds in Digested Sludge OECD 111 OECD 308

OECD 311

(2) Chemical composition ofthe substance to be tested must be fully characterized. For polymers, characterization includes all information required on pages 5 and 6 ofthe PMN form, except that data on residuals are onlyrequired for fluorinated substances. Special characterization for unique properties ofinterest to EPA, which may include information claimed

as Confidential Business Information (CBI), mustbe confirmed either through experimental determination or through the Company certification that the express conditions used to manufacture the PMNsubstance are comparable to cited literature references (and theymustbe cited), that produce the unique properties ofinterest. 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 Companytest 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 maybe different than biodegradation, the Companymust test for the following analytes: Hydrolysis test-6:28 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 ofany interim phase of each study; and (3) submit, (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach 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 ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the submission ofsuch information is mandatory. EPA will require the submission ofraw data such as slides and laboratory notebooks onlyifEPA finds, on the basis of professionaljudgment, that an adequate evaluation ofthe study cannot take place in the absence ofthese items.

(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) ofthis Testing section ifnotified in writing by EPA that it is unnecessary to conduct that study.

(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal,9 the Company may continue to manufacture and import the PMN substance beyond the applicable production limit. To seek relieffrom any other restrictions ofthis Order, the Company may make a second attempt to obtain unequivocal data byreconducting the studyunder the conditions specified in paragraphs (b), (c), and (e)(l) and (2). The testing requirements maybe modified, as necessary to permit a reasoned evaluation ofthe risks presented bythe PMN substance, only by mutual consent ofEPA and the Company.

(h) EPA Determination ofInvalid Data. (I) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report and data, the Companyreceives written notice that EPA finds that the data generated by a study are scientifically invalid, the Company is prohibited from further manufacture and import ofthe 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 ifso notified, in writing, byEPA in response to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Company mayreconduct the study in compliance with paragraphs (b), (c), and (e)(l) and (2). Ifthere 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). Ifthere 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 oftime, all as specified by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data.10 (ii) The Company may, within 4 weeks ofreceiving 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 ofreceiving the Company's report.

(i) Company Determination ofInvalid Data. (I) Except as described in subparagraph (i)(2), ifthe Company becomes aware that circumstances clearly beyond the control ofthe Company or laboratory will prevent, orhave prevented, development ofscientifically valid data nnder the conditions specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks offrrst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearlybeyond the control of the Company or laboratory will cause or have caused development of scientifically invalid data. EPA will notify the Company ofits response, in writing, within 4 weeks ofreceiving 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). 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). Ifthere 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 in11 triplicate to EPA within a reasonable period oftime, all as specified byEPA in the notice described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data, as to whether the Companymay 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 ofthis Order, the PMN substance will ormaypresent an unreasonable risk ofinjury 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 ofthe PMN substance to mitigate exposures to orto better characterize the risks presented by the PMN substance. Within 2 weeks from receipt ofsuch a notice, the Companymust cease all manufacture, import, processing, distribution, use and disposal ofthe 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 ofthe 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 ofthe PMN substance in accordance with the tenns ofthis Order pending.EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks of12 receipt ofEPA'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 ofthe PMN substance.

(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continue to obey all the terms ofthis 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 ofthis Consent Order pursuant to Part IV. ofthis Consent Order.

RISK NOTIFICATION (a) Ifas a result ofthe test data required under the terms ofthis Order, the Company becomes

aware that the PMN substance maypresent a risk ofinjury to human health orthe 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 ofthe new information. Ifthe PMN substance is not being manufactured, imported, processed, orused in the Company's workplace, the Companymust 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 Companybecomes aware ofthe new information described in paragraph (a) ofthis13 section, are provided an MSDS containing the infonnation required under paragraph (a) within 90 days from the time the Companybecomes aware ofthe 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 byEPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the PMN substance did in fact qualifY for any

one or more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfY all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed bythe Company. Any amounts or batches ofthe PMN substance eligible for the Export exemption in Section I, Paragraph (b)(1) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, copies ofthe export label and export notice to EPA,·required byTSCA sections 12(a)(1)(B) and12(b), respectively. Any amounts or batches ofthe PMN substance eligible for the Research and Development exemption in Section I, Paragraph (b)(2) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records required by40 CFR 720.78(b). For any amounts orbatches ofthe PMN substance claimed to be eligible for any other exemption described in Section I, Paragraph (b) ofthis 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;14 (2) Records documenting the manufactnre and importation volume ofthe PMN substance and the corresponding dates ofmanufactnre and import; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufactnre or import to whom the Company directly sells or transfers thePMN substance, the date ofeach sale or transfer, and the quantity ofthe substance sold or transferred on such date; (4) Records documenting the address ofall sites ofmanufactnre, import, processing, and use; (5) Copies ofmaterial safety data sheets required bythe Risk Notification section ofthis Order; (6) Records documenting compliance with the Manufacturing and Distribution sections; (7) Copies ofany Transfer Documents and notices required bythe Successor Liability section ofthis Order, ifapplicable; and (8) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substance are manufactured, imported, processed, orused.

(b) Applicabilitv. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Company and its Contract Manufactnrer, ifapplicable, and not to activities ofthe 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 ofinformation" unless this Order displays a currently valid control number from the15 Office ofManagement and Budget ("OMB"), and EPA so informs the Company. The "collection ofinformation" 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 ofCompany 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 ofsuch inspections. Such requests maybe written or oral. The types ofinformation 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 reasonablybe exposed to the PMN substance; (iii) Currentjob titles or categories for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance and may reasonablybe exposed to the PMN substance; (v) Records required bythe Recordkeeping section ofthis Order; and/or (vi) Any other information reasonably related to determining compliance with thisOrder

or conducting an inspection for that pmpose.16 (b) Company's Response. The Company shall respond to such requests within a reasonable period oftime, but in no event later than 30 days after receiving EPA's request. When requested in writing byEPA, the Company's response shall be in writing. To the extent the information is known to orreasonably ascertainable to the Company at the time ofthe request, the Company's response shall demonstrate a good faith effort to provide reasonably accurate and detailed

answers to all ofEPA'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 bywhich the Company's rights and obligations under this Order maybe transferred when the Company transfers its interests inthe PMN substance, including the right to manufacture the PMN substance, to another person outside the Company (the "Successor in Interest").

(b) Relation ofTransfer Date to Notice ofCommencement !NOC). (1) Before NOC. Ifthe transfer from the Company to the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture orimport ("NOC") for the PMN substance from the Companypursuant 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 ofthe PMN substance.17 (2) After NOC. Ifthe transfer from the Companyto the Successor in Interest is effective

.after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and shall not be required to submit new PMNs to EPA.

(c) Definitions. The following definitions apply to this Successor Liability section ofthe 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 bythe Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Company in the PMN substance, such as a licensee who has acquired a limited license to the patent or manufacturing rights associated withthe PMN substance. A Successor in Interest mustbe incorporated, licensed, or doing business inthe United States in accordance with 40 CFR 720.22(3). (2) "Transfer Document" meansthe 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 orbefore the effective date ofthe transfer, the Company shall provide to the Successor in Interest, byregistered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment B to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the·18 Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: 

## u.s. Enviromnental Protection Agency, NewChemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document must be maintained bythe Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substance is manufactured or imported. Copies ofthe Transfer Document must also be made available for inspection pursuant to Section 11 ofTSCA, must state the effective date and time oftransfer, and must contain provisions which expressly transfer liability for the PMN substance under the terms ofthis Order from the Company to the Successor in Interest.

(e) Liabilitv. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective date and time ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date and time oftransfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken,

or omissions made, during the time in which the Companymanufactured, processed, used, distributed in commerce, or disposed ofthe PMN substance pursuant to the terms ofthis Consent Order.

(f) Obligations to Submit Test Dataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Orderrequires the Company to submit test data to EPA at a specified production19 volume ("test trigger"), the aggregate volume ofthe PMN substance manufactured and imported bythe Companyup to the date oftransfer shall count towards the test trigger applicable to the Successor in Interest.

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company maypetition EPA at any time, based upon new information on the health effects of, orhuman exposure to, the PMN substance, to modif'y or revoke substantive provisions ofthis Order. The exposures and risks identified byEPA during its review ofthe 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, anyreassessment ofthe test data or other information that supports the findings in this Order, an examination ofnew test data or other information or analysis, and any otherrelevant information. EPA will issue a modificationor revocation ifEPA determines that the activities proposed therein will not present an unreasonable risk ofinjury to health orthe environment and will not result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects ofthe PMN substal1ce. In addition, the Company maypetition EPA at any time to make other modifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.

### 20 VII. EFFECT OF CONSENT ORDER (a) Waiver. By consenting to the entry ofthis Order, the Company waives its rights to file objections to this Orderpursuant to section 5(e)(l)(C) ofTSCA, to receive serviceofthis Order

no later than 45 days before the end ofthe review period pursuant to section 5(e)(l)(B) ofTSCA, and tochallenge the validity ofthis Order in any subsequent action. Consenting to the entry of this Order, and agreeing to beboundby its terms, do not constitute an admission bythe 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 mayhave under TSCA.

(b) CEl Brackets. By signing this Order, the Companyrepresents that ithas carefully reviewed this document and hereby agrees that all information herein that is claimed as confidential bythe 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 notbracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove onlythe information contained within the brackets.

# /l;l~' ,VlCVVc

Director Chemical Control Division Office ofPollution Prevention and Toxics 

# :5 

# (z:s**l~'** zDate

Company: [ ]ATTACHMENT A DEFINITIONS

Note: The attached Order may not contain some of the terms defined below. "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system ofChemical Abstracts Service's rules ofnomenclature, or a name which will clearly identifY a chemical substance for the purpose ofconducting a hazard evaluation. "Company" means the person orpersons subject to this Order. "Commercial use" means the use ofa 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 anypersonal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa 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 ofthis 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. ofthis 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 isfor the "immediate use" ofa person ifit is under the control of, and used onlyby, the person who transferred it from a labeled container and will onlybe used bythat person within the work shift in which it is transferred from the labelled container.3 "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health ofthe U.S. Department ofHealth 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 ofthe 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, orprocessed. "PMN substance" means the chemical substance (see TSCA s. 3(2» described in the Premanufacture notice submitted bythe Company relevant to this Order.

"Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofprocessing, including the cleaning ofequipment. "Scientifically invalid" means any significantdeparture 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 ofthe health or environmental effects ofthe 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 ofinjury to human health or the environment ofthe PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-tenn containment ofthe 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 ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Workplace" means an establishment at one geographic location containing one ormore work areas.Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER

PMNNumber

1. Transfer ofManufacture Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor inInterest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofa 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) ofthe Toxic Substances. Control Act (TSCA, 15 U.S.C. §2604(e».

2. Assumption ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed bythe applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe 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 bythe original submitter) would not subsequently be eligible for confidential treatment under this Notice ofTransfer.2 TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER

Company (Transferor)

Signature ofAuthorized Official NOTICE OF TRANSFER (continued)

PMNNumber

Date

Printed Name ofAuthorized Official

Title ofAuthorized Official

Successor in Interest

Signature ofAuthorized Official Date

Printed Name ofAuthorized Official

Title ofAuthorized Official

Address City, State, Zip Code3

TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER NOTICE OF TRANSFER (continued)

Successor's Technical Contact

Address City, State, Zip Code

Phone