# Support Documents for Significant New Use Rules (SNUR) on Premanufacture Notice (PMN) P-11-384

EPA Docket EPA-HQ-OPPT-2012-0450

# Index A-001 Structure Activity Team (SAT) Report for PMN P-11-384 A-002 Initial Review Engineering Report for PMN P-11-384 A-003 Initial Review Exposure Report for PMN P-11-384 A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-11-384

# A-001 Structure Activity Team (SAT) Report for PMN P-11-384

### SAT Report PMN Number: P-11-0384 SAT Date: 6/3/2011 Print Date: 3/1/2012 Related cases: Health related cases: Ecotox related cases: Analogs: Concern levels: 

### Type of Concern: Health Eco Comments Level of Concern: 1 1 Health: PMN substance; Eco: 1-2 Health: Incomplete incineration product; Eco: Persistence Bioaccum Toxicity Comments 3 1 1 PMN 3 1 2

Exposure Based Review: Health: No Ecotox: No Routes of exposure: Health: No exposures needed for the PMN substance; drinking water and inhalaiton for Ecotox: No releases to water Fate:; Keywords: Keywords: LIVER, BLOOD, KIDNEY, DEVEL Summary of Assessment: Fate: Fate Summary: P-11-0384

POTW removal (%) = 90 via sorption; Analog OPPTS

### (sediment 0.485yrs NS(Aerob. Biodeg w/ Sewage):9.2 mole-%/41d; NS(Aerob Biodeg-FW Sediment):6.78 mole %/61d, 9.23 mole-%/20d; NS(Anaerob. Biodeg. w/ Digester Sludge): 7.71 mole-%/21d; NS(Anaerob. Biodeg. w/ Anaerobic Sediment): 2.87 mole-%/119 days. Time for complete ultimate aerobic biodeg ≥mo Sorption to soils/sediments = v.strong PBT Potential: *CEB FATE: Migration to ground water = negl Health: Health Summary:Absorption is nil all routes as the neat material (pchem); poor all routes for the low molecular weight fractions if in solution (analog). No significant health concerns for the PMN substance. Concerns for the incomplete incineration product are liver toxicity, blood toxicity (anemia), kidney toxicity, and developmental toxicity based on studies with submitted for a PMN analog (Rat 10-day oral NOAEL = 300 mg/kg/d, some evidence of liver toxicity; rat 28-day oral NOAEL = 100 mg/kg/d, with changes in blood chemistry at higher doses; rat 90-day oral NOAEL = 60 mg/kg/d with hematological findings consistent with anemia at 200 mg/kg/d and higher; rat oral reproductive toxicity NOAEL = 1000 mg/kg/d for reproductive toxicity, 100 mg/kg/d for systemic toxicity with effects to the liver and kidney at 1000 mg/kg/d; rat oral developmental toxicity NOAEL = 300 mg/kg/d for both developmental effects (decreased fetal weight) and maternal toxicity). Ecotox: Test Organism Test Type Test End Point Predicted Measured Comments fish 96-h LC50 * daphnid 48-h LC50 * green algal 96-h EC50 * fish

_ chronic value * daphnid

_ chronic value * algal

_ chronic value * Sewage Sludge 3-h EC50

_ Sewage Sludge

_ Chronic Value _ Ecotox Values Comments: Predictions are based on SARs for ; SAR chemical class = MW ; pH7; effective concentrations based on 100% active ingredients and nominal concentrations; hardness <150.0 mg/L as CaCO3; and TOC <2.0

### mg/L; Factors Values Comments Assessment Factor 10 Concentration of Concern (ppb) * SARs SAR Class Ecotox Category Ecotox Factors Comments: SAT Chair: L Keifer 564-8916

# A-002 Initial Review Engineering Report for PMN P-11-384file:///J|/INITENG/P11%20cases/p110384.sr.txt[3/1/2012 8:44:36 AM] 

### INITIAL REVIEW ENGINEERING REPORT PMN: 11-0384 Standard Review Draft 6/30/2011 ENGINEER: El-Zoobi \ BCS PV (kg/yr): Revision Notes / Assessment Overview: =====>SR: no changes were made to the IRER SUBMITTER: USE:

OTHER USES:file:///J|/INITENG/P11%20cases/p110384.sr.txt[3/1/2012 8:44:36 AM] 

### CRSS :

SAT(concerns) (06/03/2011): Related Cases and Related Cases and Misc SAT Info: Ecotox Analogs: Migration to groundwater: Negligible PBT rating: P3B1T2 PMN: P3B1T1 // Incin Pdt: P3B1T2 Health: 1-2 Drinking Water, Inhalation Eco: 1 No releases to Water OCCUPATIONAL EXPOSURE RATING: 0-1 NOTES & KEY ASSUMPTIONS: Generated by the 06/07/2005 version of ChemSTEER.file:///J|/INITENG/P11%20cases/p110384.sr.txt[3/1/2012 8:44:36 AM] 

### POLLUTION PREVENTIONCONSIDERATIONS: P2 Claim:

EXPOSURE-BASED REVIEW: No INITIAL REVIEW ENGINEERING REPORT PMN: 11-0384 MFG: Number of Sites/ Location: 2 3M Decatur Plant Decatur AL 35609-2206 3M Cottage Grove Cottage Grove MN 55016 Days/yr: 42 Basis:file:///J|/INITENG/P11%20cases/p110384.sr.txt[3/1/2012 8:44:36 AM] 

### 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.file:///J|/INITENG/P11%20cases/p110384.sr.txt[3/1/2012 8:44:36 AM] 

### OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEWENGINEERING REPORT PMN: 11-0384 PROC/USE: Number of Sites/ Location: 7 unknown sites Days/yr: 250

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.file:///J|/INITENG/P11%20cases/p110384.sr.txt[3/1/2012 8:44:36 AM] 

### OCCUPATIONAL EXPOSURESESTIMATE SUMMARYfile:///J|/INITENG/P11%20cases/p110384.sr.txt[3/1/2012 8:44:36 AM]

# A-003 Initial Review Exposure Report for PMN P-11-384June 8, 2011 page of


### INITIAL REVIEW EXPOSURE REPORT (IRExR) Chemical ID: P-11-0384 Reviewer: Kwon/JB 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 = PDM Days Exceeded 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

--- --- --- --- --- --- --- 4.23E-02 --- --- --- --- --- --- --- --- --- --- --- 3.88E-04 --- --- 1.73E-02 --- --- --- --- --- --- --- --- --- --- --- 3.66E-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:June 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT
Chemical ID: P-11-0384 Assessor: Kwon/JB ENVIRONMENTAL RELEASES Scenario#:1 Number of Release Sites: Release Activity: 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:June 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT Chemical ID: P-11-0384 INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) SCENARIO #: 1 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): 5.27 μg/m3 Max 24 Hour Average Air Concentration (Stack): 230.00 μg/m3

ASSUMPTIONS Exposure Units Results (Stack) Results (Fugitive) ED (years) AT (years) BW (kg) Inh. Rate (m3/hr) Cancer LADDpot (mg/kg/day) 3.88E-04 N/A 30.00 75.00 71.80 0.55 LADCpot (mg/m3) 2.11E-03 N/A 30.00 75.00 NA NA Acute ADR pot

(mg/kg/day) 4.23E-02 N/A NA 1 day 71.80 0.55 Inhalation Comments:June 8, 2011 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 mJune 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT
Chemical ID: P-11-0384 Assessor: Kwon/JB ENVIRONMENTAL RELEASES Scenario#:2 Number of Release Sites: Release Activity: 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:June 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT Chemical ID: P-11-0384 INHALATION EXPOSURE ESTIMATES (POST-TREATMENT) SCENARIO #: 2 RELEASE DESCRIPTION: METHOD OF CALCULATION: Screen3 EXPOSED POPULATION: Adult Number of Sites: Per Site Fugitive Release: kg/site/day Fugitive Release Days per Year: days % Removal via Fugitive Release: % Total Fugitive Release: kg/yr Max Annual Average Air Concentration (Fugitive): 0.00 μg/m3 Max 24 Hour Average Air Concentration(Fugitive): N/A μg/m3
Per Site Stack Release: kg/site/day Stack Release Days per Year: days % Removal via Stack Release: % Total Stack Release: kg/yr Max Annual Average Air Concentration (Stack): 5.27 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) 3.88E-04 N/A 30.00 75.00 71.80 0.55 LADCpot (mg/m3) 2.11E-03 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:June 8, 2011 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 mJune 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT
Chemical ID: P-11-0384 Assessor: Kwon/JB ENVIRONMENTAL RELEASES Scenario#:3 Number of Release Sites: Release Activity: 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:June 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT Chemical ID: P-11-0384 SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES SCENARIO #: 3 Number of Sites: SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: Adult
WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 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 50 288.00 123.84 78.18 66.05 9.55 22.21 35.18 41.64 ALL 10 39.60 13.29 7.76 7.57 69.44 206.92 354.38 363.28

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 1.59E-05 1.16E-04 mg/kg/day 0.00 0.00 mg/kg/day LADCpot 8.16E-04 5.94E-03 mg/L 0.00 0.00 mg/kg Acute ADR pot 1.86E-03 1.73E-02 mg/kg/day 0.00 0.00 mg/kg/day

SIC Code Comments:June 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT
Chemical ID: P-11-0384 Assessor: Kwon/JB ENVIRONMENTAL RELEASES Scenario#:4 Number of Release Sites: Release Activity: 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:June 8, 2011 page of
INITIAL REVIEW EXPOSURE REPORT Chemical ID: P-11-0384 SIC-CODE BASED HUMAN AND AQUATIC EXPOSURES TO SURFACE WATER RELEASES SCENARIO #: 4 Number of Sites: SIC-CODE DESCRIPTION: POTW (Indust., includes POTWs which receive ind. disch.) SIC-CODE (S): Subset of 4952 EXPOSED POPULATION: Adult
WWT REMOVAL (%) RELEASE DAYS PRETREATMENT RELEASE (kg/site/day) POSTTREATMENT RELEASE (kg/site/day) DWT (%) BCF (L/kg) 0.00 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 50 288.00 123.84 78.18 66.05 N/A N/A N/A N/A ALL 10 39.60 13.29 7.76 7.57 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 5.04E-05 3.66E-04 mg/kg/day 0.00 0.00 mg/kg/day LADCpot 2.58E-03 1.88E-02 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:June 8, 2011 page of

# A-004 TSCA Section 5(e) Consent Order and Determinations Supporting Consent Order for PMN P-11-38411 TABLE OF CONTENTS Preamble I. Introduction II. Summary ofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofExposure and Risk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health and Environmental Effects
Consent Order I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Recordkeeping IV. Requests for Pre-InspectionInformation 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 

## PREAMBLE
I. INTRODUCTION Under the authority of § 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e», the Environmental ProtectionAgency ("EPA" or"the Agency") issues the attached Order, regarding premanufacture notice ("PMN") P-ll"0384 for the chemical substance

("the PMN substance") submitted by 3M Company ("the Company"), to take effect upon expiration of the PMN review period. The Company submitted the PMN to EPA pursuant to § 5(a)(I) of TSCA and 40 CFR Part 720. Under § 15 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 liabilitypursuant to § 16, and to specific enforcement and seizure pursuant to 

### § 17. In addition, chemical substances subject to an Order issued under 

### § 5 of TSCA, such as this one, are subject to the § 12(b) export notice requirement.

II. SUMMARY OF TERMS OF THE ORDER The Consent Order for the PMN substance requires the Company to: (a) submit to EPA certain fate testing at least 14 weeks before manufacturing or importing a total of 150,000 kilograms ofthe PMN substance and further fate testing at least 14 weeks before manufacturing or importing a total of550,000 kilograms ofthe PMN substance;IV (b) notifY customers ofthe applicability ofTSCA §12(b) export notice requirements for the PMN substance; and, (c) maintain certain records.

III. CONTENTS OF PMN By signing this Order, the Companyrepresents that it has carefully reviewed this document and agrees that all informationherein that is claimed as confidential bythe Company is correctly identified within brackets and that any information thatis not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within the brackets.

Confidential Business Information Claims (Bracketed in the Preamble and Order): chemical identity, impurities, production volume, manufacture, processing, use, pollution prevention, MSDS, physical/chemical properties, and environmental degradation information Chemical Identity: Specific:

Generic: Fluorinated alkylsulfonamidol urethane polymer Use: Specific: Generic: protective treatment Maximum 12-Month Production Volume:v Test Data Submitted with PMN: none

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK The following are EPA's predictions regarding the probable toxicity, hmnan exposure and environmental release ofthe PMN substance, based on the infonnation currently available to the Agency. Hmnan Health Effects and Fate Summary. EPA has concerns for potential incineration or other decomposition products ofthe PMN substance. EPA also has concerns that under some conditions ofuse, particularly non-industrial, commercial, or eonsumer use, the PMN substance could cause lung effects, based on limited data on some perfluorinated compounds. Concerns for the PMN substance are for lung toxicity from waterproofing oflung membranes, based on PMN properties. Concerns for the potential ultimate perfluorinated degradation products are for liver toxicity, blood toxicity (anemia), kidney toxicity, and developmental toxicity at high doses, based on PFBS. Carcinogenicity ofPFBS has not been tested in animals. EPA has concerns for the potential degradation products, byproducts, unreacted material and low molecular weight species. The PMN substance is a derivative of and may degrade to formperfluotobutane sulfonate ("PFBS") and not further degrade. PFBS is persistent and mobile in the environment. Concerns for the PMN substance are based on data on PFBS and analogy ofPFBS to PFOS. T'nermal degradation analysis ofstructurally similar substances demonstrate that the perfluoro component maybe released to the environment from incomplete incineration at low temperatures. Also, preliminary evidence 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,VI could bioaccumulate, and could betoxic ("PBT") to people, wild mammals, and birds, based on data on the PFOS analog chemicals. PFOS is expected to persist for years in the environment. Biodegradation and photolysis tests ofanalogous substances indicate little or no biodegradation or photolysis ofperfluoroalkyl compounds. Bioaccumulation concerns are based on concerns raised bythe measured presence ofcertain perfluoroalkyl compounds with longer carbon chain lengths, including PFOS, in wildlife and in human blood samples. Toxicity studies on PFOS indicate developmental, reproductive and systemic toxicity in various species. These factors, taken together, raise
concerns for potential adverse chronic effects in humans and wildlife. For information about PFOS, see HazardAssessment andBiomonitoringData onPerfluorooctane Sulfonate (PFOS), which can be found in docket number OPPT-2002-0043-0010. Additional information about PFOS may also be found in theAdministrative Record/orPFOS, 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) 566C 0280,
or by sending an email request to ncic.oppt@epa.gov. Toxicological, ecological, and fate data now exist on PFBS and some ofthe PFBSderived polymers and other substances; see the PMN docket for data for these specific PMNs. A pharmacokinetics study on PFBS in the Cynomolgus Monkey was submitted with a Prenotice Commmrication_) for a PMN**substance~** and later finalized_ This study indicates that the serum half-life ofPFBS in these monkeys is less than 24 hours. A subsequent epidemiological study shows that the half-life ofPFBS in humans is approximately one monili, whereas the half-life ofPFOS in monkeys is 200 days and in humans is approximately 5.4 years (OECD Hazard Assessment ofPerfiuorooctane Sulfonatevii ("PFOS") and its Salts, 2002, also found in OPPT-2002-0043-0023). These data and assessments support the assessment ofreduced bioaccumulation ofPFBS relative to PFOS. EPA reviewofthe subchronic and reproductive data on PFBS show subchronic effects to the liver, blood (anemia), kidney, and developmental toxicity. Although these and other data indicate a different and less toxic toxicological and ecological profile for PFBS in the test species in the

.data to date than for PFOS and PFOA, EPA believes that, based on the persistence ofPFBS, potential intermediate fate products, and the fact that these products maybe major substitutes for
some uses ofPFOS, more information is warranted on the fate and physical/chemical properties ofPFBS-derived polymers in the environment. EPA also believes that long-term toxicological testing on PFBS may be warranted, based on these factors and uncertainty.

Environmental Effects Summary: EPA expects the PMN substance to be highly persistent. Concerns for the PMN substance are low for aquatic toxicity. Further, concerns for the potential perfluorinated incomplete incineration products.are high for toxicity to terrestrial organisms based on PFOS and PFBS. However, no significant effects have been seen in the ecological data
on PFBS, the potential ultimate fate product, to date. EPA has evaluated the avian reproduction study on PFBS and found no significant effects. In addition, EPA is currently considering information on the ecotoxicology ofother potential fate products on the degradation pathway of these poiymers. As stated previousiy, the analogPFOS: is persistent in the environment and has
a long bioretention time in various species; has been shown to bioconcentrate in fish; has been detected in a number ofspecies ofwildlife, including marine mammals; and is toxic to mammalian and other species (OECD 2002). The presence in the environment and toxicological properties ofPFOS continue to be investigated.Vlll Exposure and Environmental Release Summary: Thermal and simulated incineration testing exists on related polymers This testing indicates that incomplete incineration products are formed at lowertemperatures. Modified Zahn-Wellens and SemiContinuous Activated Sludge ("SCAS") biodegradation tests have been conducted on some related polymers. EPAhas determined that some related polymers degrade. EPA has received and reviewed test data showing that certain polymers with perfluoroalkyl substituents degrade to form perfluoroalkyl-containing intermediates and perfluoroalkyl-containing organic acids. EPA expects that the PMN substance willdegrade in this way. EPA has determined that_l will follow similar degradation pathways and undergo expected chemical and metabolic reactions that are observed for

# _l.
Therefore, fate testing on

# _l

maybe used to estimate degradation ofP-ll-0384. Manufacturing at

- Inhalation exposures to workers are and dermal exposures . EPA predicts releases of

# _l
from
ProcessingIUse at 

# _J- Inhalation exposures to workers are and dermal exposures releases of

# _l
from . EPA predicts

V. EPA'S CONCLUSIONS OF LAW ofwaterIX The following findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine the potential for human health and environmental effects from exposure to the PMN substance and its potential degradants. EPA therefore concludes, pursuant to § 5(e)(l)(A)(i) ofTSCA, that the information available to the Agency is insufficient to permit
a reasoned evaluation ofthe human health and environmental effects ofthe PMN substance.
(b) In light ofthe potential risk ofhuman health and environmental effects posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, EPA has concluded, pursuant to § 5(e)(l)(A)(ii)(I) ofTSCA,that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance may present an unreasonable risk ofinjury to human health and the environment.
(c) In light ofthe estimated production volume ofand human exposure to the PMN substance, EPA has further concluded, pursuant to§ 5(e)(l)(A)(ii)(II) ofTSCA, that the PMN substance will be produced in substantial quantities and there maybe significant or substantial human exposure to the substance.

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 Testingsection.x Pended Testing. Becanse some concerns for the PMN substance are based on analogy to PFBS and PFOS, and because PFBS is a potential ultimate degradation product ofthe PMN substance, the following additional infonnation would be necessary to evaluate thehuman health and environmental effects which maybe caused by the PMN substance and its potential degradants: Test Description I) Combined chronic toxicity! carcinogenicity test on PFBS 2) health and ecotoxicity testing on degradants as dependant on the results ofthe triggered fate tests Guideline OPPTS 870.4300 or OECD453

The Order does not**r~quire** submission ofthe above pended testing at any specified time
or production volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance will remain in effect until the Order is modified or revoked byEPAbased on submission ofthat or other relevant infonnation.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 ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe chemical sulJstan(;e

CAS Number: ("the PMN substance") in the United States by 3M Company ("the Company"), except to the extent that those activities are exemptedby paragraph (b).
(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance is exempt from the requirements ofthis Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer OfConsent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable**requir~ments** of the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as

Internet Address (URL) • http://www.epa.gov Recycled/Recyclable· Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper-2- required in the Recordkeeping section ofthis Order. (1) Export. Until the Companybegins commercial manufacture ofthe PMN substance for
use in the United States, the requirements ofthis Order do not apply to manufacture, 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 Companybegins to manufacture the substance for use in the United States, no further activity by the Company involving the PMN substance is exempt as "solely for export" even ifsome amount ofthe PMN substance is later exported. At that point, therequirements 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 volume 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 development per 40 CFR nO.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 n0.30(h),- 3

- with no commercial purpose separate from the substance, mixture, or article ofwhich it is a part. (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 CFR 720.3(c) and in compliance with 40 CFR 720.22(b)(1).
(c) Automatic Sunset. Ifthe Companyhas obtained for the PMN substanc,e a Test Market Exemption ("TME") under TSCA §5(h)(1) and 40 CFR 720.38 or a Low Volume Exemption ("L VE") 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 ofthe effective date ofthis Consent Order.

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EV ALUATION OF INFORMATION
PROHIBITION The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe 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 substance, and the completion ofEPA's review of, and regulatory action based on, that information, except in accordance with the conditions described in this Order.- 4- TESTING (a) Section 8ee) Reporting. Reports ofinfonnation on the PMN substance which reasonably supports the conclusion that the PMN substance present a substantial risk ofinjury to health orthe environment, which is required to be reported underEPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978),68 Federal Register 33129 (June 3, 2003), and 70 Federal Register 2162 (January 12, 2005), shall reference the appropriate PMN identification number for this substance and contain a statement that the substance is subject to this Consent Order. Additional infonnation regarding section 8(e) reporting requirements can befound in the reporting guide referenced at 56 Federal Register 28458 (June 20, 1991).
(b) Notice ofStudy Scheduling. The Company shall notifY, in writing, the EPA Laboratory Data Integrity Branch (2225A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe following infonnation within 10 days ofscheduling any studyrequired to be perfonned 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 orthe 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.

### -5- (c) Good Laboratory Practice Standards and Test Protocols. Each study required to be performed pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific community at the time the study is initiated. Before starting to conduct any study, the Company must obtain review oftest protocols from EPA by submitting written protocols to EPA. EPA will respond to the Company within 4 weeks of receiving the written protocols. Anypublished test guidelines specified in this Order provide general guidance for development oftest protocols, but
are not themselves acceptable protocols. EPA review ofa test protocol does not mean**pre~** acceptance oftest results.
(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or importing the PMN substance beyond the following aggregate manufacture and import volumes ("the production limits"), unless the Company conducts the following studies on the PMN substance and analog

# _D
and submits all final reports and underlying data in accordance with the conditions specified in this Testing section.
Tier I Production limit is

Production limit is 

# - kgs Modified indirect photolysis screening test on the P-ll0384 substance
3M's aerobic activated sludge

. test on 

### the. substance lVl'UU>,Hv'U aerobic and

substance "''<11 YL1"> to identifY products, including unidentified peaks; add a control in the dark at three pHs to the indirect photolysis screening test to address hydrolysis Test protocol submitted by 3M onNovember 4, 20II has beenreviewed by EPA
Amend sludge to soil; addition of to identifY degradation products, including unidentified peaks-6-

(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 ofeach study; and (3) submit, in triplicate (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. EPAwill not require the submission ofraw data such as slides and laboratory notebooks unless EPA fmds, on the basis ofprofessionaljudgment, that an adequate evaluation ofthe study carmot take place in the absence ofthese items.
(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) of this 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, the Companymay continue to manufacture and import the PMN substance beyond the applicable production limit. To seek relieffrom any other restrictions ofthis Order, the Companymaymake
a second attempt to obtain unequivocal databy reconducting the studyunder the conditions specified in paragraphs (b), (c), and (e)(l) and (2). The testing requirements maybe modified, as-7-
necessary to permit a reasoned evaluation ofthe risks presented bythe PMN substance, onlyby mutual consent ofEPA and the Company.
(h) EPA Determination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report and data, the Company receives written notice that EPA finds that the data generated by
a study are scientifically invalid, the Company is prohlbited 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, by EPA 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 reconductthe 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. (ii) The Company may, within 4 weeks ofreceiving from EPA the notice described in subparagraph (h)(1), submit to EPA a written report refuting EPA's fmding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.

### - 8 - (i) Company Determination ofInvalid Data. (I) Except as described in subparagraph (i)(2), ifthe Company becomes aware that circumstances clearly beyond the contiol ofthe Company or laboratory will prevent, or have prevented, development ofscientifically valid data under the conditions specified in paragraphs (c) and (e), the Companyremains prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Company may submiHo EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearlybeyond the control ofthe Company or laboratory will cause orhave caused development ofscientificallyinvalid 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 Companyto 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 in triplicate to EPA within a reasonable period oftime, all as specified by EPA 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.-9-

(j) Unreasonable Risk. (I) 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 tenus ofthis Order, the PMN substance will ormay present an unreasonable risk ofinjury to human health or the enviromnent. EPA's notice may specifythat the Companyundertake certain actions concerning further testing, manufactnre,import, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposnres to or to 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: (2) within 2 weeks from receipt ofthe notice described in subparagraph (j)(I), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeksfrom receipt ofthe notice described in subparagraph (j)(I), the Company submits to EPAawritten 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 ofthe PMN substance in accordance with the tenus of this Orderpending 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 of receipt ofEPA's written response, the Company shall comply with anyrequirements imposedby EPA's response or cease all manufactnre, import, processing, distribution, use and disposal ofthe PMN substance.- 10- (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 VI. ofthis Consent Order.



### MANUFACTURING (a)(l) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import ofthe PMN substance by auy other person. (2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation ofa 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 ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe 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 ofthe 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 ofthe existence ofthe SNUR.



### DISTRIBUTION Export Notice Requirement. No later thau the date ofdistribution, the Company shall notifY in writing any person to whom it distributes the PMN substance that, due to the issuance ofthis- 11

- Consent Order under section 5( e) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in the fonn in which it appears in this Consent Order, the following information: (1) either the (A) PMN number, or (B) the corresponding CAS Number or Accession Number; and (2) either (A) the specific chemical identity ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity.



### III. RECORDKEEPING (a) Records. The Company shall maintain the following records until 5 years after the date they
are created and shall make them available for inspection and copying by EPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the PMN substance did in fact qualifY for any
one ormore 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 only 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 by TSCA sections 12(a)(1)(B) and 12(b), respectively. Any amounts orbatches 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- 12

- 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 (2) and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume ofthe PMN substance and the corresponding dates ofmanufacture and.import; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Company directly sells or transfers the PMN substance, the date ofeach sale or transfer, and the quantity of the substance sold ortransferred on such date; (4) Records documenting the address ofall sites ofmanufacture, import, processing, and use; (5) Records documenting compliance with the TSCA §12(b) export notice requirement in the Distribution section ofthis Order; (6) Copies ofany Transfer Documents and notices required by the Successor Liability section ofthis Order, ifapplicable; and, (7) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substance is manufactured or imported.
(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Company's customers.- 13

- (c) OMB Control Number. Underthe Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is not requiredto respond to this "collection of information" unless this Order displays a currently valid control number from the Office of Management and Budget ("OMB"), and EPA so informs the Company. The "collection of information" required in this TSCA §5(e) Consent Order has been approved under currently valid OMB Control Number 2070-0012.

IV. REOUESTS FOR PRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuantto section II ofTSCA and 40 CFR 720.122, EPA may occasionally 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 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 mayreasonably be exposed to the PMN substance; (iii) Currentjob 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 datafor workers who are involved in activities associated with the PMN substance and mayreasonably be exposed to the PMN substance; (v) Records required by the Recordkeeping section ofthis Order; and/or,- 14

- (vi) Any other information reasonably related to determining compliance with this Order
or conducting an inspection for that purpose.
(b) Company's Response. The Company shall respond to such requests within a reasonable period oftime, 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 orreasonably ascertainable by the Company at the time ofthe request, the Company's response shall demonstrate a good faith effort to providereasonably accurate and detailed answers to all ofEPA'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 bywhich the Company's rights and obligations under this Order maybe transferred when the Companytransfers 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 ofTransfer Date to Notice ofCommencement (''NOC''). (1) BeforeNOC. Ifthe transfer from the Companyto the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN- 15

- substance from the Company pursuantto 40 CFR nO.l02, the Successor in Interest must submit a
new PMN to EPA.and comply fully with Section 5(a)(I) ofTSCA and 40CFR part

## no before commencing manufacture or import ofthe PMN substance. (2) After NOC. Ifthe 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 ofthis Order and shall not be required to submit a new PMN 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 with the PMN substance. A Successor in Interest mustbe incorporated, licensed, or doing business in the United States in accordance with 40 CFR nO.22(a)(3) and 40 CFR nO.3(z). (2) 'Transfer Document" means the legal instrument(s) used to conveythe 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, by registered mail, a copy ofthe Consent- 16

- Order and the "Notice ofTransfer" document which is incorporated byreference as Attachment B to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals 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 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) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective date ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date 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.- 17

- (f) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Order requires the Company to submit test data to EPA at a specified production volume ("test trigger"), the aggregatevolume ofthe PMN substance manufactured and imported by the Company up 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 may petition EPA at any time, based upon new information on the human health or environmental effects of, or human exposure to or environmental release of, the PMN substance, to modifY orrevoke substantive provisions ofthis Order. The exposures and risks identified by EPA 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 m.akes that determination, including, where appropriate, any reassessment 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 modification or revocation ifEPA determines thatthe activities proposed therein will not present an unreasonable risk ofinjury to health or the 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 of the PMN substance.- 18

- 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.- 19

- VII. EFFECT OF CONSENT ORDER (a) Waiver. By consenting to the entry ofthis Order, the Company waives its rights to file objections to this Order pursuant to section 5(e)(I)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the eud ofthe review periodpursuant to section 5(e)(1)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound byits terms, do not constitute an admission by the Company as to the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights that the Companymayhave under TSCA.
(b) 

### CBI Brackets. By signing this Order, the Companyrepresents that it has carefullyreviewed 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, aud 40 CFR Part 2) is correctly identified within brackets aud that any information that is not bracketed is uot claimed as confidential. To make this document available for public viewing, EPA will remove onlythe information contained within the brackets. 

# fin

# M~:r,Director Chemical Control Division Date Office ofPollution Prevention and Toxics

Name: 'j 

## dATTACHMENT A DEFINITIONS Note: The attached Order may notcontain some of the terms defined below. "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed bythe Chemical Abstracts Service's rules of nomenclature, or a name which will clearly identifY a chemical substance for the purpose of conducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protectivebarrier to prevent dermal contact with chemical substances ofconcern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves,jackets, and pants. "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 any personal use or enjoyment. "Consumer product" 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 orresidence, 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 orpiping 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.2 "Immediateuse." A chemical substance is for the "immediate use" ofa person ifit is under the control of, and used only by, the person who transferred it from a labeled container and will onlybe used by that personwithin the work shift in which it is transferred from the labeled container. "Inipervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical or mechanical degradation, permeation, orpenetration ofthe chemical protective clothing under the conditions of, and the duration of, exposure. "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, ormixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe 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, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice

. submitted bythe Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the body to prevent contact with, and exposure to, an identified chemical substance or substances in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types ofrespirators. Barrier creams are not included in this definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of processing, including the cleaning ofequipment. "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 ofthe health or enviromnental effects ofthe PMN substance.3 "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk ofinjury to human health or the environment ofthe PMN substance
.

."Sealed container" means a closed container that is physically and chemically suitable for long-term containment ofthe PMN substance, and from which there will be no human exposure to, nor enviroumental 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. "Waters ofthe United States" has the meaning set forth in 40 CFR 122.2. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER

PMNNmnber
1. Transfer ofManufacture Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor in Interest") 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 by the applicable Consent Order limiting manufacture, processing, use, distribution in cOlumerce 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 nO.22(a)(3).
3. Confidential Business Infonnation. The Successor in Interest hereby: reasserts,

_ relinquishes, or modifies all Confidential Business Infonnation ("CBI") claims made bythe Company, pursuant to Section 14 ofTSCp
... a.."'1d 40 CFR pa..rt 2, for the P1,fl\.J 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. Infonnation which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBl by the 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 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

Successor's Technical Contact
Address City, State, Zip Code
Phone