Support Documents for 

Significant New Use Rules (SNUR) on 

Premanufacture Notice (PMN) 

P-11-384 

EPA Docket EPA-HQ-OPPT-2012-0450 

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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 

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A-001 

Structure Activity Team (SAT) Report 

for PMN P-11-384 

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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

EPA SANITIZED Page 4 of 63
(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 

EPA SANITIZED Page 5 of 63
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

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A-002 

Initial Review Engineering Report 

for PMN P-11-384 

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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:

 

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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. 

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POLLUTION PREVENTION CONSIDERATIONS:

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:

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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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

INITIAL REVIEW ENGINEERING 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.

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OCCUPATIONAL EXPOSURES ESTIMATE SUMMARY

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A-003 

Initial Review Exposure Report 

for PMN P-11-384 

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June 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 --- --- --- --- --- --- --- --- --- 

1 Exposure scenario titles consist of release activity followed by exposure calculation abbreviation. 

2 Release activities are from engineering report's Manufacturing (Mfg), Processing (Proc) and Use release 

activity labels. 

 Multiple release activities are combined in one exposure scenario if their releases occur at same location. 

3 Exposure calculations are Acute Dose Rate (ADR), Lifetime Average Daily Dose (LADD), and 

Probabilistic Dilution 

 Model (PDM). There may be one, two, or all three exposure calculations per exposure scenario. 

 CC is the aquatic concentration of concern. 

4 This column displays concentration values for the 7Q10 streamflow, which is defined as the average daily 

streamflow 

 of the seven consecutive days of lowest flow within a ten year period. 

Remarks: 

EPA SANITIZED Page 16 of 63
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: 

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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 

ADRpot (mg/kg/day) 4.23E-02 N/A NA 1 day 71.80 0.55 

Inhalation Comments: 

EPA SANITIZED Page 18 of 63
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 m 

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June 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: 

EPA SANITIZED Page 20 of 63
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 

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

Inhalation Comments: 

EPA SANITIZED Page 21 of 63
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 m 

EPA SANITIZED Page 22 of 63
June 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: 

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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 

ADRpot 1.86E-03 1.73E-02 mg/kg/day 0.00 0.00 mg/kg/day 

SIC Code Comments: 

EPA SANITIZED Page 24 of 63
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: 

EPA SANITIZED Page 25 of 63
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 

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

SIC Code Comments: 

EPA SANITIZED Page 26 of 63
June 8, 2011 page of 

EPA SANITIZED Page 27 of 63
A-004 

TSCA Section 5(e) Consent Order 

and Determinations Supporting Consent Order 

for PMN P-11-384 

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EPA SANITIZED Page 29 of 63
11 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents ofPMN 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Notice of Transfer of Consent Order 

EPA SANITIZED Page 30 of 63
111 

PREAMBLE 

I. INTRODUCTION 

Under the authority of § 5(e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C. 

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

Order, regarding premanufacture notice ("PMN") P-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 may be subject to various penalties and 

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of 

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

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for the PMN substance requires the Company to: 

(a) submit to EPA certain fate testing at least 14 weeks before manufacturing or importing a 

total of 150,000 kilograms of the PMN substance and further fate testing at least 14 weeks before 

manufacturing or importing a total of 550,000 kilograms of the PMN substance; 

EPA SANITIZED Page 31 of 63
IV 

(b) notifY customers of the applicability of TSCA § 12(b) export notice requirements for the 

PMN substance; and, 

( c) maintain certain records. 

III. CONTENTS OF PMN 

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

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

is correctly identified within brackets and that any information 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: 

EPA SANITIZED Page 32 of 63
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 of the 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 of the PMN substance. EPA also has concerns that under some 

conditions of use, 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 of structurally similar substances demonstrate that the perfluoro component may be 

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, 

EPA SANITIZED Page 33 of 63
VI 

could bioaccumulate, and could be toxic ("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 of analogous substances indicate little or no biodegradation or photolysis of perfluoroalkyl 

compounds. Bioaccumulation concerns are based on concerns raised by the measured presence 

of certain 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 Hazard Assessment and Biomonitoring Data on Perfluorooctane Sulfonate (PFOS), 

which can be found in docket number OPPT -2002-0043-0010. Additional information about 

PFOS may also be found in the Administrative Record/or PFOS, PFOA, and Telomers and 

Related Chemicals (AR-226). Administrative Record (AR-226) is not currently available online, . 

but copies can be requested on CD-ROM from the EPA Docket office by calling (202) 566C0280, 

or by sending an email request to ncic.oppt@epa.gov. 

Toxicological, ecological, and fate data now exist on PFBS and some of the 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 Sulfonate 

EPA SANITIZED Page 34 of 63
vii 

("PFOS") and its Salts, 2002, also found in OPPT -2002-0043-0023). These data and 

assessments support the assessment of reduced bioaccumulation ofPFBS relative to PFOS. EPA 

review ofthe 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 may be 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 of other potential fate products on the degradation pathway of 

these poiymers. As stated previousiy, the analog PFOS: 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 of species of wildlife, 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. 

EPA SANITIZED Page 35 of 63
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 lower temperatures. Modified Zahn-Wellens and SemiContinuous Activated Sludge ("SCAS") biodegradation tests have been conducted on some 

related polymers. EPA has 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 will degrade 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 may be used 

to estimate degradation ofP-ll-0384. 

Manufacturing at 

- Inhalation exposures to workers are 

and dermal exposures . EPA predicts 

releases of _l from 

ProcessingIU se at _J -

Inhalation exposures to workers are and 

dermal exposures 

releases of _l from 

. EPA predicts 

V. EPA'S CONCLUSIONS OF LAW 

of water 

EPA SANITIZED Page 36 of 63
IX 

The following findings constitute the basis of the Consent Order: 

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

exposure to the PMN substance and 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 of the human health and environmental effects of the PMN substance. 

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

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

PMN substance, EPA has concluded, pursuant to § 5(e)(l)(A)(ii)(I) ofTSCA,that uncontrolled 

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

substance may present an unreasonable risk of injury to human health and the environment. 

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

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 may be 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 

of this Order in accordance with the conditions specified in the Testing section. 

EPA SANITIZED Page 37 of 63
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 of the PMN 

substance, the following additional infonnation would be necessary to evaluate the human health 

and environmental effects which may be 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 of the triggered fate tests 

Guideline 

OPPTS 870.4300 or 

OECD453 

The Order does not r~quire submission of the 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 of the PMN substance will remain in effect until the 

Order is modified or revoked by EPA based on submission of that or other relevant infonnation. 

EPA SANITIZED Page 38 of 63
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 of the 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 exempted by 

paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe 

PMN substance is exempt from the requirements of this Order (except the requirements in the 

Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

extent that (1) these activities are conducted in full compliance with all applicable 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 

EPA SANITIZED Page 39 of 63
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required in the Recordkeeping section of this Order. 

(1) Export. Until the Company begins commercial manufacture of the PMN substance for 

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

distribution in commerce of the PMN substance solely for export in accordance with TSCA §12(a) 

and (b), 40 CFR nO.3(s) and 40 CFR Part 707. However, once the Company begins to 

manufacture the substance for use in the United States, no further activity by the Company 

involving the PMN substance is exempt as "solely for export" even if some amount of the PMN 

substance is later exported. At that point, the requirements of this Order apply to all activities 

associated with the PMN substance while in the territory of the United States. Prior to leaving 

U.S. territory, even those quantities or batches of the PMN substance that are destined for export 

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

Testing section ofthis Order. 

(2) Research & Development ("R&D"). The requirements of this Order do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in 

small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 

nO.3( cc), and 40 CFR n0.36. The requirements ofthis Order also do not apply to manufacturing, 

processing, distribution in commerce, use and disposal of the PMN substance when manufactured 

solely for non-commercial research and development per 40 CFR nO.30(i) and TSCA §5(i). 

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

it is produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR 

nO:3(d) and in compliance with 40 CFR nO.30(g). 

(4) No Separate Commercial Purpose. The requirements of this Order do not apply to the 

PMN substance when it is manufactured, pursuant to any of the exemptions in 40 CFR n0.30(h), 

EPA SANITIZED Page 40 of 63
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with no commercial purpose separate from the substance, mixture, or article of which it is a part. 

(5) Imported Articles. The requirements of this Order do not apply to the PMN substance 

when it is imported as part of an "article" as defined at 40 CFR 720.3( c) and in compliance with 40 

CFR 720.22(b)(1). 

(c) Automatic Sunset. If the Company has 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 

of the effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EV ALUA TION 

OF INFORMATION 

PROHIBITION 

The Company is prohibited from manufacturing, importing, processing, distributing in 

commerce, using, or disposing of the PMN substance in the United States, for any nonexempt 

commercial purpose, pending the development of information necessary for a reasoned evaluation 

of the human health and environmental effects of the substance, and the completion of EPA's 

review of, and regulatory action based on, that information, except in accordance with the 

conditions described in this Order. 

EPA SANITIZED Page 41 of 63
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TESTING 

(a) Section 8ee) Reporting. Reports ofinfonnation on the PMN substance which reasonably 

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

environment, which is required to be reported under EPA'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 be found in the 

reporting guide referenced at 56 Federal Register 28458 (June 20, 1991). 

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

Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. Environmental 

Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, of the following 

infonnation within 10 days of scheduling any study required to be perfonned pursuant to this 

Order, or within 15 days after the effective date of this Order, whichever is later: 

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

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

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

EPA may contact regarding the study; and, 

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

substance is subject to this Consent Order. 

EPA SANITIZED Page 42 of 63
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(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be performed 

pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards 

at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific 

community at the time the study is initiated. Before starting to conduct any study, the Company 

must obtain review of test protocols from EPA by submitting written protocols to EPA. EPA will 

respond to the Company within 4 weeks of receiving the written protocols. Any published test 

guidelines specified in this Order provide general guidance for development of test protocols, but 

are not themselves acceptable protocols. EPA review of a test protocol does not mean pre~ 

acceptance of test 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 Y L1"> 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 on November 4, 

20 II has been reviewed by EPA 

Amend sludge to soil; addition of to 

identifY degradation products, including 

unidentified peaks 

EPA SANITIZED Page 43 of 63
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( e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in 

a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of each 

study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential business 

information is involved), the final report of each study and all underlying data ("the report and 

data") to EPA no later than 14 weeks prior to exceeding the applicable production limit. The final 

report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted 

to EPA in accordance with the applicable "Reporting," "Data and Reporting," and "Test Report" 

subparagraphs in the applicable test guidelines. However, for purposes of this Consent Order, the 

word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the 

submission of such information is mandatory. EPA will not require the submission of raw data 

such as slides and laboratory notebooks unless EPA fmds, on the basis of professional judgment, 

that an adequate evaluation of the study carmot take place in the absence of these items. 

(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) of 

this Testing section if notified in writing by EPA that it is unnecessary to conduct that study. 

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

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

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

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

specified in paragraphs (b), (c), and (e)(l) and (2). The testing requirements may be modified, as 

EPA SANITIZED Page 44 of 63
-7-

necessary to permit a reasoned evaluation of the risks presented by the PMN substance, only by 

mutual consent of EPA and the Company. 

(h) EPA Determination of Invalid Data. 

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

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

a study are scientifically invalid, the Company is prohlbited from further manufacture and import 

of the PMN substance beyond the applicable production limit. 

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

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

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

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

and (e)(l) and (2). 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). If there is insufficient time for the Company 

to comply with subparagraph (e)(3), the Company may exceed the production limit and shall 

submit the report and data in triplicate to EPA within a reasonable period of time, all as specified 

by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in 

writing, within 6 weeks of receiving the Company's report and data. 

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

in subparagraph (h)(1), submit to EPA a written report refuting EPA's fmding. EPA will respond 

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

EPA SANITIZED Page 45 of 63
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(i) Company Determination of Invalid Data. 

(I) Except as described in subparagraph (i)(2), if the Company becomes aware that 

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

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

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

substance beyond the applicable production limit. 

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

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

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

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

report. EPA's written response may either: 

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

beyond the applicable production limit, or 

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

compliance with paragraphs (b), (c), and (e)(l) and (2). Ifthere is sufficient time to conduct or 

reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the 

production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph 

(e)(3). If there is insufficient time for the Company to comply with subparagraph (e)(3),the 

Company may exceed the production limit and shall submit the report and data in triplicate to EPA 

within a reasonable period of time, all as specified by EPA in the notice described in subparagraph 

(i)(2). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company's 

report and data, as to whether the Company may continue to manufacture and import beyond the 

applicable production limit. 

EPA SANITIZED Page 46 of 63
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(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 of this Order, the 

PMN substance will or may present an unreasonable risk of injury to human health or the 

enviromnent. EPA's notice may specify that the Company undertake certain actions concerning 

further testing, manufactnre,import, processing, distribution, use and/or disposal of the PMN 

substance to mitigate exposnres to or to better characterize the risks presented by the PMN 

substance. Within 2 weeks from receipt of such a notice, the Company must cease all 

manufacture, import, processing, distribution, use and disposal of the PMN substance, unless 

either: 

(2) within 2 weeks from receipt of the notice described in subparagraph (j)(I), the 

Company complies with such requirements as EPA's notice specifies; or 

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

Company submits to EPAa written report refuting EPA's finding and/or the appropriateness of 

any additional requirements imposed by EPA. The Company may continue to manufacture, 

import, process, distribute, use and dispose of the PMN substance in accordance with the tenus of 

this Order pending EPA's response to the Company's written report. EPA will respond to the 

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

receipt of EPA's written response, the Company shall comply with any requirements imposed by 

EPA's response or cease all manufactnre, import, processing, distribution, use and disposal of the 

PMN substance. 

EPA SANITIZED Page 47 of 63
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(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing 

section, the Company must continue to obey all the terms of this Consent Order until otherwise 

notified in writing by EPA. The Company may, based upon submitted test data or other relevant 

information, petition EPA to modifY or revoke provisions of this Consent Order pursuant to Part 

VI. of this Consent Order. 

MANUFACTURING 

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

of the PMN substance by auy other person. 

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

of a final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) 

ofTSCA unless the Company is notified on or before that day of an action in a Federal Court 

seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)(l) shall not 

expire until EPA notifies the Company in writing that all Federal Court actions involving the 

SNUR have been resolved and the validity of the SNUR affirmed. 

(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and 

subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each 

person whom it causes, encourages or suggests to manufacture or import the PMN substance of the 

existence of the SNUR. 

DISTRIBUTION 

Export Notice Requirement. No later thau the date of distribution, the Company shall notifY in 

writing any person to whom it distributes the PMN substance that, due to the issuance of this 

EPA SANITIZED Page 48 of 63
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Consent Order under section 5( e) of TSCA, the PMN substance is subj ect to the export notification 

requirements of TSCA 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 of the PMN substance, or (B) if the specific chemical identity is 

confidential, the generic chemical identity. 

III. RECORD KEEPING 

(a) Records. The Company shall maintain the following records until 5 years after the date they 

are created and shall make them available for inspection and copying by EPA in accordance with 

section 11 ofTSCA: 

(1) Exemptions. Records documenting that the PMN substance did in fact qualifY for any 

one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records 

must satisfy all the statutory and regulatory recordkeeping requirements applicable to the 

exemption being claimed by the Company. Any amounts or batches of the PMN substance 

eligible for the export only exemption in Section I, Paragraph (b )(1) of this Order are exempt from. 

all the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections 12(a)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance 

eligible for the research and development exemption in Section I, Paragraph (b)(2) of this Order 

are exempt from all the requirements in this Recordkeeping section, if the Company maintains, for 

5 years from the date of their creation, the records required by 40 CFR 720. 78(b). For any 

amounts or batches of the PMN substance claimed to be eligible for any other exemption described 

EPA SANITIZED Page 49 of 63
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in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating 

qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, 

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

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

and the corresponding dates of manufacture and.import; 

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

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

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

the substance sold or transferred on such date; 

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

use; 

(5) Records documenting compliance with the TSCA § 12(b) export notice requirement in 

the Distribution section of this Order; 

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

section of this Order, if applicable; and, 

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

substance is manufactured or imported. 

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

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

Company's customers. 

EPA SANITIZED Page 50 of 63
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(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 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 of Company facilities and conveyances 

associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the 

Company in advance to request information pertinent to the scheduling and conduct of such 

inspections. Such requests may be written or oral. The types of information that EPA may request 

include, but are not limited to, the following: 

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

subsequent 12 months; 

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

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

(iii) Current job titles or categories for workers who are involved in activities associated 

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

(iv) Existing exposure monitoring data for workers who are involved in activities 

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

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

EPA SANITIZED Page 51 of 63
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(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 of time, but in no event later than 30 days after receiving EPA's request. When requested 

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

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

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

to all of EPA's requests. 

(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the 

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of 

TSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope. This section sets forth the procedures by which the Company's rights and obligations 

under this Order may be transferred when the Company transfers its interests in the PMN 

substance, including the right to manufacture the PMN substance, to another person outside the 

Company (the "Successor in Interest"). 

(b) Relation of Transfer Date to Notice of Commencement (''NOC''). 

(1) Before NOC. If the transfer from the Company to the Successor in Interest is effective 

before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN 

EPA SANITIZED Page 52 of 63
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substance from the Company pursuantto 40 CFR nO.l 02, 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 of the PMN substance. 

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective 

after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and 

shall not be required to submit a new PMN to EPA. 

( c) Definitions. The following definitions apply to this Successor Liability section of the Order: 

(1) "Successor in Interest" means a person outside the Company who has acquired the 

Company's full interest in the rights to manufacture the PMN substance, including all ownership 

rights and legal liabilities, through a transfer document signed by the Company, as transferor, and 

the Successor in Interest, as transferee. The term excludes persons who acquire less than the full 

interest of the Company in the PMN substance, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substance. A Successor in 

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CFR nO.22(a)(3) and 40 CFR nO.3(z). 

(2) 'Transfer Document" means the legal instrument(s) used to convey the interests in the 

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

Successor in Interest. 

(d) Notices. 

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

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

EPA SANITIZED Page 53 of 63
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Order and the "Notice of Transfer" document which is incorporated by reference as Attachment B 

to this Order. 

(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the 

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

U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania 

Avenue, N.W., Washington, D.C. 20460. 

(3) Transfer Document. Copies of the Transfer Document must be maintained by the 

Successor in Interest at its principal place of business, and at all sites where the PMN substance is 

manufactured or imported. Copies of the Transfer Document must also be made available for 

inspection pursuant to Section ·11 ofTSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability for the PMN substance under the terms of this 

Order from the Company to the Successor in Interest. 

( e) Liability. 

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

the effective date of the transfer described above. 

(2) The Successor in Interest shall be liable for compliance with the requirements ofthis 

Order effective as of the date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made, during the time in which the Company manufactured, processed, used, distributed 

in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order. 

EPA SANITIZED Page 54 of 63
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(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section 

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

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

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

Successor in Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

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

health or environmental effects of, or human exposure to or environmental release of, the PMN 

substance, to modifY or revoke substantive provisions of this Order. The exposures and risks 

identified by EPA during its review of the PMN substance and the information· EPA determined to 

be necessary to evaluate those exposures and risks are described in the preamble to this Order. 

However, in determining whether to amend or revoke this Order, EPA will consider all relevant 

information available at the time the Agency m.akes that determination, including, where 

appropriate, any reassessment of the test data or other information that supports the findings in this 

Order, an examination of new test data or other information or analysis, and any other relevant 

information. 

EPA will issue a modification or revocation if EPA determines that the activities proposed 

therein will not present an unreasonable risk of injury to health or the environment and will not 

result in significant or substantial human exposure or substantial environmental release in the 

absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of 

the PMN substance. 

EPA SANITIZED Page 55 of 63
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In addition, the Company may petition EPA at any time to make other modifications to the 

language of this Order. EPA will issue such a modification if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 

EPA SANITIZED Page 56 of 63
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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 of this Order no 

later than 45 days before the eud ofthe review period pursuant to section 5(e)(1)(B) ofTSCA, and 

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

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

the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver 

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

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

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

Company (per section 14 of TSCA, 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 only the 

information contained within the brackets. 

fin M~:r,Director Chemical Control Division 

Date 

Office of Pollution Prevention and Toxics 

Name: 'j d 

EPA SANITIZED Page 57 of 63
ATTACHMENT A 

DEFINITIONS 

Note: The attached Order may not contain some of the terms defined below. 

"Chemical name" means the scientific designation of a chemical substance in accordance 

with the nomenclature system developed by the Chemical Abstracts Service's rules of 

nomenclature, or a name which will clearly identifY a chemical substance for the purpose of 

conducting a hazard evaluation. 

"Chemical protective clothing" means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substances of concern. Examples can include, but are not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

"Company" means the person or persons subject to this Order. 

"Commercial use" means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting contractor). 

"Common name". means any designation or identification such as code name, code number, 

trade name, brand name, or generic chemical name used to identifY a chemical substance other 

than by its chemical name. 

"Consumer" means a private individual who uses a chemical substance or any product 

containing the chemical substance in or around a permanent or temporary household or residence, 

during recreation, or for any personal use or enjoyment. 

"Consumer product" means a chemical substance that is directly, or as part of a mixture, 

sold or made available to consumers for their use in or around a permanent or temporary 

household or residence, in or around a school, or in recreation. 

"Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. . For purposes of this section, pipes or piping 

systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be 

containers. 

"Contract Manufacturer" means a person, outside the Company, who is authorized to 

manufacture and import the PMN substance under the conditions specified in Part II. of this 

Consent Order and in the Consent Order for Contract Manufacturer. 

"Identity" means any chemical or common name used to identifY a chemical substance or a 

mixture containing that substance. 

EPA SANITIZED Page 58 of 63
2 

"Immediate use." A chemical substance is for the "immediate use" of a person if it is under 

the control of, and used only by, the person who transferred it from a labeled container and will 

only be used by that person within the work shift in which it is transferred from the labeled 

container. 

"Inipervious." Chemical protective clothing is "impervious" to a chemical substance if the 

substance causes no chemical or mechanical degradation, permeation, or penetration of the 

chemical protective clothing under the conditions of, and the duration of, exposure. 

"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a 

chemical substance, regardless of physical state or concentration, through all intended operations 

. of manufacture, including the cleaning of equipment. 

"MSDS" means material safety data sheet, the written listing of data for the chemical 

substance. 

"NIOSH" means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health and Human Services. 

"Non-enclosed process" means any equipment system (such as an open-top reactor, storage 

tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise 

used where significant direct contact of the bulk chemical substance and the workplace air may 

occur. 

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

mixtures are manufactured, imported, or processed. 

"PMN substance" means the chemical substance described in the Premanufacture notice 

. submitted by the Company relevant to this Order. 

"Personal protective equipment" means any chemical protective clothing or device placed 

on the body to prevent contact with, and exposure to, an identified chemical substance or 

substances in the work area. Examples include, but are not limited to, chemical protective 

clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and 

various types of respirators. Barrier creams are not included in this definition. 

"Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

processing, including the cleaning of equipment. 

"Scientifically invalid" means any significant departure from the EPA-approved protocol 

or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

approval that prevents a reasoned evaluation of the health or enviromnental effects of the PMN 

substance. 

EPA SANITIZED Page 59 of 63
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 of injury to human health or the environment of the PMN substance . 

. "Sealed container" means a closed container that is physically and chemically suitable for 

long-term containment of the PMN substance, and from which there will be no human exposure to, 

nor enviroumental release of, the PMN substance during transport and storage. 

"Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

industrial, commercial, or consumer use. 

"Waters of the United States" has the meaning set forth in 40 CFR 122.2. 

"Work area" means a room or defined space in a workplace where the PMN substance is 

manufactured, processed, or used and where employees are present. 

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

work areas. 

EPA SANITIZED Page 60 of 63
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

PMNNmnber 

1. Transfer of Manufacture Rights. Effective on , the Company did sell or 

otherwise transfer to , ("Successor in Interest") the rights 

and liabilities associated with manufacture of the above-referenced chemical substance, which was 

the subject of a premanufacture notice ("PMN") and is governed by a Consent Order issued by the 

U.S. Environmental Protection Agency ("EPA") under the authority of §5( e) of the Toxic 

Substances Control Act ("TSCA," 15 U.S.C. §2604(e)). 

2. Assumption of Liability. The Successor in Interest hereby certifies that, as of the effective date 

of transfer, all actions or omissions governed by the applicable Consent Order limiting 

manufacture, processing, use, distribution in cOlumerce and disposal of the PMN substance, shall 

be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is 

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 

nO.22(a)(3). 

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

reasserts, 

_ relinquishes, or 

modifies 

all Confidential Business Infonnation ("CBI") claims made by the Company, pursuant to Section 

14 of TSCp ... 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 of Transfer. 

EPA SANITIZED Page 61 of 63
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 

EPA SANITIZED Page 62 of 63
3 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone 

EPA SANITIZED Page 63 of 63