·coNTAINS NO ;;Be 11{!0 (14 

r.n' f2A i\ /!b{/f 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) 

) 

) 

) 

) 

) 

Premanufacture Notice Number: 

[ ] 

'· 

,·~ I 

EPA SANITIZED 

) P- I I -0484 and P-11-0543 

) 

) 

) 

) 

) 

) 

) 

Consent Order, Consent Order for Contract Manufacturers, 

and Determinations Supporting the Consent Orders 
' . 

II 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Tem1s of the Order 

Ill. Contents of PMNs 

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 (defined by statute to include import). Processing, Qistribution in 

Commerce, Use, and Disposal Pending Submission and Evaluation of Information 

I II. 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 

Attachment C - Consent Order for Contract Manufacturer 

Attachment D- Key Elements of Biodegradation Testing of Fluorotelomer based Chemicals 
Ill 

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 notices ("PMNs") P-11-0484 and P-11-0543 ("the PMN 

substances") submitted by [ J 

("the Companies"), to take effect upon expiration of the PMN review period. The Companies 

submitted the PMNs to EPA pursuant to § 5(a)( l) ofTSCA 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 substances requires the Companies to: 

(I) ·Record and report [ ] impurities of the 

starting [ ] raw materials; 

(2) Not exceed the maximum established levels of [ 

] impurities; 
IV 

(3) Submit to EPA the results of certain triggered tests on the PMN substances before: 

(a) Tier l tests: manufacturing an aggregate of [ ] kilograms (kg) of P-11-0484 and 

] kg of P-11-0543 and within [ ] months from the Consent Order 

effective date. 

(b) Tier2 tests: [ ] after EPA specifies the testing for Tier 2. Production of P11-0484 and P-11-0543 can continue.at annual production volumes [ 

). 

(c) Tier 3 tests: ( ] after EPA specifies the testing for Tier 3. 

Production of P-11 ~0484 and P-11-0543 can continue at the annual production 

volumes [ ]. 

(4) Use the chemical substances Pll-0484 and Pll-0543 only as surfactants for [ 

] applications as described in the PMNs; 

(5) Not use the PMN substances in any consumer spray applications; 

(6) Distribute the PMN substances only to a person that agrees to follow the same restrictions 

(except for testing requirements listed in the Testing section of the Consent 

Order); 

(7) Comply with the Release to water provisions; 

(8) Incinerate all waste containing any of the PMN substances from manufacturing and 

processing (except for the PMN materials/waste that will be recycled and reused in 

manufacturing of the PMN substances or products made from the PMN substances) in an 

incinerator with combustion temperature of minimum I 000 degrees C and residence 
time of minimum 2 seconds; and 

(9) Maintain certain records. 

v 

A Consent Order for Contract Manufacturers is attached (Attachment C) to extend these 

requirements to the identified Contract Manufacturers. The Contract Manufacturers must keep 

records of quantities manufactured, but the Companies must submit to EPA all information 

required in the Consent Order. 

III. CONTENTS OF PMN 

By signing this Order, the Companies represent that they have carefully reviewed this 

document and agree that all information herein that is claimed as confidential by the Companies 

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

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

only the information contained within the brackets. 

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

Companies' identities; chemical identities; impurities; synonyms; production volumes; specific 

use; operation descriptions, including exposure and release estimates; and physical/chemical 

properties and, time frames. 

Chemical Identity: 

Specific:· 

P-11-0484: [ ] 

Generic: alkyl sulfate salt 
VI 

P-1 1-0543: [ 

Generic: polyfluorinatcd alkyl quaternary amine chloride 

Use: 

Specific: [ 

Generic: surfactants 

Estimated Maximum I 2-Month Production Volume during the first three vears of production: 

P-I 1-0484 - [ 

P- 1 1-0543 - [ 

] kg/year 

] kg/year 

Test Data Submitted with PMN: 

P-11 -0484 and P-11-0543: Acute ecotoxicity tests for fish , daplmia, and algae and, additional 

published literature [ 

substances. 

] on the environmental fate of the PMN 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

Based on the properties of the PMN substances and test data on analogous perfluorinated 

chemicals and potential pernuorinated degradation products such as perfluorooctanoic acid 

(PFOA), perfluorooctanesulfonate (PFOS), perfluorohexane sulfonate (PFHS), and 

I H, I H,2H,2H-perfluorooctanesulfonic acid (6-2 FTSA), EPA has identified human health and 

ecotoxicity concerns. 

Human Health Effects Summarv: 

Based on the analysis of the available test data for surfactant properties of analogous 
Vll 

substances and the degradation products of the PMN substances (P- 11-0484 and P-11-0543 ), 

EPA has human health concerns for irritation to skin, eyes, lungs, mucous membranes, and lung 

Toxicity, if inhaled. Toxicity studies on PFOA and PFOS indicate liver toxicity, blood toxicity, 

male reproductive toxicity, immunosuppression, and oncogenicity. These factors, taken 

together, raise concerns for potential adverse chronic effects in humans and wildlife. 

Ecotoxicity and Environmental Effects Summary: The PMN substances subject to this Order, 

P-11-0484 and P-11 -0543, and/or degradation products have been identified as having a potential 

concern for ecotoxicity. Based on submitted test data on for P-11-0484, EPA determined that 

toxicity to aquatic organisms may occur at concentrations that exceed the calculated 

concentrations of concern (COC) with the clu·onic COCs of2,800 and 1 ppb for 

P-11 ·0484 and P-11-0543, respectively, and acute COCs for P-11-0484 of 15,200 ppb and, for P11-0543, of2 ppb. EPA determined that P-11-0543 was acutely toxic to daphnids and algae and 

potentially chronically toxic based on the limited testing conducted to date. EPA determined that 

P-11-0484 is not acutely toxic and is not predicted to be chronically toxic. EPA believes that 

additional testing to characterize chronic fish and aquatic invertebrate ecotoxicity is needed. 

This testing will contribute to. defining the potential environmental hazard for the two PMN 

substances. 
VIII 

Ecotoxicity Profile of P-11-0484 and P-11-0543 based on Experimental Aquatic Toxicity Values 

(Adjusted for the Purity)*. 

Test Organ ism 

P-11 -0484 P-11-0543 

(mg/L) (mg/L) 

Fish 96 hour LCso 318 >30 

Daphnid 48 hour EC5o 76 6.6 

Green algae 72 hour EC50 264 < 0.009 

Fish ChV - -

Daph nid ChV - -

Green algae ChV < 28 < 0.009 

- = data not submitted 

* Based on additional information from the submitter, the purity of P-11-0484 and P-11-0543 

used in the toxicity testing was [ ], respectively. 

The abiotic and biotic degradation of P-11-0484 and P-11-0543 are not well understood. Only 

limited information exists on the identity of possible intermediates and stable end products. The 

published literature (including the published literature provided by the Companies) do not 

provide enough information to allow an understanding of the abiotic and biotic degradation 

pathways, identity of potentially toxicologically significant intermediates and end products, and 

their rates of formation and decline. Based on data for analogous perfluorinated chemicals, 

pernuorooctanoic acid (PFOA), perOuorooctanesulfonate (PFOS), and perOuorohexane sulfonate 

(PFHS), EPA has determined that the PMN substances and their degradation products will 

persist in the environment, could bioaccumulate or biomagnify, and could be toxic to people, 

wild mammals, and birds ("PBT"). The presumed perfluorinated degradants for the PMN 

substances include perfluorohexanoic acid (PFHxA). Biodegradation and photolysis tests of 

analogous substances to PFOA and PFOS indicate little or no biodegradation or photolysis of 
IX 

perfluoroalkyl compounds. 

Bioaccumulation concerns are based on concerns raised by the measured presence of 

certain perfluoroalkyl compounds with longer carbon chain length, including PFOA, PFOS, and 

PFHS in wildlife and in human blood samples. Potential risks to the environment are controlled 

by the Disposal and Release to Water restrictions are detailed in the Consent Order. 

ExP.osure and Environmental Release Summaries: 

Manufacturing will take place at the following [ ] sites: 

[ 

Waste (that contain the PMN substances) to the environment from manufacturing [ 

] and processing will be incinerated. Processing [ J will take place at [ 

and inhalation exposures are [ 

]. 

Environmental releases during use [ 

dispersive use are from use, disposal of [ 

to POTW or to surface water of [ 

]. Occupational dermal 

). Use as [ 

] ·which is considered a 

], and from disposal 

] . 
X 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

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

exposure to the PMN substances and their potential degradation products. EPA therefore 

concludes, pursuant to § S(e)(I)(A)(i) ofTSCA, that the infotmation available to the Agency is 

insufficient to permit a reasoned evaluation of the human health and environmental effects of the 

PMN substances and potential degradation products. 

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

uncontrolled manufacture (defined by statute to include import), processing, distribution in 

commerce, use, and disposal of the PMN substances, EPA has concluded, pursuant to § 

5(e)(I)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, processing, distribution in commerce, 

use, and disposal of the PMN substances may present an unreasonable risk of injury to human 

health and the environment. 

(c) In light of the estimated production volumes of, and human exposure to, the PMN substances 

and potential degradation products, EPA has further concluded, pursuant to § 5( e)( 1 )(A)(ii)(JI) of 

TSC/\. that the PMN substances will be produced in substantial quantities and may reasonably 

be anticipated to enter the environment in substantial quantities. and there may be significant (or 

substantial) human exposure to the substances and potential degradation products. 
XI 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH 

AND ENVIRONMENTAL EFFECTS 

. Triggered Testing. The Order prohibits the Companies from exceeding the specified 

production volumes unless the Companies submit the information described in the Testing 

section of this Order for P-11-0484 and P-11-0543 in accordance with the conditions specified in 

the Testing section. 

In addition, the Companies shall not manufacture or cause, encourage or suggest that a [ ] 

manufacturer manufacture the PMN substances unless a routine testing of the [ 

starting raw material for [ ] 

impurities by the Companies or as evidenced by a Ce11ificatc of Analysis from the raw material 

supplier, meets the established purity level as specified in Table I and Table 2 of this Order. 

Further, the Companies or th~ raw material supplier will annually test the [ 

starting raw material for [ ], including establishing calibration curves where 

the level of quantification desired is [ ]. 

Pended Testing. No consumer spray application of any of the PMN substances (P-11 -0484 and 

P-11-0543) is allowed until the following tests of both PMN compounds for health effects are 

conducted by the Companies, submitted to and evaluated by EPA, and the use in consumer spray 

application is approved by EPA: acute inhalation test, OPPTS 870.1300, and a 90-day inhalation 

study, OPPTS 870.3465, with a post-exposure observation period of up to 3 months and 

bronchoalveolar lavage nuid (BALF) analysis. EPA has determined that the test results could 

allow the Agency to consider consumer spray application of the PMN substances. 
XII 

The Order does not require submission of the above pended testing at any specified time 

or production volume. However, the Order's restrictions on manufacture (defined by statute to 

include import), processing, distribution in commerce, usc, 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 information. 

EPA expects that protocols would be submitted prior to any additional toxicological or 

ecological testing. Due to the limited water solubility of some of these substances and 

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

and other modifications will be agreed upon between EPA and the Companies. 
CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

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

proc~ssing, distribution in commerce, use and disposal of the following chemical substances: 

P-1 1-0484, [ 

[ 

submitted by [ 

], and P-11-0543, 

] ("the PMN substances"), 

J ("'the Companies"), 

to take effect upon expiration of the PMN review period, except to the extent that those activities 

are exempted by paragraph (b). 

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

PMN substances are exempt from the requirements of this Order (except the requirements in the 

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

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

of the following exemptions, and (2) such compliance is documented by appropriate 

recordkeeping as required in the Record keeping section of this Order. 

( 1) Export. Until the Companies begin commercial manufacture of the PMN substances 

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

processing or distribution in commerce of the PMN substances solely for export in accordance 
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with TSCA § 12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the 

Companies begin to manufacture the PMN substances for use in the United States, no further 

activity by the Companies involving the PMN substances is exempt as "solely for export" even if 

some amount of the PMN substances is later exp011ed. At this point, the requirements of this 

Order apply to all activities associated with the PMN substances while in the tenitory of the 

United States. Prior to leaving U.S. territory, even those quantities or batches of the PMN 

substances that are destined for export are subject to the terms of the Order, and count towards 

any production volume test triggers in the Testing section of this Order. 

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

manufacturing, processing, distribution in commerce, usc and disposal of the PMN substances in 

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

720.3(cc), and 40 CFR 720.36. The requirements of this Order also do not apply to 

manufacturing, processing, distribution in commerce, usc and disposal of the PMN substances 

when manufactured solely for non-commercial research and development per 40 CFR 720.30(i) 

and TSCA §S(i). 

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

when they are produced, without separate commercial intent, only as a "byproduct" as defined at 

40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). 

(4) o Separate Commercial Purpose. The requirements of this Order do not apply to 

the PMN substances when they are manufactured, pursuant to any of the exemptions in 40 CFR 

720.30(h), with no commercial purpose separate from the substances, mixture, or article of 

which it is a pa11. 

(5) Imported Articles. The requirements of this Order do not apply to the PMN 
- 3 -

substances when they are imported as pa11 of an "article" as defined at 40 CFR 720.3(c) and in 

compliance with 40 CFR 720.22(b)(l ). 

(c) Automatic Sunset. If the Companies have obtained for the PMN substances a Test Market 

Exemption ("TME") under TSCA §5(h)(l) and 40 CFR 720.3 8 or a Low Volume Exemption 

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

CFR 723.50(c)(l) 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, PROCESSING, 

DISTRJBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION OF INFORMATION 

PROHIBITION 

The Companies are prohibited from manufacturing (defined by statute to include import) 

the PMN substances in the United States, for any non-exempt commercial purpose, pending the 

development of information necessary for a reasoned evaluation of the human health and 

environmental effects of the substances, and the completion of EPA's review of, and regulatory 

action based on, that information, except in accordance with the conditions described in this 

Order. 
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CHEMICAL SYNTHESIS AND COMPOSITION 

(a) Restrictions. The Companies shall not manufacture or cause, encourage or suggest that a [ 

] manufacturer manufacture the PMN substances unless testing of the [ 

starting ra·w material by the Companies or as evidenced by a Certificate of Analysis from the raw 

material supplier, meets the established purity level as specified in Table I and Table 2 of this 

Order. If, a product that contained [ ] products was processed or 

manufactured in the equipment at the facility where the PMN substances are to be made, the 

Companies shall test the Initia lly Isolated Formulations of the PMN substances for the analytcs 

specified in Table 3 of this Order to con[jrm that cross-contamination from the manufacture of 

the product with [ ] has not occurred. Testing shall be conducted upon 

initial commencement of manufacture and at least annually thereafter, until one year after the 

date of the last manufacture or processing of a product that contains [ ] products at 

that facility. No testing of Initially Isolated Formulations of the PMN substances will be 

required if[ ] have not been previously manufactured or processed or were not 

manufactured or processed at the facility within one year of manufacturing or processing of the 

PMN substances. The Companies shall submit all analytical test protocols to EPA for approval 

prior to initiating testing. Protocols should be submitted to the OPPT Document Control Office 

(7407M), 1200 Pennsylvania Ave, N.W., Washington, DC 20460; Attention: Program Manager. 

New Chemicals Program, Chemical Control Division. EPA will respond to the Companies 

within [ ] weeks of recei ving the vvritten protocols. The Companies shall record the levels of 

impurities [ ] associated with the 

PMN substances manufactured by the Companies and/or the Contract Manufacturer, as 
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specified below. The Companies shall record analytes present in the [ ], at each 

manufacturing facility using this raw material (as sho~n in Table I). Further, the Companies 

will also annually record the analyte [ ] present in the 

) starting raw material (as shown in Table 2). The Companies shall make its 

best effort to minimize these impurities. If any new manufacturing facilities are added, or the 

manufacturing process is significantly altered, then the PMN substances must be tested at 

commencement of these actions and annually thereafter. 

(b) Reporting. The Companies shall test representative samples of the Initially Isolated 

Formulations of the PMN substances manufactured by the Companies and/or the Contract 

Manufacturer to determine compliance with the requirements in paragraph (a). The Companies 

shall .test the Initially Isolated Formulations of the PMN substances at each manufacturing 

facility both (I) at the initial commencement of non-exempt manufacture of the PMN substances 

at that facility, and (2) at least annually thereafter during every year in which the PMN 

' substances are manufactured at that facil ity. If any new manufacturing facility is added, or if the 

process of manufacture of the PMN substances or any intermediate thereof is significantl y 

altered, then the Initially Isolated Formulation of the PMN substances must be tested at 

commencement of these actions and annually thereafter, as set forth above. If the PMN 

substances are imported, the Companies shall obtain from the foreign manufacturer written 

documentation to certify that representati ve samples of the imported form of the PMN 

subst~nces have been tested, consistent with the requirements of this paragraph (b) and 

determined to comply with the requirements of paragraph (a). 

The Companies shall rep.o11 the above testing to EPA at initial commencement of 
- 6-

manufacture and again if any nevv manufacturing facility is added or if the process of 

manufacture of the PMN substances or any intermediate thereof is significantly altered. The 

Companies shall continue to report these impurity levels to EPA annually. This is consistent 

with the cuncnt annual reporting cycle [ 

]. In addition to the reporting for the Initially Isolated Formulations of the 

PMN substances itself, the Companies shall, for the [ ] starting raw material, 

annually report (I) the average values and the range of values, including outlying data, for the 

routine testing for the analytes specified in Table I, and (2) the results of the annual testing for 

the analyte specified in Table 2. 

TABLE I: Chemicals to be Routinely Tested in [ ] Starting Raw Material 

Analyte CAS Number Limit in [ ] 

[ ] [ ] [ ] minimum 

[ ] [ J [ 1 

[ ] [ ] 

TABLE 2: Chemicals to be Tested at least Annually in [ ] Starting Raw Material 

Analyte I CAS Number Limit in [ 
- 7-

TABLE 3: Chemicals to be Tested in the Initially Isolated Formulations of the PMN Substance 

Estimated Maximum in Initially 

Analyte CAS Number Isolated Formulations of the PMN 

Substance 

[ ] [ ] [ ] [ ] [ ] 

[ ] [ ] [ ) 

TESTING 

(a) Section 8(e) Reporting. Reports of information on the PMN substances which reasonably 

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

the environment and which is required to be reported under TSCA section 8(e) shall reference 

the appropriate PMN identification numbers for these substances and contain a statement that the 

substances are subject to this Consent Order. Additional information regarding section 8( e) 

reporting requirements can be found at www.epa.gov/opptltsca8e. 

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

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

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

Washington, D.C. 20460, of the following information within I 0 days of scheduling any study 

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

Order, whichever is later: 

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

The vvritten notice should be submitted to EPA as follows: 

Postal Mail Address 

U.S. Environmental Protection Agency 

GLP Section Chief- Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227 A) 

Office of Enforcement and Compliance Assurance 

1200 Pennsylvania !\venue, . W. 

Washington, DC 20460 

Courier Delivery Address 

U.S. Environmental Protection Agency 

GLP Section Chief- Pesticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227 A) 

Office ofEnforcement and Compliance Assurance 

Room 7117B 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20004 
- 9-

(c) Good Laboratory Practice Standards and Test Protocols. Each study performed to address 

the risks identified in this Order must be conducted according to TSCA Good Laboratory 

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

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

any study that will use a modified version of a published guideline, the Companies must submit 

written test protocols to EPA for review (submission of written test protocols is optional when 

using unmodified published test guidelines) . Protocols must be submitted as a support 

document for the PMNs using the procedures set out in 40 CFR 720.40. EPA will respond to the 

Companies within 4 weeks of receiving the written protocols. EPA review of a test protocol 

does not mean pre-acceptance of test results. 

(d) Triggered Testing Requirements. The Companies are prohibited from manufacturing 

(defined by the statute to include import) the PMN substances beyond the following time 

allowances or aggregate manufacture volumes ("the production limits"), unless the Companies 

either: 

(I) conducts the following studies on the PMN substances and submits all final reports 

and underlying data in accordance with the conditions specified in this Testing section, or 

(2) submit other relevant information (including test data conducted using alternate 

guidelines) to meet these requirements and EPA determines that this other information satisfies 

the testing requirements. 

. The Companies shall submit quarterly progress reports and provide documentation on the 

progress of the studies via EPA Central Data Exchange (COX). The Companies and EPA agree 
- I 0 -

to consult by conference call to discuss the quarterly reports, upon EPA's request. Should there 

be unforeseen events outside the control of the Companies or the contract laboratories that cause 

the studies to be delayed, the Companies will promptly notify EPA and, if EPA agrees that the 

events were unforeseen and outside the control of the Compani es or the contract laboratories, 

EPA will consider extending the test triggers. 

The following triggered testing on PMN substances, P-11-0484 and P-11-0543, is required to be 

submitted to EPA before: 

(a) Tier I tests: manufacturing an aggregate of [ ] kilograms (kg) of P-11-0484 

and [ ] kg of P-11-0543 and within [ ] months from the Consent Order 

cffecti ve date. 

(b) Tier 2 tests: [ ] after EPA specifies the testing for Tier 2. Production of 

P-11-0484 and P-11-0543 can continue at annual production volumes [ 

]. 

(c) Tier 3 tests: [ ] after EPA specifies the testing for Tier 3. Production of 

P-11-0484 and P-11 -0543 can continue at annual production volumes [ 

] . 

Tier 1 tests (conducted on P-11-484 and P-11-543) (NOTE: Protocols for all Tier I tests have 

been submitted to and reviewed by EPA). 

Biodegradation test (Modified Semi Continuous Activated Sludge, 

SCAS, OPPTS Guideline 835.5045 or OECD 302A, 

or modified Zahn-Wellens method, OECD 3028, 

with analysis for degradation products- see EPA 
- 1 1 -

general guidance presented in Attachment 2, Key 

Elements of Biodegradation Testing of 

Fluorotelomer Based Chemicals. The Company 

must look for the C6 and C7 possible degradants 

specified in Table 4 below). Mass balance should. be 

attempted, to the best of the laboratory's ability, to 

achieve 70 - 130% over the course of the study. 

TABLE 4: PMN Substances and Potential Metabolites/Degraclants for which 

Analysis during Tier 1 and Tier 2 Fate Testing is Required 

Analyte 

[ 

[ 

[ 

[ 

[ 

[ ] 

[ 

[ ] 

Abiotic Fate tests: 

Hydrolysis as a function of pH and temperature 

UV visible light absorption 

Direct Photolysis, if wavelengths greater than 

290 nm are absorbed in the previous test 

Indirect Photolysis Screening Test 

] 

] 

] 

CAS Number 

[ ] 

[ ] 

[ ] 

J [ ] 

] r ] 

[ ] 

] [ ] 

[ ] 

(OPPTS 835.2130, OECD Ill) 

(OPPTS 830.7050) 

(OPPTS 835.22 1 0) 

(OPPTS 835.5270) 
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Tier 2 

Fate tests(conducted on P-11-484 and P-11-543): 

Anaerobic biodegradabi I i ty of 

organic compounds in digested sludge 

with analysis of the degradation 

products from Table 4 

Ecotoxicity tests (conducted on P-11-0484 and P-11-0543): 

Fish early life stage toxicity test 

Daphnid chronic toxicity test 

(OECD 31 1/0PPTS 835.3420) 

OPPTS 850.1400 

OPPTS 850.1300 

Ecotoxicity tests (conducted on the degradants of interest identified by EPA after EPA review of 

the Tier I biodegradation test): 

Fish 96-hr LC50 

Flow-through method, analytical 

measurement of test substances, 

mean, measured test concentrations. 

Acute Daphnia 

Flow-through method, analytical 

measurement of test substances, 

mean, measured test concentrations. 

Algae 

Static method, analytical measurement 

of test substances, mean, measured test 

concentrations. 

OPPTS 850.1075 

OPPTS 850.10 I 0 

OPPTS 850.5400 

After the Tier I testing is completed, it will be reviewed and analyzed by EPA. 

Depending on the results of the review, additional testing will be required as described in Tier 3 

below. 

Tier 3 (conducted on either: (a) P-11-0543 and P- 11-0484 or (b) the degradants of interest from 

Table 4 that arc identified by EPA based on the Tier I data) 

Ecotoxicity test: 

Avian Reproduction in bobwhite quail or mallard ducks 
for PMN compound and any PBT metabolites 

identified by the fate testing. 

Human Health hazard tests: 

Pharmacokinetics study in rats and mice 

Combined repeated dose toxicity study 

with developmental/reproduction screening 

oral1:oute, species to be determined by the 

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test (870.3650), oral route, species to be 

determined by the results of the pharmacokinetics 

studies with the following modifications -

increase parental sample size to 20; 

duration of study extended until pups have 

reached sexual maturation; parental males 

dosed for I 0 weeks prior to mating; 

dosing of parental animals continues 

through lactation followed by direct dosing 

of pups until they reach sexual maturation; 

pup body weight recorded on lactation 

days 0, 4, 7, 14, and 21 and then at weekly 

intervals; time of sexual maturation (i.e. vaginal 

opening and preputial separation recorded); 

litter size can be standardized to 4 pups/litter 

on lactation day 4 (optional); at weaning 

one pup/sex/litter can be randomly selected 

to foflow until sexual maturation 

EPA Data Review 

(OPPTS 850.2300, OECD 206) 

(OPPTS 870. 7485) 

(OPPTS 870.3650- modified, 

OECD 42 1 - modified) 

EPA will evaluate the data especially in light of the degradants formed factoring in how quickly 

and qualitatively how much ofthe degradant is formed. In addition, EPA will consider the 

persistence, potential bioaccumulation and toxicity of the PMN substance and its degradants, as 

well as the potential for exposure and release to the environment. EPA is concerned with both 

potenti al toxicity to humans and terrestrial and aquatic species. 
- I 4-

(e) Test Reports. The Companies shall : (I) 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 the final report of each study (with an additional sanitized copy, if 

confidential business information is involved) and all underlying data ("the report and data'') to 

EPA prior to exceeding the applicable production limit. The final report and data must be 

submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. 

The final report shall contain the contents specified in 40 CFR 792. I 85. Underlying data shall be 

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

"Test Repot1" subparagraphs in the applicable test guidelines. However, for purposes of this 

Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to 

make clear that the submission of such information. is mandatory. EPA will require the 

submission of raw data such as slides and laboratory notebooks only if EPA finds, on the basis of 

professional judgment, that an adequate evaluation of the study cannot take place in the absence 

of these items. 

EPA will review the submitted test data within 6 weeks. If EPA does not meet this 

deadline, the Companies may request a modification of the testing deadlines and allowable 

production volumes. 

(f) Testing Waivers. The Companies are 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. 
- 15 -

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

the Companies may continue to manufacture (defined by statute to include import) the PMN 

substances beyond the applicable production limit. To seek relief from any other restrictions of 

this Order, the Companies may make a second attempt to obtain unequivocal data by 

reconducting the study under the conditions specified in paragraphs (b), (c), and (e) (except that 

the study may be submitted after reaching the applicable production limit). The testing 

requirements may be modified, as necessary to permit a reasoned evaluation of the risks 

presented by the PMN substances, only by mutual consent of EPA and the Companies. 

(h) EPA Determination ofinvalid Data. 

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

test report and data, the Companies receive written notice that EPA finds that the data generated 

by a study are scientifically invalid, the Companies are prohibited from further manufacture 

(defined by the statute to include import) of the PMN substances beyond the applicable 

production limit. 

(2) The Companies may continue to manufacture (defined by the statute to include 

import) the PMN substances beyond the applicable production limit only if so notified, in 

writing, by EPA in response to the Companies' compliance with either of the following 

subparagraphs (h)(2)(i) or (h)(2)(ii). 

(i) If there is sufficient time to reconduct the study in compliance with paragraphs 

(b), (c), and (e) before exceeding the production limit specified in paragraph (d), the Companies 

may reconduct the study. If there is insufficient time to reconduct the study in compliance with 

paragraphs (b), (c), and (e) before exceeding the production limit specified in paragraph (d), the 
- 16-

Companies may exceed the production limit, but must otherwise comply with paragraphs (b), (c), 

and (e), and shall submit the report and data to EPA within a reasonable period of time, all as 

specified by EPA in the notice descri bed in subparagraph (h)( I). EPA will respond to the 

Companies. in writing, within 6 weeks of receiving the Companies' report and data. 

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

described in subparagraph (h)( I), submit to EPA a \vritten report refuting EPA's finding. EPA 

will respond to the Companies, in writing, within 4 \Vccks of receiving the Companies' report. 

(i) Company Determination of Invalid Data. 

(I) Except as described in subparagraph (i)(2), if the Companies become aware that 

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

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

(c) and (e), the Companies remain prohibited from further manufacture (defined by the statute to 

include import) of the PMN substances beyond the applicable production limit. 

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

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

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

EPA wi ll notify the Companies of its response, in writing, within 4 weeks of receiving the 

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

(i) allow the Companies to continue to manufacture (defined by the statute to 

include import) the PMN substances beyond the applicable production limit, or 

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

compliance with paragraphs (b), (c), and (e), if there is sufficient time to conduct or reconduct 
- 17 -

the study and submit the report and data to EPA before exceeding the production limit specified 

in paragraph (d). If there is insufficient time for the Companies to comply with paragraphs (b), 

(c), and (e) before exceeding the production limit specified in paragraph (d), the Companies may 

exceed the production limit, but must otherwise comply with paragraphs (b), (c), and (e), and 

shall submit the report and data 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 Companies, in 

writing, within 6 weeks of receiving the Companies' report and data, as to whether the 

Companies may continue to manufacture (defined by statute to include import) beyond the 

applicable production limit. 

U) Unreasonable Risk. 

EPA may notify the Companies in writing that EPA finds that the data generated by a 

study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, 

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

environment. EPA's notice may specify that the Companies unde11ake certain actions 

concerning further testing, manufacture (defined by statute to include import), processing, 

distribution, use and/or disposal of the PMN substances to mitigate exposures to or to better 

characterize the risks presented by the PMN substances. Within 2 weeks from receipt of such a 

notice, the Companies must cease all manufacture (defined by statute to include import), 

processing, distribution, use and disposal of the PMN substances, unless either: 

(A) within 2 weeks from receipt of the EPA notice, the Companies comply with 

such requirements as EPA's notice specifies; or 
- 18 -

(B) vvithin 4 weeks from receipt of the EPA notice, the Companies submit to 

EPA a written report refuting EPA's finding and/or the appropriateness of any additional 

requirements imposed by EPA. The Companies may continue to manufacture (defined by statute 

to include import), process, distribute, use and dispose of the PMN substances in accordance 

with the terms of this Order pending EPA's response to the Companies' written report. EPA will 

respond to the Companies, in writing, within 4 weeks of receiving the Companies' repol1. 

Within 2 weeks of receipt of EPA's written response, the Companies shall comply with any 

requirements imposed by EPA's response or cease all manufacture (defined by statute to include 

import) , processing, distribution, use and disposal of the PMN substances. 

(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing 

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

notified in writing by EPA. The Companies 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)( I) Prohibition. The Companies shall not cause, encourage, or suggest the manufacture 

(defined by statute to include import) of the PMN substances by any other person, except as 

described in paragraph (b). 

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

promulgation of a final significant new use rule ("SNUR") governing the PMN substances under 
- 19-

section S(a)(2) of TSCA unless the Companies are notified on or before that day of an action in a 

Federal Court seeking judicial review of the SNUR. If the Companies are so notified, 

subparagraph (a)( I) shall not expire until EPA notifies the Companies 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 substances 

and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Companies shall 

notify each person whom it causes, encourages or suggests to manufacture (defined by statute to 

include import) the PMN substances of the existence of the SNUR. Such notification mu~t be in 

writing and must specifically include all limitations contained in the SNUR which are defined as 

significant new uses, and which would invoke significant new use notification to ~PA for the 

PMN substances. s'uch notice must also reference the publication of the SNUR for the PMN 

substances in either the Federal Register or the Code of Federal Regulations. 

(4) Subparagraph (a)(2) shall not negate the effects of any fully executed Consent Order 

for Contract Manufacturer entered into under paragraph (b)(2). 

(b) Contract Manufacturer. Notwithstanding paragraph (a), the Companies may cause the 

Contract Manufacturer(s) identified in the PMN and listed in the Preamble of this Order to 

manufacture (defined by statute to include import) the PMN substances according to the 

following conditions (after this Order has been signed, the Companies may petition EPA 

pursuant to Section VI of this Order to include additional Contract Manufacturers): 

(I) The Contact Manufacturer must be under contract to the Companies to manufacture 

(defined by statute to include import) the PMN substances solely for the Companies. The 
- 20-

contract must specify the identity of the PMN substances, the total quantities to be manufactured, 

and the basic technology to be used for manufacturing. 

(2) The Companies shall obtain from each Contract Manufacturer a signed copy of the 

Consent Order for Contract Manufacturer (attached to this Order as Attachment C) and submit 

the copy to EPA along with the name, address, and telephone number of a responsible official of 

the Contract Manufacturer. The Consent Order should be submitted to the OPPT Document 

Control Office (7407M), 1200 Pennsylvania Ave. N.W., Washington, DC 20460; Attention: 

Program Manager, New Chemicals Program, Chemical Control Division. The Contract 

rvlanufacturer or Company must receive a fully executed copy of the Consent Order for the 

Contract Manufacturer from EPA before the Contract Manufacturer may begin manufacture. 

(3) If at any time, the Companies learn that the Contract Manufacturer has failed to 

comply with any of the conditions specified in the Consent Order for Contract Manufacturer. the 

Companies shall immediately cease to cause the Contract Manufacturer to manufacture the PMN 

substances, unless the Contract Manufacturer is in compliance with a SNUR for the PMN 

substances, or unless the Companies are able to document each of the f~ ll owing: 

(i) That the Companies have, within 5 working days, notified the Contract 

Manufacturer in wt'iting that the Contract Manufacturer has failed to comply with the conditions 

specified in the Consent Order for Contract Manufacturer. 

(ii) That, within 15 working days of notifying the Contract Manufacturer of the. 

noncompliance, the Companies received from the Contract Manufacturer, in writing, a statement 

of assurance that the Contract Manufacturer is a\.vare of the terms of the Consent Order for 

Contract Manufacturer and will comply with those terms. 
- 2 1 -

(iii) If, after receiving a statement of assurance from the Contract Manufacturer 

under subparagraph (B) of this Section, the Companies have notice or knowledge that the 

Contract Manufacturer has failed to comply with any of the conditions specified in the Consent 

Order for Contract Manufacturer, the Companies shall immediately cease to cause the Contract 

Manufacturer to manufacture the PMN substances, shall noti fy EPA of the failur~ to comply, and 

shall resume causing the Contract Manufacturer to manufacture the PMN substances only upon 

writt\!n notification from the Agency. 

c) The Companies and their Contract Manufacturer(s) shall not manufacture the PMN 

substances P-11-0484 and P-11-0543 beyond the annual manufacture (including importation) 

volumes specified in paragraph (d) under "Testing." 

USE 

The Companies shall: 

(a) Use the chemical substances P-11 ~0484 and P~ 11-0543 only as surfactants for 

[ ]; and 

(b) Not use the PMN substances P-1 I -0484 and P-11- 0543 for consumer spray 

applications. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Companies shall 
- 22-

notify in writing any person to whom it distributes the PMN substances that, due to the issuance 

of this Consent Order under section 5( e) ofTSCA, the PMN substances are subject to the export 

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

shall contain, in the form in vvhich it appears in this Consent Order, the following information: 

(I) the PMN number. and (2) either (A) the specific chemical identity of the PMN substances, or 

(B) if the specific chemical identity is confidential, the generic chemical identity. 

(b) Distribution Requirements. Except as provided in paragraph (c), the Companies shall 

distribute the PivfN substances outside the Companies, other than for disposal, only to a person 

who has agreed in writing prior to the date of distribution, to: 

(I) Notify in writing any person to whom it distributes the PMN substances that, due to 

the issuance of this Consent Order under section 5( e) of TSCA, the PMN substances are subject 

to the expot1 notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. 

Such notice shall contain, in the form in which it appears in this Consent Order, the following 

information: (I) the PMN number, and (2) either (A) the specific chemical identity of the PMN 

substances, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(2) Comply with the same environmental release restrictions, required of the Companies 

in the Disposal and Release to Water sections of this Order. 

(3) Use the PMN substances P-11-0484 and P-11-0543 only as surfactants for 

] applications as described in the PMNs, and not use the PMN substances P-I 1-

0484 and P-11- 0543 for consumer spray applications. 

(c) Temporary Transport and Storage. Notwithstanding paragraph (b), the Companies may 
- 23-

distribute the PMN substances outside the Companies for temporary transport and storage in 

sealed containers provided the following three conditions are met: 

(I) Subsequent to any such exempt temporary transport or storage of sealed containers, 

the PJ'vfN substances may be distributed only to the Companies or a person who has given the 

Companies the written agreement required by paragraph (b). 

(2) Any human exposure or environmental release resulting from opening the sealed 

containers and removing or washing out the PMN substances may occur only while the PMN 

substances is in the possession and control of the Companies or a person who has given the 

Companies the written agreement required by paragraph (b). 

· (3) A statement ofthe health hazards(s) and precautionary measure(s), if any, identified 

by the Companies for the PMN substance; the identity by which the PMN substance may be 

commonly recognized; a statement of the environmental hazard(s) and precautionary measure(s), 

if any, identified by the Companies for the PJ'vfN substance; a statement of exposure and 

precautionary measure(s), if any, identified by the Companies for the PMN substance; and the 

name and address of the manufacturer or a responsible party who can provide additional 

information on the substance for hazard evaluation and any appropriate emergency procedures. 

The label shall not conflict with the requirements of the Hazardous Materials Transportation Act 

( 18 U .S.C. 1801 et. seq.) and regulations issued under that Act by the Department of 

Transportation. 

(d) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of 

the PMN substances, the Companies obtain knowledge that a recipient of the substances has 

failed to comply with any of the conditions specified in paragraph (b) of this Distribution section 
-24-

or, after paragraph (b)(2) expires in accordance with subparagraph (e)( I), has engaged in a 

significant new usc of the PMN substances (as defined in 40 CFR Pa11 721, Subpart E) without 

submitting a significant new use notice to EPA, the Companies shall cease supplying the 

substances to that recipient, unless the Companies are able to document each of the following: 

(I) That the Companies have, within 5 working days, notified the recipient in writing 

that the recipient has failed to comply with any of the conditions specified in paragraph (b) of 

this Distribution section, or has engaged in a significant new use of the PMN substances without 

submitting a significant new usc notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, the 

Companies received from the recipient, in writing, a statement of assurance that the recipient is 

aware of the terms of paragraph (b) of this Distribution section and will comply with those terms, 

or is aware of the terms of the significant new use rule for the PMN substances and will not 

engage in a significant new use without submitting a significant new use notice to EPA. 

(3) If, after receiving a statement of assurance from a recipient under subparagraph 

(d)(2) of this Distribution section, the Companies obtain knowledge that the recipient has failed 

to comply with any of the conditions specified in paragraph (b) of this Distribution section. or 

has engaged in a significant new use of the PMN substances without submitting a significant 

new use notice to EPA, the Companies shall cease supplying the PMN substances to that 

recipient, shall notify EPA ofthe failure to comply, and shall resume supplying the PMN 

substances to that recipient only upon written notification from the Agency. 

(e) Sunset Following SNUR. (I) Paragraph (b)(2) of this Distribution section shall expire 75 

days af1er promulgation of a final SNUR for the PMN substances under section 5(a)(2) of TSCA. 
- 25-

unless the Companies are notified on or before that day of an action in a Federal Com1 seeking 

judicial review of the SNUR. If the Companies are so notified, paragraph (b)(2) of this 

Distribution section shall not expire until EPA notifies the Companies in writing that all Federal 

Court actions involving the SNUR have been resolved and the validity of the SNUR affirmed. 

(2) When EPA promulgates a final SNUR for the PMN substances and paragraph (b)(2) of this 

Distribution section expires in accordance with subparagraph (e)(! ), the Companies shall notify 

each person to whom it distributes the PMN substances of the existence of the SNUR. Such 

notification must be in writing and must specifically include all limitations contained in the 

SNUR which are defined as significant new uses, and which would invoke significant new use 

notification to EPA for the PMN substances. Such notice must also re fe rence the publication of 

the SNUR for these PMN substances in either the Federal Register or the Code of Federal 

Regulations. After promulgation cif a SNUR and expiration of subparagraph (b )(2), such notice 

may substitute for the written agreement required in the introductory clause of paragraph (b); so 

that, ifthe Companies provide such notice to the persons to whom it distributes the PMN 

substances, then the Companies are not required to obtain from such persons the written 

agreement specified in paragraph (b). 

DISPOSAL 

The Companies shall dispose of the PMN substances and any waste containing the PMN 

substances from manufacturing and processing only as follows: incinerate the waste in an 

incinerator operating at the temperature of at least I 000 degrees C and a residence time of 

minimum of2 seconds. Any tank or vessel washings, residues from transport vessels or tanks, 
- 26-

and similar materials that arc captured and retained in the normal course of manufacturing and 

processing for re-use in manufacturing of the PMN substances or products made from the 

PMN substances are exempt from this method of disposal. 

This provision does not supersede or preempt any applicable federal, state, and local laws 

and regulations ifthose laws arc more stringent than the requirements below. 

RELEASE TO WATER 

This provision does not supersede or preempt any applicable federal, state, and local laws 

and regulations. (Those other laws may be more stringent than the requirements below.) 

The Companies are prohibited from any predictable or purposeful release of the PMN 

substances, or any manufacturing or processing waste streams containing any of the PMN 

substances to the waters of the United ~ta es, except [ 

] . 

RISK NOTIFICATION 

(a) If as a result of the test data required under the terms ofthis Order, the Companies become 

aware that the PMN substances may present a risk of injury to human health or the environment 

(or is so notified by EPA), the Companies must incorporate this new information, and any 
- 27-

information on methods for protecting against such risk, into a Material Safety Data Sheet 

("MSDS") for the PMN substances, as described in 40 CFR section 721.72(c), within 90 days 

from the time the Companies become aware of the new information. If the PMN substances are 

not being manufactured, proc~ssed, or used in the Companies' workplace, the Companies must 

add the new information to an MSDS before the PMN substances are reintroduced into the 

workplace. 

(c) the Companies must ensure that persons who will receive the PMN substances from 

the Companies (including any Contract Manufacturer(s) (as described in paragraph 

(b) of the Manufacturing section ofthis Order), or who have received the PMN 

substances from the Companies within 5 years from the date the Companies become 

aware of the new information described in paragraph (a) of this section, are provided 

an MSDS containing the information required under paragraph (a) within 90 days 

from the time the Companies become aware of the new information. 

III. RECORDKEEPING 

(a) Records. The Companies 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 II ofTSCA: 

(I) Exemptions. Records documenting that the PMN substances 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 
- 28-

exemption being claimed by the Companies. Any amounts or batches of the PMN substances 

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

from all the requirements in this Recordkeeping section, if the Companies maintain, for 5 years 

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

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

substances 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 Companies 

maintain, 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 substances claimed to be eligible for any other 

exemption described in Section I, Paragraph (b) of this Order, the Companies shall keep records 

demonstrating qualification for that exemption as well as the records specified in paragraphs (3) 

and (4) below, but is exempt from the other recordkeeping requirements in this Recordkeeping 

section; 

(2) Records documenting compliance with the Chemical Synthesis and Composition; 

(3) Records documenting the manufacture (defined by statute to include import) volume 

of the PMN substances and the corresponding dates of manufacture; 

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

address, if different) of al l persons outside the site of manufacture to whom the Companies 

directly sell or transfers the PMN substances, the date of each sale or transfer, and the quantity of 

the substances sold or transferred on such date; 

(5) Records documenting the address of all sites of manufacture, processing, and use; 

(6) Records documenting compliance with any applicable manufacturing, processing, 

use, disposal and distribution restrictions in the Manufacturing, Processing, Use, and Distribution 
- 29-

sections of this Order, including distributees' written agreement to comply with the Distribution 

section of this Order; 

(7) Records documenting compliance with any applicable disposal requirements under 

the Disposal section of this Order, including method of disposal, location of disposal sites, dates 

of disposal, and volume of PMN substances disposed. Where the estimated disposal volume is 

not known to the Companies and is not reasonably ascertainable by the Companies, the 

Companies must maintain other records which demonstrate establishment and implementation of 

a program that ensures compliance with any applicable disposal requirements; 

(8) Records documenting establishment and implementation of procedures that ensure 

compliance with any applicable water discharge limitation in the Release to Water section of this 

Order; 

(9) Copies of any Transfer documents and notices required by the Successor Liability 

section of this Order, if applicable; and, 

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

substances is manufactured (defined by statute to include import), processed, or used. 

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

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

Companies' customers. 

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

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

"collection of information" unless this Order displays .a currently valid control number fr:om the 
- 30-

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

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

currently valid OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

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

may occasionally conduct on-site compliance inspections of Company facilities and conveyances 

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

the Companies in advance to request information pertinent to the sche9uling 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 vvhen the PivfN substances will be in production within the 

subsequent 12 months; 

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

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

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

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

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

associated with the PMN substances and may reasonably be exposed to the PMN substances that 

arc collected during the manufacture or processing of the PMN substances; 

(5) Records required by the Recordkeeping section of this Order; and/or, 
- 31 -

(6) Any other information reasonably related to determining compliance with this Order 

or conducting an inspection for that purpose. 

(b) Company's Response. The Companies 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 Companies' response shall be in writing. To the extent the information is 

known to or reasonably asce11ainable by the Companies at the time of the request, the 

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

detailed answers to all of EPA's requests. 

(d) Confidential Business Information. Any Confidential Business Information ("CBI") 

that the Companies submit to EPA pursuant to paragraph (b) shall be protected in 

accordance with §14 ofTSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope. This section sets forth the procedures by which the Compani es' rights and 

obligations under this Order may be transferred when the Companies transfer its interests in the 

PMN substances, including the right to manufacture the PMN substances, to another person 

outside the Compani~s (the "Successor in Interest"). 

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). 
- 32 -

(I) Before NOC. If the transfer from the Companies to the Successor in Interest is 

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

the PMN subs ance~ from the Companies pursuant to 40 CFR 720.102, the Successor in Interest 

must submit a new PMN to EPA and comply fully with Section 5(a)(l) ofTSCA and 40 CFR 

part 720 before commencing manufacture (defined by statute to include import) of the PMN 

substances. 

(2) After NOC. If the transfer from the Companies 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 of the Order: 

(I) "Successor in Interest" means a person outside the Companies who has acquired the 

Companies' full interest in the rights to manufacture the PMN substances, including all 

ownership rights and legal liabilities, through a transfer document signed by the Companies, as 

transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire 

less than the full interest of the Companies in the PMN substances, such as a licensee who has 

acquired a limited license to the patent or manufacturing rights associated with the PMN 

substances. A Successor in Interest must be incorporated, licensed, or doing business in the 

United States in accordance with 40 CFR 720.22(a)(3) and 40 CFR 720.3(z). 

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

the PMN substances, including the right to manufacture the PMN substances. from the 

Companies to the Successor in Interest. 
- 33-

(d) Notices. 

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

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

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

8 to this Order. 

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

Companies 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 substances 

is manufactured (defined by statute to include import). Copies of the Transfer Document must 

also be made available for inspection pursuant to Section II ofTSCA, must state the effective 

date of transfer, and must contain provisions which expressly transfer liability for the PMN 

substances under the terms of this Order from the Companies to the Successor in Interest. 

(e) Liability. 

(I) The Companies shall be liable for compliance vvith the requirements of this Order 

until the effective date of the tran sf~r described above. 

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

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 Companies after the effective date of the transfer for actions 
- 34-

taken, or omissions made, during the time in which the Companies manufactured, processed, 

used, distributed in commerce, or disposed of the PMN substances pursuant to the terms of this 

Consent Order. 

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing 

section of this Consent Order requires the Companies to submit test data to EPA at a specified 

production volume ("test trigger'·), the aggregate volume of the PMN substances manufactured 

(defined by statute to include import) by the Companies 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 Companies 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 substances, to modify or revoke substantive provisions of this Order. The exposures and 

risks identified by EPA during its review of the PMN substances and the information EPA 

determined to be necessary to evaluate those exposures and risks are described in the preamble to 

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

all relevant information available at the time the Agency makes that determination, including, 

where appropriate, any reassessment of the test data or other information that supports the 

findings in this Order, an examination of new test data or other information or analysis, and any 

other relevant information. 
- 35 -

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 substances. 

In addition, the Companies 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. 
- 36-

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry of this Order, the Companies waive their rights to file 

objections t~ this Order pursuant to section S(e)(J)(C) ofTSCA, to receive service of this Order 

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

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

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

Companies as to the facts or conclusions underlying the Agency's determinations in this 

proceeding. This waiver does not affect any other rights that the Companies may have under 

TSCA. 

(b) CBI Brackets. By signing this Order, the Companies represent that it have carefully 

reviewed this document and hereby agrees that all information herein that is claimed as 

confidential by the Companies (per section 14 of TSCA, 40 CFR Pa11 720 Subpart E, and 40 

CFR Part 2) is correctly identified within brackets and that any information that is not bracketed 

is not claimed as confidential. To make this document available for public viewing, EPA will 

remove only the information contained within the brackets. 

)Jpo/11__ 

Oat 

Maria J. Doa, h D., Director 

Chemical Control Division 

Office of Pollution Prevention and Taxies· 

[~- Name: [ ·-·- ··-· Title: [ 

Company: ] 

J 

] 
_LO ~~()/;4 L J 

Date/ ' --·· Name: [ ] 

Title: [ ] 

Company: [ ] 
ATTACHMENT A 

DEFINITIONS 

Note: The all ached 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. 

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

"Commercial use" means the use of a chemical substances 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 Companies, who is authorized to 

manufacture (defined by statute to include import) the PMN substance under the conditions 

specified in Part II of this Consent Order and in the Consent Order for Contract Manufacturer. 

"Final Formulation of the PMN substance" means the formulated dispersion of the PMN 

substance in the form in which it is sold to customers outside the Companies or transferred to a 

different business unit within the Companies. The term does not include intermediate dilutions 

of the PMN substance that are intended only for use within the Companies for further dilution · 

prior to sale. 

"ldentity" means any chemical or common name used to identify a chemical substance or 

a mixture containing that substance. 
A-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 \VOrk shift in which it is transferred from the labeled 

container. 

"Initially Isolated Formulations of the PMN substance" means a common intermediate 

PMN formulation, as it exists when first produced and isolated after the polymer manufacturing 

process, that can be further processed or repackaged at the direction of the Companies to result 

ultimately in one or more final formulations of the PMN substance. 

"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. 

"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 substances and the 

workplace air may occur. 

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

mixtures are manufactured (defined by statute to include import) or processed. 

"PMN substance" means the chemical substance described in the ?remanufacture notice 

submitted by the Companies relevant to this Order. 

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

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

of processing, including the cleaning of equipment. 

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

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

Agency approval that prevents a reasoned evaluation of the health or environmental effects of the 

PMN substance. 

"Scientifically equivocal data" means data which, although developed in apparent 

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. 
A-3 

"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 neither human 

exposure to nor environmental release of the PMN-substance during transport and storage. 

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

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

industrial, commercial, or consumer use. 

"Waters of the United States" has the meaning set f011h in 40 CFR 122.2. 

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

work areas. 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(c) CONSENT ORDER 

PMN Number 

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

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

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

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

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

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

2. Assumption of Liability. The Successor in Interest hereby certi ties that, as of the effective 

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

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

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

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

720.22(a)(3 ). 

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

__ reasserts, 

_ relinquishes, or 

modifies 

all Confidential Business Information ("CBI") claims made by the Companies, pursuant to 

Section 14 ofTSCA and 40 CFR part 2, for the PMN substances(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 ofTransfer. Information which has been previously disclosed to the public (e.g., a 

chemical identity that was not claimed as CBI by the original submitter) would not subsequently 

be eligible for confidential treatment under this Notice of Transfer. 
B-2 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

(continued) 

Company (Transferor) PMN Number 

Signature .of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Atithorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 
B-3 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone