UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTIONPREVENTION AND TOXICS

REGULATION OF NEW CHEMICAL SUBSTANCES PENDING DEVELOPMENT OF INFORMATION

Inthe matter of: 

### ) PremanufactureNotice Number: ) ) ) ) ) 

### [ l ) Pll-0483, Pll-0487, Pll-0527, Pll-0528, ) Pll-0529, Pll-0530, Pll-0532, Pll-0533, ) and Pll-0534 ) ) ) 

## EPA SANITIZED ) ) )

Consent Order, Consent Order for Contract Manufacturer, and Determinations Supporting Consent Orders11 TABLE OF CONTENTS Preamble I. Introduction II. Sunnnary ofTerms ofthe Order III. Contents ofPMNs IV. EPA's Assessment ofExposure and Risk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health and Enviromnental Effects
Consent Order I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Recordkeeping IV. Requests for Pre-Inspection Information V. Successor LiabilityUpon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. ·Effect ofConsent Order Attaclnnent A - Definitions Attaclnnent B- Notice ofTransfer ofConsent Order Attaclnnent C - Consent Order for Contract Manufacturer Attaclnnent D- Key Elements ofBiodegradationTesting ofFluorotelomerbased Chemicals111



## PREAMBLE I. INTRODUCTION Underthe authority of§ 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e)), the Environmental Protection Agency ("EPA" or "theAgency'') issues the attached Order, regardingpremanufacture notices ("PMNs") P11-0483, P11-0487, P11-0527, Pll-0528, Pll-0529, Pll-0530, P11-0532, P11-0533, and Pll-0534 ("the PMN substances") submittedby [ 

## l ("the Companies"), to take effect upon expiration ofthe PMNreview period. The Companies submitted the PMNs to EPA pursuant to§ 5(a)(1) ofTSCA and 40 CFRPart 720. Under § 15 ofTSCA, it is unlawful for anyperson to fail orrefuseto comply with any provision of§ 5 orany order issued under § 5. Violators maybe subject to various penalties and to both criminal and civil liabilitypursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substances subject to an Order issued under§ 5 of TSCA, such as this one, are subject to the § 12(b) export notice requirement.



### II. SUMMARY OF TERMS OF THE ORDER The Consent Order for the PMN substances requires the Companies to: (I) Record and report [ ] impurities ofthe starting [ ] raw materials;IV (2) Not exceed themaximum established levels of [ ] impl}rities; (3) Submit to EPA the results ofcertain triggered tests on the PMN substance P11-0483 and triggered fate test data on the PMN substance P11-0530 before manufacturing or importing an aggregate of[ ] kilograms (kg) (Tier 1 ), [ ] years [ ] months after the Company signed this Consent Order (Tier 2), [ ] kg (Tier 3) and, [ ] kg (Tier4) ofthe PMN substances Pl1-0487, Pll-0530, Pll-0533, and Pll-0534combined; (4) Limit the annual production volume for the PMN substances, P11-0487, Pll-0530, Pll-0533, and Pll-0534 to [ ] kg each; (5) Use the PMN substances P11-0483, Pll-0527, Pll-0528, P11-0529, and Pll-0532 as

chemical intermediates as described inthe PMNs (to manufacture Pll-0487, Pll-0530, Pll-0533, and Pll-0534) and to manufacture [ ]; (6) Use the chemical substances Pll-0487, Pll-0530, Pll-0533 andPll-0534 only
as surfactants for [ 

### Japplications as described in the PMNs; (7) Not use the PMN substances in any consumer spray applications; (8) Distribute the PMN substances onlyto a person that agrees to follow the same restrictions (except for testing requirements listed in the Testing section ofthe Consent Order); (9) Complywith the Release to waterprovisions; (10) Incinerate all waste containing any ofthe PMN substances from manufacturing and processing (except for the PMNmaterials/waste that will be recycled and reused in

### v manufacturing ofthe PMN substances orproducts made from the PMN substances) in
an incinerator with combustion temperature ofminimum 1000 degrees C and residence time ofminimum 2 seconds; and (11) Maintain certain records.
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 ofquantities manufactured, butthe Companies must submit to EPA all information required inthe Consent Order.



### III. CONTENTS OF PMN By signing this Order, the Companies represent that theyhave carefullyreviewed this document and agree that all information herein that is claimed as confidential bythe Companies is correctly identified withinbrackets and that any information that is notbracketed 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; andphysical/chemical properties.
Chemical Identity:

### Specific: P-11-0483- [ P-11-0487 - [ ], 

### P-11-0527

- [ ], 

### P-11-0528 - [ ], 

### P-11-0529- [ 

## l P-11-0530 - [

P-11-0532- [ ], 

### P-11-0533 - [ ], and P-11-0534 - [

Generic: P-11-0483, alkyl thiol; P-11-0487, alkyl polyamide; P-11-0527, substituted fluoroalkane; P-11-0528, fluorinated thio1; ],

],



### P-11-0529, fluorinated monomer; P-11-0530, fluoropolyacrylamide; P-11-0532, polyfluoroalkylamine;
. P-11-0533, non-ionic fluorosurfactant; and P-11-0534, anionic fluorosurfactant. VI

].

### Use: Specific: P-11-0483- [ P-11-0487- [ P-11-0527- [ P-11-0528 - [ P-11-0529 - [ P-11-0530 - [ P-11-0532 - [ P-11- 0533 and P-11-0534- [ ]. Vll



### ]. ]. ]. ]. 

## l ]. ].



### Generic: P11-0487, P11-0530, P11-0533 and P11-0534- surfactants P11-0483, P11-0527, Pl1-0528, .P11-0529, and P11-0532- chemical intermediates Maximum 12-MonthProduction Volume: (kg/year) P-11-0483-[ ] P-11-0487- [ ] P-11- 0527- [ ] P-11-0528-[ ] P-11- 0529- [ ] P-11- 0530- [ ] p -11- 0532- [ ] P-11- 0533 - [ ] P-11- 0534 - [ ]



### IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK Based on the properties ofthe PMN substances and test data on analogous perfluorinated chemicals and potential perfluorinated degradation products such as perfluorooctanoic acidVlll 

### (PFOA), perftnOlOOctanesulfonate (PFOS), perfluorohexane sulfonate (PFHS), and 1H,1H,2H,2H-perfluoroocanesulfonic acid, EPA has identified human health and ecotoxicity
concerns. Human HealthEffects Sununary: Based on the analysis ofthe available test data for surfactant properties ofanalogous substances and the degradation products ofthe PMN substances (Pll- 0483, Pll-0487, Pll-0527, Pll-0528, Pll-0529, Pll-0530, Pll-0532, Pll-0533, and Pll-0534), EPA has human health concerns for irritation to skin, eyes, lungs, mucous membranes, and lung toxicity ifinhaled. Toxicity studies on PFOA and PFOS indicate liver toxicity, blood toxicity, male reproductive toxicity, inununosuppression, and oncogenicity. These factors, taken together, raise
concerns for potential adverse chronic effects inhumans and wildlife. Ecotoxicity and Environmental Effects Summary: All PMN substances subject to this Order, Pll- 0483, Pll-0487, Pll-0527, Pll-0528, Pll-0529, Pll-0530, Pll-0532, Pll-0533, Pll-0534 and/or degradation products have been identified as having a potential concern for ecotoxicity. Based onEcoSAR analysis oftest data on analogous substances, EPApredicts toxicity to aquatic organisms may occur at concentrations that exceed the identified concentrations ofconcern (COC). Based on data for analogous perfluorinated chemicals, perfluorooctanoic acid (PFOA), perfluorooctanesulfonate (PFOS), and perfluorohexane sulfonate (PFHS), EPA has determined that the PMN substances and their degradation products will persistin the environment, could bioaccumulate orbiomagnify, and could be toxic to people, wild mammals, and birds("PBT"). The presumed perfluorinated degradants for the PMN substances include perfluorohexanoic acid (PFHxA). Biodegradationand.photolysis testsix ofanalogous substances to PFOA and PFOS indicate little orno biodegradation orphotolysis of perfluoroalkyl compounds.
Bioaccumulationconcerns are based on concerns raised bytbe measured presence ofcertain perfluoroalkyl compounds witb longer carbon chain length, including PFOA, PFOS, and PFHS in wildlife and in human blood samples. Potential risks to the environment are controlled bytbe Disposal and Release to Water restrictions are detailed intbe Consent Order.
Exposure and Environmental Release Summaries: Manufacturing will take place at the following [ [



## l Waste to tbe environment from manufacturing [ PMN substances) will be incinerated. Processing [

and inhalation exposures are [
]. Environmental releases during use [ dispersive use are from disposal of[ disposal to POTW orto.surfacecwater of [ ] sites:

] and processing (tbat containtbe ] will take place at [ ]. Occupational dermal ]. Use as [

] which is considered ], and fromX

V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine thepotential for human health and environmental effects from exposure to the PMN substances and theirpotential degradation products. EPA therefore concludes, pursuant to§ 5(e)(l)(A)(i) ofTSCA, that the information available to the Agency is insufficientto permit a reasoned evaluation ofthe humanhealth and environmental effects ofthe PMN substances and potential degradation products.
(b) Inlight ofthe potential risK ofhumanhealth and environmental effects posed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances, EPA has concluded, pursuantto § 5( e)(1)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances maypresent an unreasonable risk ofinjury to human health and the environment.
(c) Irt light ofthe estimated production volume of, andhuman exposure to, the PMN substances and potential degradationproducts, EPA has further concluded, pursuantto § 5( e)(l)(A)(ii)(II) of TSCA, that the PMN substances will be produced in substantial quantities and mayreasonably be anticipated to enter the environment in substantial quantities, and there maybe significant (or substantial) human exposure to the substances andpotential degradationproducts.XI

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND ENVIRONMENTAL EFFECTS 

### Triggered Testing. The Orderprohlbits the Companies from exceedingthe specified production volumes unless the Companies submit the information described in the Testing section ofthis Order for P!!-0483 and Pll-0530 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 ofthe [ ] starting raw material for [ ] 

### impurities by the Companies oras evidenced by a Certificate ofAnalysis from the raw material supplier, meets the established purity level as specified in Table I and Table 2 ofthls Order. Further, the Companies or the rawmaterial supplier will annually test the [ 

## l starting rawmaterial for [ ], including establishlng calibration curves where the level ofquantification desired is [ 

### ]. If, at any point, the PMN substances [ ] that are related to the PMN substances regulated underthis Consent Orderbut are regulated separately through a [ ] are withdrawn by the Companies from PMNreview, Pll-0487, Pll-0530, Pll-0533, and Pll-0534 will be subject to all testing (triggered) required inthe [
]. In 

### addition, Pll-0530 will be subject to all tests required for Pll-0483 in the case of [ ] withdrawal. The testing triggers will be calculated at the time ofthe withdrawal, starting from the. beginningofthe.manufacturing.Xll

Pended Testing. The following pended testing onthe PMN substances P11-0487, P11-0527, Pll-0528, Pll-0529, Pll-0532, P11-0533, and Pll-0534, would be necessary to evaluate the environmental effects: All the triggered tests listed inthe Testing section ofthis Consent Order for Pll-0483 and P11-0530 plus aerobic and anaerobic transformation in soil tests (OECD 307), phototransformation ofchemicals (Draft OECD Guideline on soil surfaces-2 soils, Jan. 2002), simulationtest-aerobic sewage treatment (activated sludge units) (OECD 303A), and aerobic and anaerobic transformation in aquatic sediment systems (OECD 308).
P11-0530 will have the following tests pended: phototransformation ofchemicals (Draft OECD Guideline on soil surfaces-2 soils, Jan. 2002), simulation test-aerobic sewage treatment (activated sludge units) (OECD 303A), and aerobic and anaerobic transforniation in aquatic sediment systems (OECD 308). No consumer spray application ofany ofthe PMN substances (P11-0487, P11-0530, P11-0533, and P11-0534) is allowed until the following tests ofall PMNcompounds for health effects are conducted bythe Companies, submitted to and evaluated byEPA, and the
use inconsumer spray applicationis approved byEPA: acute inhalation test, OPPTS 870.1300, and a 90-day inhalation study, OPPTS 870.3465, with a post-exposure observation period ofup to 3 months and bronchoalveolar lavage fluid (BALF) analysis. EPA has determined that the test results could allow the Agency to consider consumer spray application ofthe PMN substances.Xlll The Order does notrequire submission ofthe above pended testing at any specified time
orproduction volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance will remain in effect until the Order is modified orrevoked by EPAbased on submission ofthat or otherrelevant information. EPA expects that protocols would be submittedprior to any additional toxicological or ecological testing. Due to the limited water solubility ofsome ofthese substances and consequent analytical difficulties, some modification ofthe protocols may be necessary. These and other modifications will be agreed upon betweenEPA and the Companies.

## CONSENT ORDER I. SCOPE OF APPLICABILITY AND EXEMPTIONS (a) Scope. The requirements ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe following chemical substances; P-11-0483 - [ P-11-0487 - (

P-11-0530 - ( ], P-11-0527 - [ ], P-11-0528- [ ], P-11-0529- [

], P-11-0532 - [ ], P-11-0533 - [ ], and P-11-0534- [
], ],

],-2- submitted by [ ] ("the Companies"),to take effect upon expiration ofthe PMNreviewperiod, except to the extent that those activities
are exemptedbyparagraph (b). (b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances are exempt from the requirements ofthis Order (except the requirements inthe Recordkeeping and SuccessorLiability Upon Transfer OfConsent Order sections) only to the extent that (I) these activities are conductedin full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required inthe Recordkeeping section ofthis Order. (!) Export. Until the Companies begin commercialmanufacture ofthe PMN substances for use inthe United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe PMN substances solely for exportin accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFRPart 707. However, once the Companies beginto manufacture the PMN substances for use inthe United States, no further activity bythe Companies involving the PMN substances is exempt as "solely for export" even if
some amount ofthe PMN substances is later exported. Atthis point, the requirements ofthis Order apply to all activities associated with the PMN substances while inthe territory ofthe United States. Priorto leaving U.S. territory, even those quantities orbatches ofthe PMN substances that are destined for export are subject to the terms ofthe Order, and count towards any production volume test triggers in the Testing section ofthis Order. (2) Research & Development ("R&D"). The requirements ofthis Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances in small quantities solely for research and development in accordance withTSCA §5(h)(3), 40 CFR- 3- 720.3(cc), and 40 CFR 720.36. The requirements ofthis Order also do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances when manufactured solely for non-commercial research and development per40 CFR 720.30(i) and TSCA §5(i). (3) Byproducts. The requirements ofthis Order do not apply to the PMN substances when they are produced, without separate commercial intent, only as a "byproduct" as defmed at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). ( 4) No Separate Connnercial Purpose. The requirements ofthis Order do not apply to the PMN substances whenthey are manufactured, pursuant to any ofthe exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substances, mixture, or article of which itis a part. (5) Imported Articles. The requirements ofthis Order do not apply to the PMN substances when they are imported as part ofan "article" as defined at 40 CFR 720.3( c) and in compliance with 40 CFR 720.22(b)(l).
(c) Automatic Sunset. Ifthe Companies have obtained for the PMN substances a Test Market Exemption ("TME") under TSCA §5(h)(l) and 40 CFR 720.38 ora LowVolume Exemption ("LYE") orLowRelease and Exposure Exemption ("LoREX") under TSCA §5(h)(4) and 40 CFR 723.50(c)(1) and (2) respectively, any such exemptionis automatically rendered null and void as ofthe effective date ofthis Consent Order.



### II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION-4-

PROHIBITION 

### The**Comp~ies** 

### are prohibited from manufacturing the PMN substances in the United States, for any non-exempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substances, and the completion ofEPA'sreview of, and regulatory action based on, that information, except in accordance with the conditions described in this Order.

CHEMICAL SYNTHESIS AND COMPOSITION 

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

## Jmanufacturer manufacture the PMN substances unless testing ofthe [ ] starting rawmaterial by the Companies or as evidenced by a Certificate ofAnalysis from the raw material supplier, meets the established purity level as specified inTable 1 and Table 2 ofthis Order. If, a product that contained [ ] products was processed or manufactured inthe equipment at the facility where the PMN substances are to be made, the Companies shall test the Initially Isolated Formulations ofthe PMN substances for the analytes specified in Table 3 ofthis Order to 

### confirm that cross-contamination from the manufacture ofthe product with [ 

## Jhas not occurred. Testing shall be conducted upon initial commencement ofmanufacture and at least annually thereafter, until one year afterthe date ofthe last manufacture or processing ofa product that contains [ ] products at that facility. No testing ofinitially Isolated Formulations ofthe PMN substimces will be required if [ ] have not been previously manufactured orprocessed or

### - 5-
were not manufactured orprocessed atthe facility withln one year ofmanufacturing or processing ofthe PMN substances. The Companies shall submit all testprotocols to EPA for approval prior to initiating testing. Protocols shouldbe submitted to the OPPTDocument Control Office (7407M), 1200 Pennsylvania Ave, N.W., Washlngton, DC 20460; Attention: Program Manager, New Chemicals Program, Chemical Control Division. EPAwill respondto the Companies withln [ 

## Jofreceiving the written protocols. Absent a response from EPA within the [ ] window, the Companies are permitted to rely on its protocols until an EPAresponse is received. The Companies shall record the levels ofimpurities [ ] associated with the PMN substances manufactured by the Companies and/orthe Contract Manufacturer, as specified below. The Companies shall record analytes present in the [ ], at each manufacturing facility using tills raw material (as shownin Table l). Further, the Companies will also annually record the analyte [ ] present inthe [ ] starting raw material (as shown in Table 2). The Companies shall make its best effort to minimize these impurities. Ifany new manufacturing facilities are added, orthe manufacturing process is significantly altered, then the PMN substances mustbetested at commencement ofthese actions and annually thereafter.
(b) Reporting. The Companies shall test representative samples ofthe Initially Isolated Formulations ofthe PMN substances manufactured orimported by the Companies and/orthe Contract Manufacturerto determine compliance withthe requirements in paragraph (a). The Companies shall test the Initially Isolated Formulations ofthe PMN substances at each manufacturing facility both (1) atthe initial commencement ofnon-exempt manufacture ofthe PMN substances atthat facility, and (2) atleast annually thereafter during every year in which

### -6- the PMN substances are manufactured at that facility orimported. Ifany newmanufacturing facility is added, or ifthe process ofmanufacture ofthe PMN substances orany intermediate thereofis significantly altered, thenthe Initially Isolated Formulation ofthe PMN substances must be tested at commencement ofthese 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 representative samples ofthe imported form ofthe PMN substances have been tested, consistent withthe requirements ofthis paragraph (b) and determined to comply with the requirements ofparagraph (a). The Companies shall report the above testing to EPA atinitial commencement of manufacture or import and again ifany newmanufacturing facility is added or ifthe process of manufacture ofthe PMN substances or any intermediate thereofis significantly altered. the Companies shall continue to report these impurity levels to EPA annually. This is consistent with the current annual reporting cycle [ ]. In addition to the reporting for the Initially Isolated Formulations ofthe PMN substances itself, the Companies shall, for the [ ] starting rawmaterial, annually report (1) the average values and the range ofvalues, including outlying data, for the routine testing for the analytes specified inTable 1, and (2) the results ofthe annual testing forthe analyte specified in Table 2. TABLE 1: Chemicals to be Routinely Tested in [ ] Starting RawMaterial Analyte CAS Number Limit in[] [] [ 

### l []minimum [] [ 

### l [J [] 

### [ 

### l- 7-
TABLE 2: Chemicals to be Tested at least Annually in [ ] Starting Raw Material Analyte Limitin[] [] TABLE 3: Chemicals to be Tested inthe Initially IsolatedFormulations ofthe PMN Substance EstimatedMaximum inInitially Analyte CAS Number Isolated Formulations ofthe PMN Substance [] [ 

## l [] [] 

### [ 

## l [] [ 

## l []

TESTING (a) Section 8(e) Reporting. Reports ofinformation on the PMN substances which reasonably supports the conclusion that the PMN substances presents a substantial risk ofinjury to health or the enviromnent and which is required to be reported under TSCAsection 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/oppt/tsca8e.
(b) Notice ofStudy Scheduling. The Companies shall notify, in writing, the EPA Monitoring Assistance and Media Programs Division (2227A), Office ofEnforcement and Compliance Assurance, U.S. Enviromnental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study

### - 8- required to be performed pursuant to this Order, or within 15 days afterthe effective date ofthis Order, whichever is later: (1) The date when the study is scheduledto commence; (2) The name and address ofthe laboratory which will conduct the study; (3) The name and telephone number ofthe persons at the Companies or the laboratory whom EPA may contact regarding the study; and, ( 4) The appropriate PMN identification number for each substances and a statement that the substances are subject to this Consent Order.
(c) Good Laboratory Practice Standards andTest Protocols. Each study required to be performed pursuant to the triggered testing requirements ofthis Order mustbe conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodologies generally accepted inthe relevant scientific community at the time the study is initiated. Before starting to conduct any toxicity study, the Companies must obtain approval of test protocols from EPA by submitting written: protocols. Protocols mustbe submitted to the OPPT DocumentControl 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 [] ofreceiving the writtenprotocols. Absent a response from EPA within the [] window, the Companies are permitted to rely on its protocol until an EPA response is received. Published test gnidelines specified in paragraph (d) provide general guidance for development oftest protocols, but are not themselves acceptable protocols. EPA approval ofa test protocol does not mean pre-acceptance oftest results.- 9- (d) Triggered Testing Requirements. The Companies are prohibited from manufacturing or importing the PMN substances beyond the following time allowances or aggregate manufacture and import volumes ("the production limits"), unless the Companies either: (1) conducts the following studies on the PMN substances and submits all final reports and underlying data in accordance with the conditions specified inthis Testing section, or (2) submits other relevant information (including test data conducted using alternate guidelines) to meet these requirements and EPAdetermines that this other information satisfies the testing requirements. The following triggered testing onthe PMN substance P11-0483 (Tiers 1, 3, and 4) and Tier 2 and Tier 4 triggered fate tests on the PMN substance P11-0530 will be required inthe Consent Order 14 weeks before manufacturing or importing an aggregate of[ ] kilograms (Tier 1 ), [] years []months (Tier 2), []kilograms (Tier 3), and []kilograms (Tier 4) of the PMN substances [ 

### Jcombined. Tier 1 tests (for Pll-0483 chemical substance) [ ] kg Pharmacokinetics study inrats and mice Combined repeated dose toxicity study with developmental/reproduction screening test, oral route, species to be determined bythe results ofthe pharmacokinetics studies with modifications.
Tier 2 tests (for P11-0530 chemical substance)
Soil biodegradation study (OPPTS 870.7485) (OPPTS 870.3650 modified,

OECD421 modified)

[] years [] months afterthe date the Company signed this Consent Order (OECD 307)Tier 

### 3 (for Pll-0483 chemical substance) [ Fish 96-hr LC50 Flow-through method, analytical measurement oftest substance, mean, measured test concentrations. Acute Daphnia Flow-through method, analytical measurement oftest substance, mean, measured test concentrations. Algae Static method, analytical measurement oftest substance, mean, measured test concentrations. Tier 4 test [ 

## l kg - 10-

Triggered testing (for Pll-0483 chemical substance)

## l kg

Avian Reproduction inbobwhite quail or mallard ducks (OPPTS 850.1075)

(OPPTS 850.1010)

(OPPTS 850.5400)

for PMN compound. (OPPTS 850.2300, OECD 206) Triggered testing for Pll-0530 chemical substance Hydrolysis as a function ofpH and temperature (OPPTS 835.2130, OECD 111) UV visible light absorption (OPPTS 830.7050) Direct Photolysis, ifwavelengths greaterthan 290 nm are absorbed inthe previous test (OPPTS 835.2210)
Indirect Photolysis Screening Test Anaerobic biodegradability of organic compounds in digested sludge Degradation test (OPPTS 835.05270) (OECD 311/835.3420) (Modified Semi Continuous Activated Sludge, SCAS, OPPTS Guideline 835.5045 or OECD 302A, or modified Zahn-Wellens method, OECD 302B, with analysis for degradation products

- see EPA general guidance presented inAttachment D, Key ·- 11 - 

### Elements ofBiodegradation Testing of Fluorotelomer Based Chemicals. The Companies must analyze for the C6 and C7 possible degradants specified in Table 4 below) Table 4. Potential PBT Enviromnental Metabolites/degradants to be analyzed. Analyte CAS Number [] [] [] 

## [ l [] 

## [ l [] [ 

### l [] [ 

## l [] [ 

### l [] 

## [ l [] 

### [ 

## l
(e) Test Reports. The Companies shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPA the results ofany interim phase of each study; and (3) submit, intriplicate (with an additional sanitized copy, if confidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA prior to exceedingthe production limit. The fmal report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting," "Data and Reporting," and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the submission ofsuch inforination is mandatory. EPA will require the submission ohawdata ·- 12- such as slides aud laboratory notebooks only ifEPA fmds, onthe basis ofprofessionaljudgment, that au adequate evaluation ofthe study carmot take place in the absence ofthese items. (f) Testing Waivers. The Companies are notrequired to conduct a study specifiedinparagraph (d) ofthis Testing section ifnotified in writing by EPAthat it is unnecessary to conduct that study because for example, alternative information would satisfy the requirements.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Companies may continue to manufacture aud import the PMN substances beyond the applicable production limit. To seek relieffrom any otherrestrictions ofthis Order, the Companies may make a second attempt to obtainunequivocal data by reconducting the study underthe conditions specified inparagraphs (b), (c), aud (e)(l) aud (e)(2). The testing requirements maybe modified, as necessary to permit a reasoned evaluation ofthe risks presentedbythe PMN substances, onlybymutual consent ofEP A aud the Companies.
(h) EPADetermination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report aud 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 aud import ofthe PMN substances beyondthe applicable production limit. (2) The Companies may continue to manufacture aud import the PMN substances beyondthe applicable production limit only ifso notified, in writing, byEPA inresponse to the Companies' compliance with either .ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii).

### - 13- (i) The Companies mayreconduct the study in compliance withparagraphs (b), (c), and (e)(l) and (2). Ifthere is sufficient time to reconductthe study and submittbe report and data to EPA before exceeding tbe production limits as required by subparagraph ( e)(3), the Companies shall comply witb subparagraph (e)(3). Iftbere is insufficient time for the Companies to comply with subparagraph ( e)(3), the Companies may exceedthe production limit and shall submit the report and dataintriplicate to EPA within a reasonable period oftime, all as specified by EPA intbe notice described in subparagraph (h)(l). EPA will respond to tbe Companies, in writing, witbin 6 weeks ofreceiving the Companies' report and data. (ii) The Companies may, within 4 weeks ofreceiving from EPAthe notice described in subparagraph (h)(I), submitto EPA a writtenreport refuting EPA's fmding. EPA will respond to the Companies, in writing, witbin4 weeks ofreceiving the Companies' report.
(i) Company Determination ofInvalidData. (1) Except as described in subparagraph (i)(2), ifthe Companies become aware that circumstances clearly beyond tbe control oftbe Companies orlaboratory will prevent, orhave prevented, development ofscientifically valid data under tbe conditions specified inparagraphs (c) and (e), the Companies remainprohibitedfrom further manufacture and import ofthe PMN substancesbeyond the applicable productionlimit. (2) tbe Companies may submitto EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearly beyondthe control of the Companies orlaboratory will cause or have caused development ofscientifically invalid data. EPA will notifythe Companies ofits response, in writing, within 4 weeks ofreceiving tbe Companies' report. EPA's writtenresponse may eitber:- 14- (i) allow the Companies to continue to manufacture and import the PMN substances beyond the applicable production limit, or (ii) require the Companies to continue to conduct, orto reconduct, the study in compliance withparagraphs (b), (c), and (e)(l) and (2). Ifthere is sufficienttime to conduct or reconduct the study and submit the report and data to EPA before exceeding the production limits, as required by subparagraph ( e)(3), the Companies shall comply with subparagraph ( e)(3). Ifthere is insufficient time for the Companies to comply with subparagraph (e)(3), the Companies may exceed the production limit and shall submit the report and data intriplicate to EPA within a reasonable period oftime, all as specified byEPA in the notice described in subparagraph (i)(2). EPA will respond to the Companies, in writing, within 6 weeks ofreceiving the Companies' report and data, as to whether the Companies may continue to manufacture and import beyond the applicable production limit.
G) Unreasonable Risk. (I) EPA maynotify the Companies inwriting thatEPA finds thatthe data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substances will ormay present anunreasonable risk ofinjury to human health orthe enviroument. EPA's notice may specifythat the Companies undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN substances to mitigate exposures to orto better characterize the risks presentedbythe PMN substances. Within2 weeks from receipt ofsuch a notice, the Companies must cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substances, unless either:- 15

- (A) within 2 weeks from receipt ofthe notice described in subparagraph (j)(l), the Companies comply with suchrequirements as EPA's notice specifies; or (B) within 4 weeks from receipt ofthe notice described in subparagraph (j)(l), the Companies submit to EPA a written report refuting EPA's finding and/or the appropriateness ofany additional requirements imposed byEPA. The Companies may continue to manufacture, import, process, distribute, use and dispose ofthe PMN substances in accordance withthe terms ofthis Orderpending EPA's response to the Companies' written report. EPA will respond to the Companies, in writing, within 4 weeks ofreceiving the Companies' report. Withln 2 weeks of receipt ofEPA's written response, the Companies shall complywith any requirements imposed byEPA's response or cease all manufacture, import, processing, distribution, use and disposal of the PMN substances.
(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions intills Testing section, the Companies must continue to obey all the terms ofthis Consent Order until otherwise notified in writing byEPA. The Companies may, based upon submitted test data or other relevant information, petitionEPA to modifY orrevoke provisions ofthis Consent Order pursuantto Part VI ofthis Consent Order.

MANUFACTURING (a)(l) Prohlbition. The Companies shall not cause, encourage, or suggest the manufacture or import ofthe PMN substances by any otherperson, except as described in paragraph (b).

### - 16- (2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation ofa final significant newuse rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA unless the Companies are notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Companies are so notified, subparagraph (a)(l) shall not expire until EPA notifies the Companies in writing that all Federal Court actions involving the SNUR have beenresolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. WhenEPA promulgates a final SNUR for the PMN substances and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Companies shall notifY eachperson whom it causes, encourages or suggests to manufacture or import the PMN substances ofthe existence ofthe SNUR. Suchnotificationmustbe inwriting and must specifically include all limitations contained inthe SNUR which are defined as significant new uses, and which would invoke significant newuse notification to EPA for the PMN substances. Such notice must alsoreference the publication ofthe SNUR for the PMN substances in either the Federal Register orthe Code ofFederal Regulations. (4) Subparagraph (a)(2) shall not negate the effects ofany fully executed Consent Order for Contract Manufacturer entered into underparagraph (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 ofthis Order to manufacture or import the PMN substances according to the following conditions (after this Order has been signed, the Companies maypetitionEPApursuantto Section VI ofthis Orderto

. include additional ContractManufacturers):- 17- (1) The Contact Manufacturer must be under contractto the Companies to manufacture
or import the PMN substances solelyfor the Companies. The contract must specify the identity ofthe 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 ofthe 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 ofa 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 Manufacturer or Company must receive a fully executed copy ofthe Consent Order for the Contract Manufacturer from EPA before the Contract Manufacturer maybegin manufacture or import.(3) Ifat any time, the Companies learn that the Contract Manufacturer has failed to comply with any ofthe conditions specified inthe Consent Order for Contract Manufacturer, the Companies shall immediately cease to cause the Contract Manufacturer to manufacture orimport the PMN substances, unless the ContractManufacturer is in compliance with a SNURfor the PMN substances, orunless the Companies are able to document each ofthe following: (i) That the Companies have, within 5 working days, notified the Contract Manufacturer in writing that the ContractManufacturer has failed to comply with the conditions specified inthe Consent Order for ContractManufacturer. (ii) That, within 15 working days ofnotifying the Contract Manufacturer ofthe noncompliance, the Companies received from the ContractManufacturer, inwriting, a statement- 18

- ofassurance that the ContractManufacturer is aware ofthe terms ofthe Consent Order for Contract Manufacturer and will comply with those terms. (iii) If, after receiving a statement ofassurance from the Contract Manufacturer under subparagraph (B) ofthis Section, the Companies have notice or knowledge that the Contract Manufacturerhas failed to comply with any ofthe conditions specified in the Consent Order for Contract Manufacturer, the Companies shall immediately cease to cause the Contract Manufacturer to manufacture or import the PMN substances, shall notify EPA ofthe failure to comply, and shall resume causing the Contract Manufacturer to manufacture or import the PMN substances only upon written notification from the Agency.
c) The Companies and their Contract Manufacturer(s) shall not manufacture the PMN substances Pll-0487, Pll-0530, Pll-0533, and Pll-0534beyond an annual manufacture and importation volume of[ ] each.

The Companies shall: (a) use the PMN substances Pll-0483, Pll-0527, Pll-0528, Pll-0529, and Pll-0532 as 

### [ ] described inthe PMNs (to manufacture Pll-0487, Pll-0530, Pll-0533, and Pll-0534) and to manufacture [ ]. (b) use the PMN substances Pll-0487, Pll-0530, Pll-0533, andPll- 0534 only as surfactants for [ ] applications under the scenarios described inthe PMNs; and- 19- (c) not use the PMN substances Pll-0487, Pll-0530, Pll-0533, and Pll- 0534 for
consumer spray applications.

DISTRIBUTION (a) ExportNotice Requirement. No later thanthe date ofdistribution, the Compauies shall notify inwritinganyperson to whom it distributes the PMN substances that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substances is subjectto the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in the form in which it appears inthis Consent Order, the following information: (1) the PMNnumber, and (2) either (A) the specific chemical identity ofthe PMN substances, or (B) ifthe specific chemical identity is confidential, the generic chemical identity.
(b) Distribution Requirements. Except as provided inparagraph (c), the Companies shall distribute the PMN substances outside the Compauies, otherthan for disposal, only to a person who has agreed inwriting priorto the date ofdistribution, to: (1) Notify inwriting any person to whom it distributes the PMN substances that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substances is subject to the export notification requirements ofTSCA section 12(b) and 40 CFRPart 707 Subpart D. Such notice shall contain, in the form inwhich it appears inthis Consent Order, the following information: (1) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN substances, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Comply with the same environmental release restrictions, required ofthe Compauies

### -20- in the Disposal and Release to Water sections ofthis Order. (3) Use the PMN substances Pll-0483, Pll-0527, Pll-0528, Pll-0529, and Pll-0532 only as chemical intermediates described inthe PMNs and to [ ]; 

### (4) Use the PMN substances Pll-0487, Pll-0530,Pll-0533, and Pll- 0534 only as surfactants for [ ] applications under the scenarios described inthe PMNs; and (5) Notuse the PMN substances Pll-048'7, Pll-0530, Pll-0533, and Pll-0534 for
consumer spray applications. (c) Temporary Transport and Storage. Notwithstanding paragraph (b), 

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

### sealed containers provided the following three conditions are met: (1) Subsequent to any such exempt temporary transport or storage ofsealed containers, the PMN substances may be distributed only to the Companies or a person who has given the Companies the written agreement required by paragraph (b). (2) Anyhuman exposure or enviromnental 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 ofthe Companies or a person who has giventhe Companies the written agreement required by paragraph (b). 

### (3) A statement ofthe health hazards(s) and precautionary measure(s), ifany, identified by the Companies for the PMN substance; the identity bywhich the PMN substance may be commonly recognized; a statement ofthe enviromnental hazard(s) and precautionary measure(s),- 21

- ifany, identified bythe Companies for the PMN substance; a statement ofexposure and precautionary measure(s), ifany, identified bythe Companies for the PMN substance; and the
name and address ofthe manufacturer or a responsible party who canprovide additional information on the substance for hazard evaluation and any appropriate emergencyprocedures. The label shall not conflict with the requirements ofthe Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued underthat 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 obtainknowledge that a recipient ofthe substances has failed to comply with any ofthe conditions specified inparagraph (b) ofthis Distribution section or, afterparagraph (b)(2) expires in accordance with subparagraph ( e)(l), has engaged in a significant new use ofthe PMN substances (as defined in 40 CFR Part 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 ofthe following: (l) That the Companies have, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe conditions specified inparagraph (b) of this Distribution section, or has engaged in a significant newuse ofthe PMN substances without submitting a significant newuse notice to EPA. (2) That, within 15 working days ofnotifying the recipient ofthe noncompliance, the Companies received from the recipient, inwriting, a statement ofassurance thatthe recipient is
aware ofthe terms ofparagraph (b) ofthis Distribution section and will comply with those terms,-22-
or is aware ofthe terms ofthe significant newuse rule for the PMN substances and will not engage in a significant newuse without submitting a significant new use notice to EPA. (3) If, after receiving a statement ofassurance from a recipient under subparagraph (d)(2) ofthis Distribution section, the Companies obtain knowledge that the recipient has failed to comply with any ofthe conditions specified inparagraph (b) ofthis Distribution section, or has engaged in a significant new use ofthe PMN substances without submitting a significant
newuse 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 onlyupon written notification from the Agency.
(e) Sunset Following SNUR. (1) Paragraph (b)(2) ofthis Distribution section shall expire 75 days after promulgation ofa fmal SNUR for the PMN substances under section 5(a)(2) ofTSCA, unless the Companies are notified on orbefore that day ofan action in a Federal Court seeking judicial review ofthe SNUR. Ifthe Companies are so notified, paragraph (b)(2) ofthis Distribution section shall not expire until EPA notifies the Companies in writing that all Federal Court actions involving the SNUR have beenresolved and the validity ofthe SNUR affirmed. (2) When EPA promulgates a final SNUR for the PMN substances and paragraph (b)(2) ofthis Distribution section expires in accordance with subparagraph ( e)(I), the Companies shall notify each person to whom it distributes the PMN substances ofthe existence ofthe SNUR. Such notification must be inwriting and must specifically include all limitations contained in the SNUR which are defined as significant newuses, and whichwould invoke significant newuse notification to EPA for the PMN substances. Such notice must also reference the publication of the SNUR for these PMN substances in either the Federal Register or the Code ofFederal

### -23- Regulations. After promulgation ofa SNUR and expiration ofsubparagraph (b)(2), such notice may substitute for the written agreement required inthe introductory clause ofparagraph(b); so that, ifthe Companies provide suchnotice to the persons to whom it distributes the PMN substances, then the Companies are not required to obtainfrom suchpersons the written agreement specified inparagraph (b).

DISPOSAL The Companies shall dispose ofthe PMN substances and any waste containing the PMN substances from manufacturing andprocessing 

### only as follows: incinerate the waste in
an incinerator operating at the temperature ofat least I000 degrees C and a residence time ofminimum of2 seconds. Any tank or vessel washings, residues from transport vessels ortanks, and similar materials that are captured and retained inthe normal
course ofmanufacturing and processing for re-use in manufacturing ofthe PMN substances orproducts made from the PMN substances are exempt from this method of disposal. This provision does not supersede orpreempt any applicable federal, state, and local laws and regulations ifthose laws are more stringent than the requirements below.

RELEASE TO WATER This provision does not supersede orpreempt any applicable federal, state, and local laws and regulations. (Those other laws maybe more stringent thanthe requirements below.)-24- the Companies are prohibited from anypredictable orpurposeful release ofthe PMN substances,
or any manufacturing orprocessing waste streams containing any ofthe PMN substances to the waters ofthe United States, except [

].

RISK NOTIFICATION (a) Ifas a result ofthe test data required under the terms ofthis Order, the Companies become
aware that the PMN substances maypresent a risk ofinjuryto human health orthe environment (or is so notified by EPA), the Companies must incorporate this new information, and any information on methods for protecting against suchrisk, into a Material Safety Data Sheet ("MSDS") for the PMN substances, as described in40 CFR section 721.72(c), within 90 days from the time the Companies become aware ofthe newinformation. Ifthe PMN substances are not being manufactured, imported, processed, orused in the Companies' workplace, the Companies must add the newinformation to anMSDS before the PMN substances are reintroduced into the workplace.
(b) the Companies must ensure thatpersons who will receive the PMN substances from the Companies (including any Contract Manufacturer(s) (as described inparagraph (b) ofthe Manufacturing section ofthis Order), or who have received the PMN substances.from the Companies within 5 years from the date the Companies become aware ofthe new information-25- described inparagraph (a) ofthis section, are provided an MSDS containing the information required underparagraph (a) within 90 days from the time the Companies become aware ofthe
newinformation.



### III. RECORDKEEPING (a) Records. The Compauies shall maintainthe following records until 5 years afterthe date they are created and shall make them available for inspection and copying byEPA in accordance with section 11 ofTSCA: (I) Exemptions. Records documenting that the PMN substances did in fact qualifY for any one or more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfY all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed by the Companies. Any amounts or batches ofthe PMN substances eligible for the export only exemption in Section I, Paragraph (b)(l) ofthis Order are exempt from all the requirements in this Recordkeeping section, ifthe Companies maintain, for 5 years from the date oftheir creation, copies ofthe export label and export notice to EPA, required by TSCA sections 12(a)(l)(B) and !2(b), respectively. Any amounts orbatches ofthe PMN substances eligible for the research and development exemption in Section I, Paragraph (b)(2) of this Order are exempt from all the requirements inthis Recordkeeping section, ifthe Companies maintain, for 5 years from the date oftheir creation, the records required by 40 CFR 720.78(b). For any amounts orbatches ofthe PMN substances claimedto be eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the Compauies shall keep records demonstrating qualification for that exemption as well as the records specified inparagraphs (3)-26- and (4) below, but is exempt from the other recordkeeping requirements inthis Recordkeeping section; (2) Records documenting compliance withthe Chemical Synthesis and Composition; (3) Records documenting the manufacture and importation volume ofthe PMN substances and the corresponding dates ofmanufacture and import; ( 4) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Companies directly sell or transfers the PMN substances, the date ofeach sale or transfer, and the quantity ofthe substances sold or transferred on such date; (5) Records documenting the address ofall sites ofmanufacture, import, processing, and use; (6) Records documenting compliance with any applicable manufacturing, processing, use, disposal and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections ofthis Order, including distributees' written agreement to comply withthe Distribution section ofthis Order; (7) Records documenting compliance with any applicable disposal requirements under the Disposal section ofthis Order, including method ofdisposal, location ofdisposal sites, dates ofdisposal, and volume ofPMN substances disposed. Where the estimated disposal volume is not knownto 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;

### -27- (8) Records documenting establishment and implementaiion ofprocedures that ensure compliance with any applicable water discharge limitation in the Release to Water section ofthis Order; (9) Copies ofany Transfer documents and notices required by the Successor Liability section ofthis Order, ifapplicable; and, (10) The Companies shall keep a copy ofthis Order at each ofits sites where the PMN substances is manufactured, imported, processed, or used.
(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Companies and its Contract Manufacturer, ifapplicable, and notto activities ofthe 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 ofinformation" unless this Order displays a currently valid control number from the Office ofManagement and Budget ("OMB''), and EPA so informsthe Companies. The "collection ofinformation" required inthis 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 Reguest for Information. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyancesassociated with the PMN substances. To facilitate such inspections, EPA personnel may contact the Companies in advance to request information pertinentto the scheduling and conduct ofsuch inspections. Such requests may be written or oral. The types ofinformationthat EPAmay request include, but are not limited to, the following: (l) Expected dates and times whenthe PMN substances will be in production withinthe subsequent 12 months; (2) Current workshift schedules for workers who are involvedin activities associated with the PMN substances and may reasonablybe exposed to the PMN substances; (3) Currentjob 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 withthe PMN substances and may reasonably be exposed to the PMN substances that
are collected during the manufacture or processing ofthe PMN substances; (5) Records required bythe Recordkeeping section ofthis Order; and/or, (6) Any other information reasonably related to determining compliance withthis Order
or conducting aninspectionfor thatpurpose.
(b) Company's Response. The Companies shall respond to suchrequests within a reasonable period oftime, but inno event later than 30 days after receiving EPA's request. Whenrequested inwriting by EPA, the Companies' response shall be inwriting. To the extentthe information is knownto orreasonably ascertainable by the Companies at the time ofthe request, the Companies' response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests.-29-
(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the Companies submit to EPA pursuantto paragraph (b) shall be protected in accordance with §14 of TSCA and 40 CFRPart 2.

V. SUCCESSORLIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by whichthe Companies" rights and obligations under this Order maybe transferred whenthe Companies transfer its interests in the PMN substances, including the right to manufacture the PMN substances, to another person outside the Companies (the "Successor in Interest").
(b) Relation ofTransfer. Date to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Companies to the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN substances from the Companies pursuantto 40 CFR 720.102, the Successor in Interest must submit a newPMNto EPA and comply fully with Section 5(a)(l) ofTSCA and 40 CFR part 720 before commencing manufacture or import ofthe PMN substances. (2) AfterNOC. Ifthe transfer from the Companies to the Successor inInterest is effective after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and shall notbe required to submit a newPMN to EPA.
(c) Definitions. The following definitions apply to this Successor Liability section ofthe Order:-30- (1) "Successor inInterest" means a person outside the Companies Who has acquired the Companies' full interest inthe rights to manufacture the PMN substances, including all ownership rights and legal liabilities, through a transfer document signed bythe Companies, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe 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 inInterestmust 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, includingthe right to manufacture the PMN substances, from the Companies to the Successor in Interest.
(d) Notices. (1) Notice to Successor in Interest. On orbefore the effective date ofthe transfer, the Companies shall provide to the Successorin Interest, byregistered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated byreference as Attachment B to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Companies shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Enviromnental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document mustbe maintained by the Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substances- 31

- is manufactured orimported. Copies ofthe Transfer Document must also be made available for inspectionpursuant to Section II ofTSCA, wust state the effective date oftransfer, and must containprovisions which expresslytransfer liability for the PMN substances under the terms of this Order from the Companies to the Successor in Interest.
(e) Liability. (1) The Companies shall be liable for compliance with the requirements ofthis Order until the effective date ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance withthe requirements ofthis Order effective as ofthe date oftransfer. (3) Nothing inthis section shall be construed to prohibit the Agency from taking enforcement action against the Companies after the effective date ofthe transfer for actions taken, or omissions made, during the time inwhich the Companies manufactured, processed, used, distributed in commerce, or disposed ofthe PMN substances pursuantto the terms ofthis Consent Order.
(f) Obligations to Submit Test Dataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Orderrequires the Companies to submit test data to EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMN substances manufactured and imported bythe Companies up to the date oftransfer shall counttowards the test trigger applicable to the Successor in Interest.

### -32- VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Companies may petition EPA at any time, based upon newinformation on the human health or environmental effects of, orhuman exposure to or environmental release of, the PMN substances, to modify orrevoke substantive provisions ofthis Order. The exposures and risks identified byEPA during its review ofthe PMN substances and the informationEPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessment ofthe test data or other information that supports the findings inthis Order, an examination ofnewtest data or other information or analysis, and any other relevant information. EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will notpresent an unreasonable risk ofinjury to health or the environment and will notresult in significant or substantial human exposure or substantial environmental release inthe absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects ofthe PMN substances. In addition, the Companies may petitionEPA at any time to make other modifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.

### -33- 

### VII. EFFECT OF CONSENT ORDER (a) Waiver. By c;onsen(ingto the entry ofthis Order, the Companies waive their rights to file objections to this Order pursuant to section 5(e)(l)(C) ofTSCA, to receive service ofthis Order
no later than 45 days before the end ofthe reviewpeliodpursuant to section 5(e)(l)(B) ofTSCA, and to challenge the validity ofthis Orderin 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 Companies as to the facts orconclusions underlying the Agency's determinations inthis proceeding. Tills waiver does not affect any otherlights 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 bythe Companies (per section 14 ofTSCA, 40 CFR Part 720 Subpart

### E, and 40 CFR Part 2) iscorrectly 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 withln the brackets.

# l~) vlevtcLlbJ) Date 

# iI 

# I!-Jn 

# I t.o/3 Date Malia J. Doa, h D., Director Chemical Control Division Office ofPollution Prevention and Toxics

Name: [ Title: [ Company: [ 

### . ]Date Name: [ 

### Title: [ Company: [' 

## J J 

## J

### ATTACHMENT A DEFINITIONS Note: The attached Order may not contain some of the terms defined below. "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed bythe Chemical Abstracts Service's rules of nomenclature, or a name which will clearly identify a chemical substance for the purpose of conducting a hazard evaluation. "Company" means the person orpersons subject to this Order. "Commercial use" means the use ofa chemical substances or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to conswners (e.g., a commercial dry cleaning establishment or painting contractor). "Commonna_me" means any designation or identification such as code name, code number, trade name, bra11d name, or generic chemical name used to identify a chemical substance other than by its chemical J';lmn.e. :' Y. "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, orfor any pm·sonf!l use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold or made available to consumers for their use in or around a permanent ortemporary household orresidence, in or around a school, or in recreation. "Container" means any bag, barrel, bottle, box, can, cylinder, drmn, reaction vessel, storage tank, or the like that contains a hazardous chemical. Forpurposes ofthis section, pipes orpiping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "ContractManufacturer" means a person, outside the Companies, who is authorized to manufacture and import the PMN substance under the conditions specified in Part II ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Final Formulation ofthe PMN substance" means the formulated dispersion ofthe PMN '·-") substance inthe form in which it is sojclto customers outside the Companies or transferred to a different business unit within the**Comp<~nies.** The tem1 does not include intermediate dilutions ofthe PMN substance that are intended only for use within the Companies for further dilution prior to sale. • "Identity" 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" ofa person ifit is under the control of, and used only by, the person who transferred it from a labeled container and will only be used bythat person within the work shift in which it is transferred from the labeled container. •,''

.**'·~,** "Initially Isolated Fonnulation¥ofthe PMN substance" means a common intermediate PMN formulation, as it exists when fltst·produced and isolated after the polymer manufacturing process, that can be further processed or repackaged at the direction ofthe Companies to result ultimately in one or more final formulations ofthe PMN substance. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance. "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemical substances and the workplace air may occur. "Non-industrial use" means use other than at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" mea.11s thec!jtlmical substance described in the Premanufacture notice submittedby the Companies relevant

# tothis Order. "Process stream" means all reasonablyanticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofprocessing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA-approved protocol, orthe Good Laboratory Practice Standards at 40 CFRPart 792 without prior or subsequent Agency approval that prevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to pem1it a reasoned evaluation of the potential risk ofinjury to human health or the environment ofthe PMN substance.A-3 "Sealed container" means a closed container that is physically and chemically suitable for long-tem1 containment ofthe PMN substance, and from which there will be neither human exposure to nor environmental release ofthe PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Waters ofthe United States" has the meaning set forth in 40 CFR 122.2. "Workplace" means an establishment at one geographic location containing one ormore work areas.Company (Transferor) , ATTACHMENT B NOTICE OF TRA.NSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

PMNNumber
I. Transfer ofManufacture Rights. Effective on , the Companies did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substances, which was the subject ofa premanufacture notice ("PMN") and is governed by a Consent Order issued bythe U.S. Environmental Protection Agency ("EPA") under the authority of§5(e) ofthe Toxic Substances Control Act ("TSCA," 

### 15 U.S.C. §2604(e)).
2. Assumption ofLiability. The Succe,,ssor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissiorls governed by the applicable Consent Order limiting manufacture, processing, use, distributionin commerce and disposal ofthe PMN substances, shall be the responsibility ofthe Successpdn Ipterest. Successor in Interest also certifies that it is incorporated, licensed, or doing busines1 inthe 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 Sectionl4 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 modifica!j'on shall be explained in detail in an attachment to this Notice ofTransfer. Information whicqhas been previously disclosed to the public (e.g., a chemical identity that was not claimedas CBI by the original submitter) would not subsequently be eligible for confidential treatment under this Notice ofTransfer. ,-·,<,B-2 

### NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER (continued) Company (Transferor) 

### PMNNumber
Signature ofAuthorized Official Date
PrintedName ofAuthorized Official
Title ofAuthorized Official

Successor in Interest


### Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip CodeB-3 

### NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER (continued)

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