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UN ITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFIC E OF POLLUTION PREVENTION AND TOX IC S

REGULATION OF NEW CHEM ICA L SUBSTANCES PEN DING DEVELO PMENT OF INFORMATION

In the matte r of: ) ) ) ) ) ) Premanufacture Notice Number:



### [ ] ' ·**,·~ I**  

## EPA SANITIZED

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

Consent Order, Consen t Order for Contract Manufacturers, and Determinat ions Supporting th e Con s ent Orders'

. II TABLE OF CONT E NTS Preamble I. Introducti o n II. Summary of Tem1s of the Order Ill. Co nt en ts of PMN s IV
. EPA 's Assessmen t of E xposu r e and Ri s k V
. EPA· s Conclusions of Law V I. In fo rmati on Required to Eva l uate Human Hea lth and Env ironmental Effects
Co nse nt Order I. Scope of Applicab ilit y and Exempt io ns II. Te rm s of Manufactu r e (defi ned by s tatute to include im port)
. Proces s in g , Qi s tribution in Commerce, Use, and Disposa l Pending Subm iss ion and Evaluation of In formation III. Recordkeepin g IV. Requests fo r Pre -In spec ti o n In fo rm ation V. Successor Liability Upon Transfer of Consent Order VI. Modifica tion and R evocat ion of Consent Order VII. Effect of Consen t Orde r Attach m ent A

- Definiti ons Attachmen t B- Notice of Transfe r of Conse nt Order Attachment C

- Consent Order for Co ntract Manufac turer Attachment D- K ey Elements of Bi odeg radation Testing of Fluorotelomer based Chemica l sIll


## PREAMBLE I. 

### IN TROD UC TIO N 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 ("t he PMN substances") submitted by [ 

### J ("the Compan ies") , 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 unl awful for any person to fail or refu se to comply with any provision of§ 5 or any order is sued under§ 5. Violators may be subjec t to various penaltie s and to both criminal and civil liability pursuant to § 16, and to specific e nforcement and sei z ure pursuant to§ 17. In add iti on, chemical substances subject to an Order i ssued und er§ 5 of TSCA, such as this one, are subject to the § 12(b) export notice requirement.



### II. SUMMA RY OF TE R MS OF THE ORD ER The Consent Order for the PMN subs tances require s th e Companies to: (I) ·Record and report [ ] impurities of the starting [ ] ra w materials; (2) Not exceed the maximum established leve ls 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 with in [ ] months from th e Consent Order effect ive date
. (b) Tier2 tests: [ ] after EPA specifies the testing for Tier 2. Production of P1 1- 0484 and P-11-0543 can continue
.at annual production volumes [ ). (c) Tier 3 tes ts: ( ] after EPA specifies the testing for Tier 3. Production of P-11**~0484** and P-11-0543 can continue at the ann ual production volumes [ ]. (4 ) Use the chemical substances Pll-0484 and Pll-0543 only as surfac tants for [ ] applications as described in the PMNs; ( 5) Not use the PMN substances in any consumer spra y applications; (6) Distribute the PMN subs tances only to a person that agrees to follow the same restrictions (except for testing r equirements li sted in the Testing sect ion of the Consent Ord er); ( 7) Comply with the Release to water provisions; ( 8) Incinerate all waste containing any of the PMN substances from manufacturing and processing (except for th e 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 temp erature of minimum I 000 degrees C and residencetime of minimum 2 seconds; and (9) Mainta in ce rtain records. v

A Consent Order for Contract Manufacturers i s attached (Attachment C) to extend these require ments 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 . CONT ENTS OF PMN By sig nin g this Order, the Companies repre se nt 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. Confident ial Business Information C laim s (Bracketed in the Preamble and Order): Compan ie s' identities; chemical identities; impuriti es; synonyms; production volumes; specific use; operation descriptions, including exposure and release estimates; and physical/chem ical properties and, time frames. Chem ical Identity: Specific: · P-11-0484: [ ] Generic: alkyl sulfate saltVI

P-1 1-0543: [ Generic: po lyfluori natcd al ky l quaternary amine chloride Use: Specific: [ Generic: surfactants Es timated Maximum I2-Month Production Volume du ring 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 eco toxicity tests for fish , daplmia, and algae an d , additional published literature [ substances. ] on the environmental fat e of the PMN

IV. E PA ' S ASSESSMENT OF EXPOSURE AND RISK Based on the properties of th e PMN substances and test data on analogous perfluorinated chemicals an d potent ial pernuorinated degradation products such as perfluorooctanoic acid (PFOA) , perfluorooctanesu l fonate (PFOS), perfluo rohexane su lfona t e (PFHS), and IH, IH , 2H,2H-perfluorooctanesu lfonic acid (6 -2 FTSA), EPA has identified human health and ecotoxicity concerns . H

uman Health Effects Summarv : Based on the analysis of the available test data for surfactan t properties of analogousVll substances and the degradat ion 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 inhal ed. Toxicity studies on PFOA and PFOS indicate liver toxicit y, blood toxicity, male reproductive toxicity, immunosuppression, and oncogenicity. These factors, taken toge ther, raise concerns for potential adve rs e chronic effects in hum ans and wildli fe.
Ecotoxicity and Environmental Effects Summary: The PMN substances sub j ect to this Order, P-11-0484 and P-11

-0543, and/or degradation products have been identified as hav ing a potentia l
concern for ecotoxicity. Based on submitted test da ta on for P-11-0484 , EPA determined that toxicity to aquatic organisms may occur at concentrations that exceed the calculated concentratio ns of concern (COC) with the clu·onic COCs of2,800 and 1 ppb fo r P-11 · 0484 and P-11-0543, respectively, and ac ute COCs for P-11-0484 of 15 ,2 00 ppb and , for P11-0543, of2 ppb. EPA determined that P-11-0543 was acute ly toxic to daphnids and algae and potentia ll y 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 chron ically toxic. EPA believes that addit ional testing to characterize chronic fish and aquatic in vertebra te ecotoxicity is needed. This testing wi ll contribute to. de fining the potenti al environmental hazard for the two PMN substances.VIII Ecotoxicity Profile of P-11-0484 and P-11-0543 based on Experi mental Aquatic Toxicity Values (Adjusted for the Purity)*.

Test Organ i sm P- 11

- 0484 P-11-0543 (mg/ L ) ( mg/ L) Fish 9 6 hour LCso 318 >30 Da phnid 48 hour EC5 o 76 6.6 Green algae 72 ho ur EC 5 0 264 < 0.009 Fish ChV 

## - - Daph nid ChV 

## - - Green algae ChV < 28 < 0.009

- = data not submitted 

## * Bas ed o n additional information from the submitter , the purity of P-11-0 484 and P-11-0543 u s ed in the toxicity testing was [ ] , respectively.
The abiotic and biotic degradation of P-11-0484 and P

- 1 1- 0543 are not well understood. Only limited information exists on th e identity of possible intermediates and stable end products. The publi s hed literature (including the published literature provided by the Companies) do not prov ide enough information to allow an understanding of the abiotic and biotic degradation pathways , id enti ty of potentially toxicologically significant intermediates and end products, and their rate s of formation and decline. Based on data for analogous perfluorinated chemicals, pernu oro o ct anoic acid (PFOA) , perOuorooctanesu lfonate (PFOS), and perOuorohexane sulf o nate ( PFHS ), EPA ha s de termined that the PMN substance s and their de gradation products wi ll pe rsist in the environment, cou ld bioaccumu late or biomagnify, and could be toxic to people, wild mammals, and birds ( " PBT " ). The presumed perfluorinated degradants for the PMN substanc es include perfluorohexanoic acid (PFHxA). Biodegradation and photolysis tests of analo gous substances to PFOA and PFOS indicate little or no biodegradation or photolysis ofIX 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 wil dlife 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 Environmenta l Release Summaries: Manufacturing will take place at the following [ ] sites: 

### [

Waste (that contain the PMN substances) to the env ironment f rom manufacturing [ ] and processing wi ll be incinerated. Processing [ 

### J will take place at [

and inhalation exposures are [
].

Env iron mental 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 CONCLUSI O NS OF LAW The following findings constitute the basis of the Consen t Order : (a) EPA is unabl e to determine th e potential for human health and envi ro nm ental effects from exposure to the PMN substances and their potentia l degrada ti on products. EPA therefore concludes, pursuant to § S(e)(I)(A)(i) ofTSCA, that the inf otm at ion ava ilable to the Agency is in s uffic ient to permit a r easo ned evaluation of the human health and env iron m ental effects of th e PMN substances and potentia l degrada ti on products.
(b) In light ofthe potential risk of human health and env ironmental effec ts posed by th e uncont rolled manufacture (de fined by statute to include imp ort ), processing, distribution in
commer ce, use, and disposal of the PMN substances, EPA has co ncluded, pursuant to § 5(e)(I)(A)(ii)(I) ofTSCA, that uncontrolled manufacture , processing, distribution in commerce,
use, and disposal of the PMN sub stances may present an unreasonable risk of injury to human health and the environment.
(c) In light of the estimated produc ti on volumes of, and human exposure to, the PMN subs tances and potential degradat ion pro du cts, EPA has furth er co nclud ed , pursuan t to § 5(e)( 1 )(A)( ii )( JI ) of TSC/\. th at the PMN s ubstances will be produced in substan ti al quantities and may reasonably be anticipated to enter the enviro nment in substan tial quan titi es. and th e r e may be s ign ifi can t (o r substantial) human exposu r e to th e s ubs tances and potential degradation products.XI V I. INF ORMA TIO N RE QU IRE D TO EVALUA T E HUMAN H EAL TH AN D ENVIRONMEN T A L EFFEC T S

. Triggered Testing. The Order prohibits the Companies from exceeding th e specified production volumes unless the Companies submit the inform ation described in the Testing
sec ti on of this Order for P-11-0484 and P-11-0543 in accorda nce with the conditions specified in the Testing section. In ad dition , the Companies shall not manufac ture or cause , encourage or suggest that a [ ] manufacturer manufacture the PMN substances unless a routine testing of the [ starti ng raw material for [ ] impuritie s by the Companies or as evidenced by a Ce11ificatc of Analysis fr om 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 materia l 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 -0 484 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 eva lu ated by EPA, and the use in consumer spray application is approved by EPA: acute inhalation test , OPPTS 870.1300 , and a 90-day inh alat ion study, OPPTS 870.3465, with a post-exposure observation perio d of up to 3 month s and bronchoalveolar lavage nuid (BALF) analysis. EPA has determined that the test results could allow the Age nc y to consider consumer spray applica ti on 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 e ffect until the Order is
.modified or revoked by EPA based on submission of that
or oth er 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 consequen t analytical difficulties, some modification of the protocols may be necessary. These and other modifications will be agreed upon between EPA and the Companies.

## CONSE N T ORDER I. 

### SC OPE OF AP P LI CABILITY AN D E XEMPTIO NS (a) Scope. The requirements of thi s Order apply to all commercial manufactur ing,**proc~ssing,** distribution in commerce, use and disposa l of the following chemical substances: P-1 1-0484 , [ [ subm itt ed by [ ], and P-11- 0543, ] ("t he PMN substances"), 

### J (" ' the Co mp anie s"), to take effect upon expiration of th e PMN review period, ex cept to the extent that th ose act ivit ies
ar

e exempted by paragraph (b).
(b) Exe mpti ons. Manufacturing, processing, di stribution in commerce, use and disposal of the PMN substa nces are e xempt from the requirements of this Order (except th e r equirement s in th e R

eco _rdkeep ing and Successor Liability Upon Transfer Of Consent Order sections) only to the extent that (1) th ese activities are conducted in full compl iance with all applicable requiremen ts of the fo ll ow ing exempt ions, and (2) such compliance is docum e nted by appropriate
r ecordkeepi ng as required in the R eco rd keepin g sec ti o n o f this Order. ( 1) Export. Until the Companies begin commercial manuf ac ture of th e PMN subs tanc es for use in the U nited States, the requirements of this Order do not apply to manufacture, processing o r dis tribution in commerce of the PMN substances so lely for export in accordance- 2 - with TSCA § 12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However , once the C o mpanies begin to manufacture the PMN su bstances for use in the United States, no further activity by the Compan ies involving the PMN substances i s exempt as "solely for export" even if
some amoun t of the PMN substances is later exp011ed. At this point, the requirements of this Order apply to all activ ities associated with the PMN subst ance s while in the tenitory of the Un ited 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 vo lume test triggers in the Testing section of this Order. (2) Research & Development ("R&D"). The requirement s of this Order do not apply to manufacturing , processing, distribution in commerce, usc and disposal of the PMN substances in smal l quantities solely for research and development in accordance wi th 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 P MN substances when they are produc ed, without separate commercial intent , on ly as a "byproduct" as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). (4) o Separate Comme rcial 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 C FR 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 Exe mption ( " 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 effect iv e date of thi s Consent Ord er.



### II. TERMS OF MANUFACTURE, PROCESSING, DISTRJBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUAT IO N OF INFORMATIO N

PROHIBITION The Compan ies are prohibited from manufacturing (defined by statute to include import) the PMN substances in the Unite d States, for any non-exempt commercial purpose, pending the development of inform ation necessa ry fo r a reasoned eva lu ati o n of the human hea lth and environmental effects of the substances , and the completion of EPA's r eview of, and regulatory action based on, th at information, except in accordance wit h the condi ti ons described in th is Order.- 4 - 

### CH EM ICA L SYNTH ES I S AN D C OMPO SI TION
(a) R estric tion s . The Companies shall not manufacture or cause, encourage or suggest that a [

] manufacturer manufacture the PMN sub stances unless test ing of the [ star tin g ra·w material by the Companies or as evidenced by a Certificate of Ana lysis from the raw material s uppli e r, 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 subs tances are to be made, the Compani es s hall test the In itia ll y Iso lated Fo rmu l at ions of the PMN subs tances for the ana lytcs spec ified in Tab le 3 of th is Order to con[jrm th at c ross-con taminat ion from the manufacture of th e product with [ ] has no t occurred. Testing shall be conducted upon initial commencement of manufacture and at leas t annually there after, until one year after the date of the last manufacture or processing of a product that contains [ ] products at that facility
. No testing of In itiall y Isolated Fo rmul atio ns of the PMN subs tances will be required if[ ] ha ve not been previously manufactured or processed or were not manufactured or processed at the facility within one year of manufacturing or proce ss ing of the PMN subs tances. The Companies s hall submit all analytical test protocols to EPA for approva l prior to initiating testing
. Protoc o ls should be s ubmitted to the OPPT Documen t Contro l Office (7407M), 1200 Penn sylva nia Ave, N.W., Wa s hington , DC 20460; Att en tio n : Program Manager. New Chem ica ls Program, Chemical Con trol Division
. EPA will r espond to th e Companies
within [ ] weeks of r e cei ving the vvritten protocols
. The Compa nies sha ll r ecord the levels of impurities [ ] associated with the PMN substances manufac tured by the Companies and/or the Con tract Manufacturer , as- 5

- specified below. The Companies s hall record analytes pre se nt in the [ ], at each manufacturing fac ilit y using thi s raw material (as**sho~n** in Table I). Further, the Companies will also annually record the analyte [ ] pre s ent in th e ) starti ng raw material (as s hown in Table 2). The Companies shall make its best effort to minimize the se impurities. If any new man u fact urin g fac iliti es are added , or the manufacturing process is sign ifi cantly alt ered, then the PMN subs tanc es must be tested at commencement of these actions and annually thereafter.
(b) Reporting
. The Compa ni es shall tes t representative sampl es of the Initiall y Iso lat ed Formul at ion s of the PMN substanc es manufactured by th e Companies and/ or the Contract Manufacturer to de termine comp li ance with the require ments in paragraph (a). The Companies
s hall
.tes t the Initi all y Iso lated Fo rmulati o ns of the PMN substances at each man uf ac turin g facility both (I) at the initial comme ncement of non-exempt manuf ac ture of the PMN s ub stances
at that fac ility , and (2) at le as t annually thereafte r during every year in wh ich the PMN
' substances ar e manufactured at that facil it y. If any ne w manu fac turin g fac ility is added, or if the process of manufacture of the PMN substances or any intermediate thereof is sig nific an tl y altered, then the In itially Isolated Formulation of th e PMN s ub sta nces must be te sted at
co mm e nceme nt of th ese acti o ns and annually thereafter , as se t fo r th above. If the PMN substances ar e imported , the Companies shall obtain from the foreign manufacturer written documentation to certify that represe nt ati ve samp les of the im ported for m of the PM N**subst~nces** ha ve been tested, co nsistent wi th th e requirements of thi s paragraph (b) and determined to comply with the req uiremen ts of paragrap h (a). The Companies s hall rep.o 11 th e 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 interm ed iate thereof is significan tly al tered. The Companies shall continue to report th ese 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 it se l f, the Companies shall , for the [ ] starting raw material , annually report (I) the average values and the range of values, inc luding outlying data , for the routine testing for the analytes spec ifi ed in Table I , and (2) the results of the annual testing for the analyte specified in Table 2. TABLE I: Chemicals to be Routine ly Tested in [ ] Starting Raw Material Ana lyte CAS Number Limit in [ ] [ ] 

### [ ] [ ] minimum [ ] [ 

### J [ 

### 1 [ ] [ ]
TABLE 2: Chemica ls to be Tested at least Annually in [ ] Starting Raw Material Analyte 

# I CAS Nu mber 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 [ ] [ ] [ ] [ ] [ ] 

### [ ] [ ] [ 

### )

TEST IN G (a) Section 8(e) Reporting. Reports of information on the PMN substances wh ich reasonabl y supports the conclusion that the PMN substances pr esents a substantial ri sk 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 th e substances are subject to this Consent Order. Addi tional information r ega rding sec tion 8(e) reporting requirements can be fou nd at www.epa.gov /

oppt l tsca8e. (b) Notice of Study Scheduling. The Company shall notif y, in writing , the EPA Monitorin g Assistance and Media Pro grams Division (2227 A), Office of Enforcement and Compliance Assu rance, U.S. Env ironmental Protection Agency, 1200 Pennsylvania Avenue, .W., Washington , D.C. 20460, of the following information within I0 days of scheduling any study required to be performed pursuant to this Order, or wi thin 15 days after the effective date of this Order, whichever is later: ( I) The date when the study is scheduled to co mm e nc e;

### - 8 - (2) The name and address of the laboratory whic h will conduct th e 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 thi s Consent Order. The vvritten notice should be submitted to EPA as follows: Postal Mail Address U.S. Env ironm ental Protection Agency GLP Section Chief

- Pesticides , Water and Toxics Branch Mon itorin g Assistance and Media Programs Division (2227 A) Office of Enforcement and Compliance Assurance 1200 Pennsylvania !\venue,
.W. Wash in gton, DC 20460

Courier Delivery Address U.S. Env ironmen tal Protection Agency GLP Section Chief

- Pesticides , Water and Toxics Branch Monitoring Assistance and Media Program s Division (2227 A) Office ofEnforceme nt and Compliance Assurance Room 7117B 1200 Pennsylvania Aven ue , N.W
. Washington, DC 20004- 9- (c) Good Laboratory Practice Standards and Test Protocols. Each study performed to address the risks identifi ed in this Order must be conducted according to TSCA Good Laboratory Pract ice Standards at 40 CFR Part 792 and using methodolo gies 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 guidel ines )
. Protocols must be submitted as a support document for the PMN s 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 substa nces beyond the following tim e allowances or aggregate manufacture volumes ("the production limits"), unless the Companies ei th er: (I) conducts the following studies on the PMN substances and submits all final reports and underlying data in acco rd ance with the conditions specified in this Testing section, or (2) submit other relevant information (inc luding test data conducted using altern ate guidelines) to meet these requirements and EPA determines that this other information satisfies th e testing requirements.

. The Companies shall submit quarterly progress rep orts and provide documentation on the progress of the studies via EPA Central Data Exc han ge (COX). The Companies and EPA agree- I 0 - to consult by conference call to discuss the quarterly reports , upon EPA's r eq ue st. Should there be unforeseen events outs id e the control of the Companies or the contract laboratories th at cause the stud ies to be delayed , the Compani es will promptly notify EPA and, if EP A agrees that th e events were un fo re s een and outside the control of the Co mp ani es or th e contract laboratories, EPA will consider extendi ng the test tri g gers.

The following triggered testing on PMN substances, P-11-0 4 84 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 f rom the Consent Order cffect ive date
. (b ) Tier 2 te s ts : [ ] after EPA spec ifi es the testing fo r Tier 2
. Production of P-11-048 4 and P-11-054 3 can cont inu e at annu al production volumes [
]. (c) T ier 3 tests: [ ] after EP A specifies the testing for Tier 3. Production of P-11-0484 and P-11 -0543 can continue at annual production volumes [


### ]

. T ier 1 te s ts (conducted on P-11-484 and P-11-54 3) (NOTE: Protocol s for all Tier I tests have been subm itt ed to and reviewed by EPA)
. Biodegradat ion te s t (Mod i fied Semi Cont inuous Activated Sludge, SCAS , OPPTS Guidel ine 835.5045 or O ECD 302A, or mod ified Zahn- Wellens metho d, OECD 3028, with ana lys is for degradation products- see EPA- 1 1 - ge neral guidance presented in Attachment 2, K ey Elements of Biodegradation Te sti ng of Fluorotelomer Based Chemicals. The Company must look for the C6 and C7 possible degradants specified in Table 4 be low). Mass b alance sho ul d
.be attempted, to the best of the laboratory's abi lity, to ach ieve 70

- 130% over the course of the st ud y.
TABLE 4: PMN S ub s tance s and Potenti al Metabo li tes / Degraclant s for whic h Analysis during Tier 1 and Tier 2 Fate Testing i s Required 

### An al yte [ 

### [ [ [ [ [ ] [ 

### [ ]

Abiot ic Fate tests: Hydrolysis as a f un ctio n of pH and t empera ture UV visible light abso rp tion Direct Photolysis, if wavelengths greater th an 290 nm are abso rb ed in the previous test Indire ct Photolysis Sc r eening Tes t ] ] ] 

### CA S Number [ ]

[ ]



### [ ] 

### J [ ] ] 

### r ] [ ] ] [ ] [ ]

(OPPTS 835.2130, O EC D Ill) (OPPTS 830.7050) (O PPTS 835.22 1 0) (O PPTS 835.5270)- 12

- Tie r 2 Fate tests(conducted on P-11-484 and P-11-543): Anaerobic biodegradabi I ity 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 Ecotoxic ity tests (conducted on the degradants of interes t identified by EPA after EPA review of the Tier I biodegradation test): Fish 96-hr LC50 Flow-through method, analy tical measurement of test substances, mean, measured test concentrations. Acute Daphnia Flow-through method, analytica l 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 I0

OPPTS 850.5400

After the Tier I testing is completed, it will be reviewed and ana lyzed by EPA. Depending on the results of the review , additional testing will be required as described in Tier 3 below. T ie r 3 (conducted on either : (a) P-11-0543 and P- 1 1-0484 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 ducksfor PMN compound and any PBT m etabo li tes ident ified by the fate testing. Human Health hazard tests: Pharmacokinetics study in rats and mice Combined r epeated dose tox icit y s tud y with developmental/ reproduction screening oral1:o ute , species to be determined by the - 13

-

test (870.3650), oral route, species to be dete rmin ed by the r esu l ts of the pharmacokinetics studie s with the following modification s - increa se parental samp le 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 ani mal s continues through lacta ti o n followed by direct dosing of pups until they reach sexual maturation; pup body we ight recorded on lactation days 0, 4, 7, 14, and 21 and then at weekly intervals; tim e of sex ual maturation (i.e
. vag in al openin g and preputial separat ion recorded); litter size can be standardized to 4 pup s/ litter on lactation day 4 (op tional ); at weaning one pup/sex/ li tter can be randomly selected to foflow until sexual maturation

EPA Data R eview (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. I n addition, EPA will consider the persistence, potential bioaccumulation an d toxicity of the PMN substance and its degrad an ts , as well as the potent ial for exposure and re lease to th e environment. EPA is concerned with both potenti al toxicity to humans and terrestr ial and aquat ic spec ies.- I 4- (e) Test Reports. The Companies sha ll : ( 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 s tud y; and (3) submit the fina l report of each study (with an additiona l sanit ized copy, if confiden ti al business information is involved) and all underlying data ("the report and data ' ') to EPA prior to exceeding the app li cable 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 w ith 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 me et 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 s tud y specified in paragraph (d) of this Testing section if notified in writin g 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 sc ientific ally equivoc al , the Compan ies may continue to manufacture (defi ned by s tatute to includ e import) the PMN subs tances beyond the applic able production limit. To seek reli ef from any othe r restrictions of this Order, the Companies may make a second attempt to obtain un equivocal data by reconductin g the study under the conditions specified in paragraph s (b) , (c), and (e) (excep t that the s tud y may be s ubmitted aft er r each in g the app li cab le produc ti on limit). The testing requi r ements may be modified, as necessary to perm it a r easoned eva luati on of th e risks presented by the PMN substances, on ly by mutual co n se nt of EPA and th e Companies.
( h) EPA De t erminati on ofinvalid Data. (I) Except as described in subpa ragrap h (h)(2), if, w ithin 6 weeks of E PA 's r ece ipt of a test report and data, the Companies r e ceive written noti ce that EPA find s that the data ge ne rated by a s tud y are scie ntifi call y inv alid , the Co mp ani es are prohibited from further manufacture (defined by th e statu te to include import) of the PMN substances beyond the applicable product ion limit. (2) The Co mp an ies ma y cont inu e to manufacture (defined by th e s tatute t o in c l ude import) the PMN s ub s tance s beyo nd th e applicabl e production limit on ly if so notified , in writing, by EPA in re spo n se to the Compa nie s' compliance with e ither of the following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) If there is sufficient time to re co ndu ct th e st ud y in comp li ance with pa ragraphs (b), (c), and (e) before exceed in g th e product io n limit specified in paragraph (d), th e Companies may reconduct the stud y . If there i s insuffici ent time to r econduc t the study in compliance wi th paragraphs (b), (c), and (e) before exceeding th e product ion limit specified in paragraph (d), the- 16- Companies may exceed the production limit , but must otherwi se comply with paragraph s (b), (c),
and (e), and shall sub mit th e report and data to EPA with in a reasonable period of time, all as spec ified by EPA in the notice desc ri bed in subparagraph (h)( I )
. EPA w ill r espond to th e Compan ie s . in writ in g, within 6 weeks of rec eiv in g the Co mp ani es' rep ort and data. ( ii ) The Co mpanie s may, w ithin 4 weeks of r eceiving fro m EPA the notice described in subparagraph (h)( I) , s ubmit to EPA a \vritten r eport refuting EPA ' s findin g. EPA will respond to the Companies , in writ in g, wi thin 4 \Vccks of r ece ivin g the Co mpanie s' report.
( i) Co mpany Determination of Invalid Data. ( I ) Except as de scribed in s ubparagraph ( i)(2), if the Companie s become aware that circumstances c learly beyond the cont rol of the C ompanie s or laboratory will pr event, or have prevented, development of sc ie ntificall y valid data under the conditions s pecified in paragraphs (c) and (e), th e Companies r emai n prohibited from further manuf acture ( defined by th e s tatute to include import) of the PMN substances beyond the appl ic ab le production limit. (2) The C ompanies may subm it to EPA , within 2 weeks of first becoming aware of such
c ircum s tance s, a written state ment explain in g why circumstances clearly beyond the co ntrol of the Com panies or laboratory will cause or have caused development of sc ie ntifically inv al id data. EPA wi ll notify th e Companies of its response , in wri ting, w it hin 4 weeks of r ece iv in g the Compani es' r eport. EPA's written r esponse ma y either: (i) allow the Companies to continue to manufacture (defined by th e statute to include import ) the PMN substa nces beyond th e app li cable production limit , or (i i) r eq uire th e Co mpanie s to continue to conduct, or to reconduct , the study in
co mpliance with paragraphs (b), (c), and (e), if there is s ufficient time to conduct or r econd uc t- 17 - the study and subm it the r eport and data to EPA before exceeding the production limit specified in paragraph (d)
. If there is insufficient ti me for the Companies to comply with p aragrap hs (b), (c), and (e) before exceeding the production limit spec i fied in paragraph (d), the Compan ies may exceed the production limit, bu t must otherwise comp ly with paragraphs (b), (c), and (e) , and shall submit the report and data to EPA within a reasonable pe ri od of time , all as specified by EPA
.in the notice described in subparagraph (i)(2). EPA wil l 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 inc lude import) beyond the applicable production limit.
U) Unreasonab le Risk. EPA may notify the Companies in writing that EPA finds that the data generated by a
s tudy are scient ifica ll y valid and unequivocal and indicate that, despite the terms of this Order, th e 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. Withi n 2 weeks f rom rec eipt of such a notice, the Companies mu s t cease all manufactu r e (defined by statute to include import), processing, distribut ion, use and disposal of the PMN substances, unless e ither : (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 s tatute to include import), process, distribute, use and dispose of the PMN substances in accordance with the terms of this Order pending EPA's resp o nse to the Companies' written report. EPA will respond to the Companies, in wri tin g, within 4 weeks of r eceiving th e Companies' repol1. Within 2 weeks of receipt of EPA's written response , the Companies shall comply with any
r equi r ements impos ed by EPA's response or cease all manufacture (defi ned by statute to include import) , processing , dis tr ibution, use and disposal of the PMN substances.
(k) Other Requirements. Regardless of the sa ti sfaction of any other conditions in this Testing sectio n, the Companies must continue to obey all the terms of this Consent Order until otherwise notified in wri tin g by EPA. The Companies may, based upon s ubmitted test data or other rel eva nt inform ation , petition EPA to modify or revoke provisions of this Consen t Order pursuant to Part VI. of this Consent Order.



### MANUFAC TU RI NG (a)( I) Prohibition. The Companies shall not cause, encourage , or suggest the manufacture (defi ned by statute to include import) of the PMN substances by any other person, except as described in paragraph (b). (2) Sunset Fo llo wing SNUR. Subparagraph (a)(!) shall expire 75 days after promulgation of a fin al significant new use rule (" SNUR ") governing the PMN subs tances 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 val idit y of the SNUR affirmed
. (3) Notice of SNUR. When EPA promulgates a fin al SNUR for the PMN substances
and s ubp aragrap h (a)(l) expires in accordance with subparagraph (a)(2), the Companies shall notify each person whom it causes, encou rag es or suggests to manufacture (defined by statu te to include import) the PMN substances of the existence of the SNUR
. Such notification**mu~t** be in writing and must s pecifically include all limitations contained in the SNUR which are defined as sig nificant 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 Co ntract Manufacturer(s) identified in the PMN and li sted in the Preamble of this Order to manufacture (defined by statute to include import) the PMN substances according to the following conditions (after this Ord er 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 quanti ties to be manu fa ctured , and the basic technology to be used for manufacturing. (2) Th e Companies shall obtain from eac h Contract Manufactu r er a signed copy of th e Consen t Order for Contract Manufacturer (attached to thi s 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 Manufac turer. The Consent Order should be submitted to the OPPT Document Control Office (7407M), 1200 Pennsy lvania Ave. N.W., Washington, DC 20460; Attention : Program Manager , New Chemicals Program, Chemical Control Division. The Contract rvlanufacturer or Company must r eceive a fully executed copy of the Co nsent Order for th e Contract Manufacturer f rom 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 immed iately cease to cause the Contract Manufacturer to manuf ac ture the PMN substances, unless the Contract Manufacturer is in compliance wi th a SNUR for the PMN substances, or unless th e Companies are able to documen t each of the**f~ ll** **owing:** (i) That the Companies have, within 5 work in g days, notified the Contract Manufacturer in wt'iting that the Contract Manufacture r has failed to comply with th e 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 Contrac t Manufacturer and will comply with those terms.- 2 1 - (i ii ) If, after receiving a statement of assurance from the Contract Manufacturer under subparagraph (B) of this Section , the Companies have notice or knowledge tha t the Contract Manufacturer ha s 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, sha ll noti fy EPA of the**failur~** to comp ly , and shall resume causing the Contract Manufacturer to manufacture the PMN substances only upon writt\!n notification from the Agency.
c) The Compan ies and their Contract Manufacturer(s) shall not manufacture the PMN substances P-11-0484 and P-11-0543 beyond the annual manufacture (inc lu d ing imp ortat ion) volumes specified in paragraph (d) under "Testing."



### USE The Companies shall: (a) Use the chemica l substances P-11**~0484** and**P~** 1 1-0543 only as surfactants for [ ]; and (b) Not use the PMN substances P -1 I -0484 and P-11- 0543 for consumer spray applications.



### DISTRIBUTIO N (a) Expo rt Notice Requirement. No later than the date of distribution , the Companies shal l- 22- notify in writing any person to whom it distributes the PMN substances th at, 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 appea rs in this Consent Order , the following information: (I) the PMN number. and (2) either (A) the specific chemical identity of the PMN substanc es, or (B) if the specific chemica l identity i s 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 ag reed 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 notificat ion requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice s hall contain, in the form in which it appears in this Consent Order , the following informati on: ( I) the PMN number, and (2) either (A) the specific c hemical identity of the PMN substances, or (B) if the specific chemical identit y is confidential, the generic chemica l identity. (2) Comply with the same environmental relea se restrictions, required of the Companies in the Disposal and Release to Water sect ions of thi s 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 u se the PMN substances P-I 1- 0484 and P-11- 0543 for consumer spray applications
.
(c) Tempora ry Transpo rt 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) Subs equent to any such exempt temporary transport or storage of sealed containers, the PJ'vfN substances may be distributed on ly to the Companies or a person who has given th e 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 give n the Companies the written agreement required by paragraph (b).

· (3) A statement ofthe health hazards (s) and precautionary measure(s) , i f any, identifi ed 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 precauti o nary measure (s), if any, identified by the Companies for th e PJ'vfN substance; a statement of exposure and precautionary me as ure(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 add itional information on the substance for hazard evaluat ion 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 Departm ent of Tran s portation.
(d) Recipient Non-Compliance. If, at any time after commencing distribution in commer ce of the PMN substances, the Companies obtain knowled ge that a recipient of the subs tances has failed to comply with any of the condit ions specified in paragraph (b) of this Di s tribution sec ti o n-24- or, after paragraph (b)(2) expires in accordance with subparagraph (e)( I ), has engaged in a significant new u sc of the PMN su bstances (as defined in 40 CF R Pa11 72 1 , Subpart E) without submi ttin g a significant new use notice to EPA, the Companie s shall cease supp ly in g the substances to that recipient , un less the Compan ies are able to document each of the following: (I) Tha t th e Companies have, within 5 working days, notified the recipient in writing that the recipient has failed to compl y with any of the condi tions specified in paragraph (b) of this Distribut io n sect ion , or has engaged in a s ig nificant new use of the PMN substances without submitt in g a sign i fica nt new usc notice to EPA. (2) That , within 15 working days of notify ing the r ecipient of the noncompliance , the Compan ies r eceived f rom th e recipient, in writing , a statement of assurance that the recipient is
aware of the terms of paragraph (b) of thi s Di stribution section and wi ll comply wi th those terms , or is aware of th e terms of the significant new use rule for the PMN s ubstances and wi ll not enga ge in a s ignificant new use w ithout sub mittin g a significan t new u se notice to EPA. (3) If, af ter recei ving a s tatement of assurance from a r ec ipient under subparagraph (d)(2) of thi s Distribution sec tion , the Compan ies obtain knowledge that the recipient has failed to comp ly with any of the cond iti o ns specified in paragraph (b) of thi s Distribu tion sec tion
. or has engaged in a significant new use of th e PMN s ubs tances withou t s ubmittin g a sign i ficant
new use notic e to EPA, the Companies shal l cease s up ply in g th e PMN s ubstances to that recipient , s hall notify EPA ofthe failure to comply , and shall resume s upplying the PMN subs tan ces to th at recipient only upon wri tten notification f rom the Agency.
(e) Sunse t Fo llowing SNUR. ( I ) Paragrap h (b)(2) of th is Di st ributi on sec ti on sha ll expi r e 75 days af1er promu lgat io n of a final SNUR for the PMN s ubstanc es und er section 5(a)(2) of TSCA.- 2 5- unless the Companies are notifi ed on or before that day of an action in a Fede ral Com1 seekin g judicial revi e w of the SNUR. If the Companie s are so notified , parag rap h (b)(2) of this Distribution sec tion s hall not expire until EPA notifies the Companies in writin g that all Federal Court actions involving the SNUR have been r eso lved and the validity of the SNUR affirmed. (2) When EPA promulgates a fina l SNUR for the PMN substances and paragraph (b)(2) of this Distribution section expires in accordance with subparag raph (e) (! ), the Companies s hall notify each person to whom it distributes the PMN substance s of th e ex i stence of the SNUR. Such notification must be in wr itin g and must specifica ll y include all limit atio ns contained in the SNU R which are defined as significant ne w us es , and which would in vo ke s ignificant new u se notification to EPA for the PMN substance s . Such notice must also re fe rence the publication of the SNUR for these PMN substances in eith er the Federal Regi s ter or the Code of Federal Regulati ons. After promulga ti on 

### cif a SNUR and ex pirat ion of s ubp arag raph (b )(2), such notice may substitute fo r the written agreement required in th e introduc tory clause of parag raph (b); so that, ifthe Companies provide such not ice to th e persons to whom it distributes th e P MN substances, then the Companies ar e not required to obt ai n f rom suc h persons the writte n ag re e ment specified in pa rag raph (b).



### DISPOSAL The Co mpanies sha ll dispos e of th e PMN substances and any was te containing the PMN substances from manufacturing and processing only as follows : incinerate the waste in an inc inerato r operating at the temperature of at le as t I000 degrees C and a re s iden ce time of minimum of2 seco nd s. Any tank or vessel washi ng s, re sidues from transport ves se ls or tanks ,- 26- and s imilar material s th at arc captured and r etained in the normal course of manufacturing and processi ng fo r r e-use in manu factu rin g of the PMN subs tance s or products mad e from th e PMN substances are exempt f rom this method of disposa l.

Thi s provision do es not supe rsede or preempt any applicabl e federal, state, and loca l laws and regulations ifthose laws arc more stringent than the r equi rements be low.

RELEASE TO WATER This provision does not supersede or preempt any app lic ab le fede ral , s tate, and local laws and regulations
. (Those other laws may be mo r e s trin ge nt th an the require ment s below
. ) The Companies are prohibited from any predictab le or purposefu l r elease of the PMN substances , or any manu fac turin g or proces s in g waste streams cont aining any of th e PMN substances to th e waters of the United**~ta es,**  except [

]

.

RISK NO TIFI CAT IO N (a) If as a r esu lt o f the test data required under the terms ofthis Order, th e Co mp an ie s becom e
aware that th e PMN substances may prese nt a risk of injury to hum an health or th e enviro nme nt (or i s so notified by EPA) , the Companies must in co rporate this new inform ati on, and any- 27- information on methods for protecting against such risk, into a Material Safety Data Sheet ("MSDS") for the PMN s ub stances, as described in 40 CFR section 721.72(c), within 90 days from the time the Companies become awar e of the new inform atio n . If the PMN substances are not being manufactured,**proc~ssed,** or used in the Compan ies ' workplace, the Companies must add the new information to an MSDS before the PMN substances are reintroduced into the workp lace .
(c) the Companies must ensure that persons who will receive the PMN substances from the Companies (including any Contrac t Manufacturer(s) (as described in paragraph (b) of the Manufacturing section ofthis Order), or who have received the PMN substances f rom the Compan ies within 5 years from the date th e Compan ies 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
. RECORDKEEPI NG (a) Records. The Companies shall maintain th e 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 sect ion II ofTSCA: (I) Exemptions. Records documenting that the PMN substances did in fact qualify for any one or more of th e 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 c laimed 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 yea rs from the date of their creation, copies of the export label and export notice to EPA, required by TSCA sectio n s 12(a)(l )(B) and 12(b), respectively. Any amou nts 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 documentin g the names and addresses (i ncluding shipment de st ination address, if different) of al l persons outside the site of manufacture to whom the Companies directly sell or transfers th e PMN substances, the date of each sale or transfer, and the quantity of the substances sold or transfe rred 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, includin g distributees' written agreement to comply with the Distr ibution section of this Order; (7) Records documen ting 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 r easonably ascertainable by the Companies, the Companies must maintain other records which demonstrate establ i shment 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 appl icable water discharge limitation in the Release to Water section of this Order; (9) Copies of any Transfer documents and notices r eq uired by the Successor Liability sectio n 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 icabi lity. The provisions of this Recordkeeping Section are applicable only to activities of the Companies and its Contract Manuf acturer, if applicable, and not to activities of the Compan ies' customers.
(c) OMB Contro l Number. Unde r the Pape rw ork Reduction Act and its regulations at 5 CFR Part 132 0, particularly 5 CFR 1320.5(b), the Companies are not required to respond to this "co ll ect ion 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) Consen t Ord er has been approved under currently val id OMB Contro l Number 2070-0012.

IV . REQU ESTS FO R PRE - I NS PE CT IO N INF ORMATION (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 fac iliti es and conveyances associated with the PMN substances. To facilitate such inspec tions, EPA personnel may contact the Companies in advance to request information pertinent to the sche9uling and conduct of such in spec tions. Such requests may be wri tten or oral. The types of information that EPA may request include , bu t are not limited to, the following: (I) Expected dates and times vvhen the PivfN substances will be in production wi thin the subsequent 12 months; (2) Current workshift schedules for workers who are in volved in act ivi ties associated with the PMN substances and may r easonably be exposed to the PMN substances; (3) Current job titles or categories for workers who are involved in activ it ies associated with the PMN substances and may reasonably be exposed to the PMN su b stances; (4) Existing exposure monitoring data for workers who are involved in activi ti es associated with the PMN substances and may r easonably be exposed to the PMN substances that
arc collected during the manufac ture or process in g of the PMN substances; (5) Records r eq uired by the Recordkeeping section of this Order; and / or,

### - 31 - (6) Any other information reasonab ly related to determining compliance with this Order
or conducting an inspection f or that purpose.
(b) Company's Response. The Companies shall respond to such requests within a reasonable period of time, but in no eve nt 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 reasonab ly accurate and detailed answers to all of EPA's reques ts.
(d) Confidentia l Business Information. Any Confident ial Business Informa tio n ("CBI") that the Compan ies submit to EPA pursuan t to paragraph (b) sha ll be protected in accordance with §14 ofTSCA and 40 CFR Part 2.

V . S U CCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope
. This section sets forth the proced ures by which the Co mpa ni es' rig h ts and obligations under this Order may be transfe rred when the Com pan i es tra nsfer it s int erests in the PMN substances, inc lud ing the right to manufact ure th e PMN s ub stances, to ano th er perso n
ou tside the**Compani~s** (the "S uccessor in In te r es t").
(b) Relatio n of Transfer Date to No ti ce of Co mm enceme nt (" N OC").- 32

- (I) Before NOC. If the transfer from the Companies to the Successor in Interest is effect ive before EPA receives a notice of commencement of manufacture or imp ort ("NOC") for the PMN**subs ance~**  from the Compan ies pursuant to 40 CFR 720.102, the Succ essor 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 s tatute to incl ude import) of the PMN subs tan ces . (2) After NOC
. If the transfer f rom the Companies to th e Successor in Interes t is effec tive after EPA r eceives a NOC, the S uccessor in Interest shall comply with the terms ofthis Orde r and shall not be requi r ed to submit a new PMN to EPA.
(c) Defi niti o ns. The following definitions apply to this Succe ssor Liability section of the Order: (I) "Successo r in Interest" means a person outside the Companies who has ac quired th e Compan ie s' full intere st in the ri ghts to manufacture the PMN s ubstances, including all ownership rights and legal liabilities, through a tran sfer document s igned by the Compani es, as transferor, an d the Successor in Interest , as transferee. The term excl ude s persons who acquire less than the full intere s t of the Companies in th e PMN substances, such as a licensee who has acquired a limited lic ense t o the patent or man uf ac turin g ri ght s assoc iated with th e PMN
su bstances. A S uccessor in Interest must be in co rp orated, licensed , or doing business in the United States in accordance wi th 40 CFR 720.22(a)(3) and 40 CFR 720.3(z). (2) "Transfer Document" m ea ns the lega l inst rument(s) u sed to convey the interests in th e PMN substances, including th e ri gh t to manufacture the PMN substa nces. from the Companies to the Successor in Intere s t.- 33- (d) Notices. ( 1) Notice to Successor in Intere st. On or before the effective date of the transfer, th e 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 bu s iness days ofthe effective date of the transfer , the Companies shall, by r egis tered mail, subm it the fully executed Not ic e 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 Co mpani es to the Successor in Interes t.
(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 s hall be liable for compliance with the requirements of this Order effective as of the date of transfer. (3) Nothing in this section shall be const ru ed to prohibit th e Agency from taking enfo r cement action against the Companies after the effective date of the transf er for actions- 34- taken, or omissions made, du ring 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
sec ti on of this Consent Order requires th e Companies to subm it test data to EPA at a spec ified production volume ( " test trigger'·), the aggregate volume of the PMN substances manufactured (defin e d by statute to include import) by the Companies up to th e date of transfer sha ll count towards the tes t trigger app lic able to the Successor in Interest.



### VI. MODIFICATION AND REVOCATION OF CONSENT ORD ER 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 envi ronmental r elease of , the PMN substances , to modify or revoke substant ive provisions of this Order. The exposures and risks identified by EPA during its review of the PMN substances and the information EPA determ ined 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 O rd er, EPA will cons id er
all relevant information availab le at the time the Agency makes th at determinat ion, including, where approp riate, any r eassessme nt of th e test data or other information that supports the findings in this Order, an examination of new test data or other information or analys is, and any other r e levant in format ion.

### - 35

- EPA will issue a modification or revocat ion i f EPA determines that the activities proposed therein will not present an unre aso nable risk of injury to hea lth or the e nvironment and will not result in sign ificant or substantial human exposure or substantial environmental release in the absence of data suffici e nt to permi t a reasoned eva luation of the health or e nvironment a l effects of the PMN su bstances. In addition, the Comp anies may petiti on EPA at any time to make oth er modificati ons to th e language of thi s 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 Ord er as issued.

### - 36- VII. EFFECT OF CONSENT ORDER 

### (a) Waiver. By consenting to the entry of this Order, the Companies waive their ri gh ts 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 en d of the review period pursuant to section S(e)(l)(B) ofTSCA, and to challenge the validity of this
. Order in any subsequen t ?Ction
. Consenting to the entry of this Order, and agreeing to be bound by its terms, do not constitute an adm ission by the Compan ies as to the facts or conclusions underlying the Agency's determinat ions in this proceeding
. This wa ive r does not affect any other rights that the Comp anies may have under TSCA.
(b) CBI Brackets. By signing this Order, the Companies represent that it have carefully reviewed this document and hereby agrees t hat 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 Chemica l Control Division Office of Pollution Prevention and Taxies·

# [~-**·- ·-** **··-·** Name: [ Title: [ Company: ] 

### J ]

## _LO

# ~~()/;4 

# L J Date/ ' 

# --·· ] Name: [ 

### Title: [ ] Company: [ ]

### A TTACHMENT A D

EF I NITIO N S Note: The allached Order may not contain some of the terms defined below. "C hemical name" means the scientific designation of a chemical substance in accordance with the nomenclature system developed by the Chemica l Abstrac ts Serv ice's rules of nomenclature, or a name which will clearly ide ntify a chemical substance for the purpose of conducting a hazard evaluation. "Compa ny'' means the person or persons s ubject to thi s Order. "Commercial use " means the use of a chemical substances or any mixture containing the chemica l subs tance in a commercial enterprise providing saleable goods or a service to consumers (e.g. a commercial dry cleaning establishment or painting contractor). "Commo n name " me an s any designation or identification s uch 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 temporar y household or residence, during recreation, or for any personal use or enjoyment. "Co n sumer product" m eans a chemica l s ub s tance 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 rec re ation. "Con tainer" means any bag, barrel , bottle, box, can, cylinder, drum , re act io n vessel, s torage tank , or the li ke that contains a hazardous chemical. For purposes of thi s sec tion , pipes or piping systems, and engines , fuel tanks , or other operating systems in a vehicle , are not considered to be co ntainer s. "Co ntract Manu facturer" means a person , outside the Compani es, who i s authorize d to manufactu re (de fin ed by statute to include import) the PMN substance und e r the conditions speci fied in Part II of this Consent Order and in the Consent Order for Contrac t Manufacturer. "Final Formulat ion of th e PMN substance" means the formulated dispersion of the PM N subs tance in the form in which it is sold to customers outside th e Compa nie s or transferred to a different business unit within the Companies. The term does not include intermediate dilutions of the PMN subs tance that are intended only for use with in the Co mpanies for further dilution · prio r to sale.

" ld en tity" means any chemical or common name used to identify a chemical subs tance 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 pe rson 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 Formu lations of the PMN substance" means a common intermediate PMN formulation, as it exists when first produced and isolated after the polym er 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 mat erial safety data sheet, the written listing of data for the chemical substance. "Non-enclosed process" means any eq uipment 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 ma y occur. "Non- industrial use" means use other than at a facility whe re 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.

" Proc ess s tream" means all reasonably anticipated transf er, 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 protoco l , or the Good Laboratory Practice Standards at 40 CFR Part 792 withou t prior or subsequent Agency approval that prevents a reasoned evaluati on 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 incon sistent, or otherwise insufficient to permit a re asoned 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 phys ic ally and chemica ll y suitable for long-term containment of the 

### PMN substance, and from wh ich there wil l be neither human exposure to nor environmental release of the 

### PMN

-substance during transport and storage . "Use stream" means all reasonab ly anticipated transfer, flow, or disposal of a chemical subs tance , regardless of physical state or concentration, through all intended operat ions of industrial, commercial, or consumer use. "Waters of the United States" has the meaning set f011h in 40 CFR 122.2
. "Workplace " means an establ i shment at one geog raphic location containing one or more work areas.Company (Transferor) 

### ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONT ROL ACT SECTION S(c) 

### CONSENT ORD E R

PMN Number
1. Transfer of Manufacture Rights. Effective on , the Companies did sell or otherw i se transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture of the above -referenced chemica l substances, which was the subject of a premanufacture notice ("PMN") and is governed by a Consent Order issu ed by th
. e U.S. Environmental Protection Agency ("EPA") under the author ity 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, al l actions or omiss ions governed by the apjJl icabl e Consent Order limiting manufacture, processing , use, distribution in commerce and disposa l of th e PMN s ubstances, shall be the responsibility of the Successor in Interest. Successor in Int erest also certifies that it is incorporated, licens ed, or doing business in th e 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 th e PMN substances(s). Where "reasse rts" or " relinquishes" is indicated, that des ignation shall be deemed to apply to all such claims. Where "mod ifi es" is indicated, such modification shall be expla ined in detail in an attachment to this Notice ofTransfer. Information which has bee n previously disclosed to the pub lic (e
. g., a chemical identity th at was not claimed as CBI by the origina l submitter) wou ld not subsequently be e ligible for confidential treatment under this Notice of Transfer.B-2 NOT I CE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER (continued ) Company (Tra n s feror) PMN Num ber
Signature .of Authorized Officia l Date
Printed Name of Authorized Offic ial
Title of Authorized Offic ial

S u cce sso r in Int ere s t
Signature of Authorized Officia l Date
Prin ted Name of Atithorized Offic ial
Title of Authorized Official
Address City, State , Zip Code

### B-3 NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER (co ntinued)

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