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TINITED STATHS HNVIRONIVf ENTA L PROTECTION AGENCY

OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF A NE\ry CHEMICAL SUBSTANCE

PENDING DEVELOPMENT OF INFORMATION

In the matter ofi

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Premanu facture Noti ce Numb er:

P-13-0568

CONTAINS NO

CB of'/*',

Consent Order and Determinatisns Supporting Consent Order

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TABLE OF CONTENTS

Prealrrble

I. Introduction

H. Surnmary of Terms of the Order

III. Contents ofPMN

fV. EPA's Assessment of Risk

V. EPA's Conclusions of Law

VI. lnfonnation Required to Evaluate Environmental Effects

II. Terms of Manufacture, Processing, Distribution in Commsrce, Use, and Disposal Pending

Submission a:rd Evaluation of Information

HL Recordkeeping

IV. Successor Liability Upon Transfer of Consent Order

V, Modifisation and Revocation of Consent Order

VI. Effect of Consent Order

Attac,hffent A - Definitians

Attachment B - Notice of Transfer of Consent Order
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PREAMBLE

I. INTRODUCTION

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

260a(e)), ths Environmental PrCItection Agency ("EPA" or "the Agency") issues the attached

Order, regarding premanufacture notice {*FMN") P-I3-0568 for the chemical substance

J f'the PMN substance') submitted by ("the

Company"), to take efTest upon expiratioa of the PMN review pe,t{od. The C*mpar}y submitted

ths PMN to EPA pursuant to $ 5(a)(1) of TSCA and 4S CFR Part 720.

Under $ 15 of TSCA, itis unlawful foranyperson to fail orrefuse to complywith any

prnvision of $ 5 or any order issued under $ 5. Violators mey be subject to varjous penalties and to

both sriminal and civil liability pursuant to $ 16, alrcl to specific e,nforcement and seizure pursuant

to $ 17. In addition, chemical substances subject to an Orderissued under $ 5 of TSCA, such as

this one, are subject to the $ 12{b} sxpoft notice requirememt.

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

(a) Iabel the PMN substanee and provide Material Safety Data Sheets (*MSDS") and worker

training in accordance with the provisions of the Hazard Communication Frogram section;
l-v

{b) not use the PMN substance other than as

applications

enhanced oil recovery

(c) distribute the PMN substnnce only to a person who agrees to follow the same restrictions and

to not further distribute the PMN substance until it has been partitioned into oil or petrolerun

streams following Bss as J enhanced oil resovery applications;

(d) comply with the Release tn Water provisions; and

(e) maintain certain records.

ilI. S.f),lTlpNTS p,H*,rF{N

By si'gning this Order, the Comlleny reprsssnts that it has caref'ully reviewed this document and

agrees that all information herein that is clairned as confidential by the Company is correctly

identified within bracksts and that any information that is not bracketed is n*t claimad as

confidential. To make this document available for public viewing, EPA will remove only the

infbmratiou contained within the brackets.

{hu{'1-tlqfltir*,Bu*ifief-q Inlbnnation Claims {Braek*tett iii-tlte Fre*mlile .n$dQ{dq}Tl:

Chemical identity, Cornpany Name, Production Volume, IJses, Prr:cessing infonnation
ehqmis.+l ld*rrlity;

Generic: benzenesulfonic acid, dimethyl*, alkyl derivatives, scdium salt

J enhanced oil recovery applications

Testleta $ubmitted yith the PMN:

e Biotic Degradation (Modified Sturm Test) Evaluation, In An Aqueous Medium, of the

"Ultimate" Biodegradability on an analog

. Salmonella-E. Colillvlamrnalian Microsome Reverse Mutation Assay

r Determination of Ko, Coefficient Following OECD Guideline 121

I FTIR spectnrm of the PMN substance

e Acute Dermal Toxicity Study in Rabbits

I Skin Sensitization Study in Guinea Pigs

IV. EPA',S ASSESSMEry qF.'Rr.SH

The following are EPA's predictions regarding the probable toxicity and environmental

releases of the PMN substance, based on the infonnation currently available to the Agency.

Enviroryn eFtai Eff,ects Summ ary :

Based on test data on the chemical substance itself, EFA identified the following c,oncentrations of

concsrn:

Chronic (20 days of exceedance or greater): 4 part per billion ("ppb")

Acute (less than 20 days of exseedance): 84 ppb

Human Health Effects Surnmary:
t71

Absorption is poor from the skin, moderate ffirm the GI tract, and good from the lurrg (analog).

Concern for surfactant effects on the lung; cun*siun ta eye, mucous mernhranes and lung based on

surfactant properties of the compounds and *nalogues. Rabbit dermal study indi*ated potential for

skrn rmtatron.

Environmental Relea*g Slrurr$ary:

Fluring the initial reyiew of the PMN that applied gener{c engineering $cenarios published by EPA

relevant to the notified use, EPA assessed the follcwing rel.eases and expasurfi$ af the PhfN

substance.

Manufacture Processing/[Jse

# Sites I I

Workers

{#lsite}

I I

Exposure

(days/year)

I I

Dermal Expasure

(mg/day)

I I

Inhalafion Exposure

(mg/day)

r I

Drinking lYater

Exposure (mglday)

I acute

chronic

Iacute

chronic

Releases

{days/year}

I I
vr-1

Release to Tfater

{kglday}

I I

Surface Water

Concerrtration fupb)

Uptol Uptol

Days Exceeding

Concern Level

I 50

As part of this Consent Order, the Company has agreed to limit any predictable rlr purposeful

relcase of the PI\{N substance, or any w.aste stream from manufacturing, prccessing, and use

containing the PMN substance, into the waters of the United States thatwould result in surfaoe

water concenhations exceeding 4 parts per bitlion f'ppb'o), when calculatecl using the methods

descrihed in 40 CFR ?21.91. Except for quantities of the PMN substance that have partitioned into

oil or petroleum streams following uss as J enhanced oil recovery

applications, the Company shall distribute the Ph4N substance outside the Company only to a

psrson who has agreed in lwiting prior to the date of ttistribution, to, among other requirements, to

also abide by this water release trigger and shall maintain such agreements on fiIe for inspection by

the Agency.

Y. EPA'S C0NCLUSIO$$-q.F L.S.:H

The followfng findings constitute the basis of the Consent Order:

(a) EPA is unable to determine tte potential for ecological toxicity and envirorunental fbte from

hurnan health afid environrnental release of the PMN substance. EFA therefore ccncludes,
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pursuant to $ S(e)(lXAXi) af TSCA, that the information available to the Agency is iusufficient to

permit a reasoned evaluation of the environmental effests of the FMN substanee.

{b) Xn light af the potential risk of ecological toxicity and human health posed bythe uncontrolled

manufhcture , processing, distribution in cnmmsree, use, and disposal of the PMN substance, EPA

has consluded, pursuant to $ 5(eXI)tAXii)(I) of TSCA, that uneontrolled manufacture processing,

distributian in commerae! use' and disposal of the PMN substance may prescnt an unreasonable

risk of rnjury to the envir*nment.

YI. IIi-TS RMATI qi'{ RE OTJIRE il T q PY. A LUATE ENYI"tsOI{M 4N T"A...t E FTSqTfi

Trisgered Tes[ing, The Order prahibits the Company fram exceeding * specified

production volume unless the Conrpany suhmits the information described in the'Iesting section rlf

this Order in accordarrce with the conditions spe*ified in the Testing section.
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P-ffi E

rffi UHffET} $TATES ENURSHIT4ENTAL FROTECTION AGENCY

WASHINGTON, D,C" 2fi4$O

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CONSENTORDBR

(a) $copE. The roquirements of this Order apply to all commercial manufacturiug, processing,

distribution in commercc, u$s and disposal of the chemical substance

OFFICE QF CHEMICAL SATETY

A}.I D POL LUTION PREUEN TIOi{

("the PMN substance") in the United States by the (*'the Comparryo'), except to

the extent that thase activitins ars sxempted by paragraph (h).

{b) Exernptians. Manufacturing, processing, distribution in commercs} use and disposal of the

Fl\dhf substanse is exempt from the requirements of this Order (except the requirements in the

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

extent that (l) these activities are conducted in full con:pliance with a1l applicable requirements of

the following exemptions, and (2) such compliance is documqnted by appropriate recordkeeping as

required in the Recordkeeping section of this Order.

(1) Export, tlntil the Cornpany begins comrnercial manufacture of the PMN substance far

use in the United States, the rcquirements of this Order dr: not apply to manufacture, processing or

lnternet Addre*s (URl.] ' http:liwww epa gov

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rtistrihution irr coffiffi{rrce of thc P}vIN suhstance solely fbr export in accordclnce withTSCA

g g 12(a.) and I 2(b), 4ff CFR 7?,fr ^3{s) and 40 CFR Part 707. However} once the Campeny begiris to

manufuuture the'llh,tN substauce foruse in the ljnited Statcs, no furlhsr activitybythe Company

invalving the IIMN substance is exeinpt as "saleiy for export" eyen if some amount of the FfuIN

substance is later *xport*d. At thnt 1:oint, the requir*ments of this Orcter epply ta al} activities

associated with thm PMN substance while in the territory of the United States" Priorto leaving

U.S. tentt*ry, e\reil th*se quantities or hatches of ths PhdN substilnce that are destir:ed for export

are subj*ct to terrns of the Order, and count towards any production volulne test triggers in the

Testing section of thi.s Ortter,

{2) Researcli & I}evelopment {"R&D"}. The requircments of this Order do not apply to

manufacturing, processing, distrihutior: irr cnrnmorfis] use aud disposal of the PMN substancs in

srnall quantities s*lely fhr resr:arch and clevektprne.nt in accordance lrritlt TSCA $5(hX3), 4S CI;R

?20.3(cc), ffid 40 CFR 72il.36. The requirernents of this Clrder also do not applytcr

manufacturing, pr'*r:essing, distributir:n in commerse: use a*d disp<lsal af the PMN substance

when rranufactured solely for non-comntercial research and clevelopm*nt per TSCA $5(i) and 40

cr?R 720.30(i).

(3) Bypr*ducts. The requirements *f this Order dn not apply to the PMN substance whsn

it is pruduced, without separate coffimerci*l intent, only as * "byprodu*t" as defined at 40 CFR

7?0.3(d) aud in t:ompliance with 4S CFR 730.3ff(S),

ia) No Separate Con:mercial Purpose. The requirements ol'this Order drl not &pply to the

PI4N suhstance when it is r::anufacfured, pursnant to any of the exemptions in 4il Cl"-R 720.3ilth),

with no cornffierci*I purpos* separate fiom the substance, mixturc, or *rticle of which it is a part.
*3

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

when it is imported as part of an'oarticle" as defined at 40 CFR ?20.3(c) and in compliance with 40

cFR 720.22bX1).

(6) Partitioned. The requirements of this Order do not apFly to quantities of the PMN

substancethathavepartitionedintooiIorpetroleumstreamsfol1owinguseu'f,

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enhanced oil recovery applications.

(d Automatic Sugpgt. If the Company has obtained for the PMN substance a Test Market

Exemption f'TME") under TSCA $s(hXI) and 40 CFR 720.38 or a Low Volume Exemption

("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA $5(hX4) and 40 CFR

723.50{c){l} and (2) respectively, auy such exemption is automatically rendered null and vaid as

of the effective date of this Consent Order.
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TL TERMS OF M4*I$qEACIURE. PROIESSING.

$IS,TRIBUTTON rN COMMERCE. USE. AND qISPOSJIL

pENprNG SuBMrsjrrpr\ 4,I{il EYAI,UATIO}{

9H,:mFsEl%IrO$

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The Company is prohibited from manufactudng, processing, distributing in commerce,

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

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

environmental effects of the substance, and the completion of EPA's review of, and regtlatory

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

T]ESTING

(a) Section 8(e) R.ppprtlng, Reports of infbnnation on the PMN substance which reasonably

supporls the conclusion that the PMN substance presents a substantial risk of injury to health or the

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

appropriate PMN identification number for this substance and contain a staternent that the

substance is subject to this Consent Order. Additional information regarding section 8(e) reporting

requirements can be found at wwrv.epa.gov/oppt/tsca8e.

(b) Notice o_f Study $cheduliqg. The Company shall notif-v. in writing the EPA Monitoring

Assistance and Media Programs Divisio n {2227A), Office of Enforcement and Compliance

Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.'Vf.,

Washinglon, D.C.20460, of the following information within 10 days of scheduling anysfudy
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requirsd to be perform4 pr*oant to this Order, or within I5 days after the effective date of this

Order, whichever is late,r:

(I) The dste when the study is scheduled io cofiutrence ;

{2} The narn6 and address of the laboratory which urill conduct the study;

(3) The name and telephone numbm of a person at the Compaay or the laborato.ry whom EPA

may coutact resarding thE study; an4

(4 The appropriate PMN identificatiou number for eash substance and a statemeut that the

substance is *ubject to this Consent Ordsr.

(c) \, Gopd l*aloratory Pra&e_$tBqdardB and Tgst Prptocol$. Each study performed to address the

risks identified in this ffier urusi be conduc-{ed according to TSCA Gobd Lahoratory Pragtics

Standards at 40 CFR Pert ?p2 and using mefhodologies generally asceptod in the relevant

scientific comnnrnity at the time the study is initiated. Befsre stnrting to conduqt ary *tudy thut

rvill use a modified version of a publisficd test guideline, the Coqpany uust submit writte,u test

protocols to EPA for review (submission of uritten test protocols is optional for.tests that are to be

coadycted using urunodified published test giridelines)- Protocols must be submitted as a srryport

docrrment for the PMN, using the procedures set out io Ot CFR 72fi.41. EBA rvill respond to the

Compauy rtrithh 4 weeks of ressiying the unitte,n protocols. EPA retrisw of a test protocol does

not mean pe-acceptance of teet reflrlts.

(d) Trisege4 Tp-qfine Reqlq{qgeg.tp. 

-The 

Compaay is prohibited from mauufacturing the PMN

substance at volurnes greater than I.QL9.5-00 kg or for a period louger thsn 2 years, 2 months after
*6

the Notice of Commencement f 'th* production limit"), unless the Company condusts the

following studies on the PMN substance and submits all final reports and underlying data in

accordance with the conditions specified in this Testing section.

Production Limit Study

Fish early life stage test

Daphnid ehronic toxicity

test

Test,Gqideline

0PPTS 850.r400

0PPTS 850. r 300

(e) Test Rqports. The Company shall; (l) conduct each study in good faith, $rith due care, and in

a s*ientifically valid marulsr; {2) prornptly fumish to EPA the results of any interim phase of each

,studyi and (3) submit the final report of each study (with an additisnal sanitized copy, if

eonfidential business infonnation is involved) and all urdertying data (*'thE report and data") to

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

submitted as a support document for the PMN, using the procedures set out in 40 CFR 72A.40.

The final report shall contain the contents specified in 40 CFR 792.L85. Underlying data shall be

submitted to EPA in accordance with the applioahle "Reportirg," "Data and Repotting," and o*Test

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

Order, the word "should" in those subparagraphs shall be interpreted to mean *shall" to make clear

that the submission of such infarmation is mnndatory. EPA will require the tubmission of raw

data such as slides and laboratory notebooks only if EPA flnds, on the basis of professional

judgment, that an adequate evaluation of the study camnot take place in the absence cf these items.
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(f; Testing WaiVgg.S, The Company is not reguired to conduct a study specified in paragraph td)

af this Testing section if notified in writing by EPA that it is unneees.$ary to conduct that study"

(g) EguivgcAl Datq, If EPA finds that the data generated by a study are scientifically equivocal,

the Company may continue to nr*nufacturethe PMN substance beyond the applicahle production

lirnit" To seek relief fi'om any other restrictions of this Order, the Company may make a second

atternpt to obtain unequirrocal data by reconducting the sfudy under the conditions specified in

paragraphs (b), (c), and (e) (except that the study may be submitted after reaching ttre applioable

production limit). The testing raquirements may he modified, as neces.sary ta permit a reasoned

evaluation cf the risks presented by the FMN suhstance, only by mutual consent of EPA and the

Company.

{h) EPA -Determinatiop of Invalid*Data.

(1) Except as described in subparagraph (h[z), ifl within 6 weeks of EPA's receipt of a

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

a study are scientifically invalid, the Cornpany is prohibited liom fumher manufucfcre of the PMN

substance heyoncl the applicable praduction limit.

(2) The Corupany may continue to manufacture the PMN substance beyond the applicable

producti*n limit only if so notified, in writing, hy EPA in response to the Compaily's compliance

with either of the following subparagraphs (hX2Xi) or (h)(z){ii).

(i) If there is sufticient time to reconcluct the study in compliance with paragraphs

(b), (e), and (e) hefore exceeding the pruduction }imit specified in paragraph (d), the Company
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mfly reconduct the study. lf there is insuffi$ient time to reconduct the stucly in compliance with

paragraphs (b), (o), antl (e) betbre exceediug the production limit specified in paragraph (d), the

Company may exceed the production limit, but must r:therurise comply rvith paragraphs (b), (c),

and {e), and shall submit thereport and datata EPA within areasonableperiod of time, all as

speuified by EPA in the notice descrtbed in subparagraph (hXU, EPA will re.spond to the

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

(ii) The Cormpany mny, within 4 weeks of receiving from EPA the notice described

in suhparagraph (hxl), submit to EPA a wriften repofi retuting EPA's finding. EFA will respond

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

(il Comuanv Determination of [nvalid Data.

{1) Except as described in subparagraph {iX?}, if the Companybccomes aware that

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

prevented, development of scientifically vatid rlata under the conditions specified in paragraphs (c)

and (e), the Cornpanyremains prohibited from further manufacture of the PMN substance beyond

the applieable production limit.

(2) The Cornp&ny mny submit to EPA, within 2 weeks of first becoming aware of such

circumstances, a written statement explaining why circumstances clearly beyond the.control rrf the

Company or lahoratcry will cause or have caused developrnent of scientifically invalid data. EPA

rryill notiff the Company of its response, in writing, rnithin 4 weeks of receiving the Company's

repart. EPA's written rssponse mey either:
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(i) allow the Company to continue to rnanufacture the PMN substance beyond the

applicable production limit, or

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

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

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

paragraph {d}. If there is insuffi.eient time for the Company to comply rvith paragraphs &), (c},

a:rd (e) before exceeding the protluction limit specified in paragraph (tl), the Cornpany may exceed

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

the report and data to HPA within a reasonable period of time, all as specified by EPA in the notice

described in subparagraph (il(z). EPA will respond to the Compffiy, in writing, within 6 weeks of

receiving the Company's report and data, as to vrhether the Company may continue to manufacture

beyond the applicable production limit.

U) Unreaq-olrahle &isk. EPA may notify the Company in writing that EPA finds that the data

gcnerated by a study are scientifically valid and unequivocal and indicate that, despite the terms of

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

or the environment. EPA's notice may specify that the Company rurdertake certain actions

concerning further testing, manufacture, processing distribution, use an#or disposal of the PMN

substanoe to mitigate exposures to or to better oharacterize the risks presented by the PMN

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

manufacture, processing, distribution, use and disposal of the PMN substance, unless either:
,1*

{1) witlrin 2 weeks from receipt of the EPA notice, tlre Company cornplies with such requirements

as the natice specifies; or

{2} within 4 weeks from receipt of the EPA nctice, the Company submits to EPA a written report

refuting IiFA's finding and/or the appropr{ateness of any additional requir*ments imposed by

EPA. The Company rnay continue to rnanufactur*, process, distribute, use and dispose of the

PMN substance in accordance with the terms of this Order pending EPA's response to the

Company's rvritten report, HPA will respond to the Company, in r.vriting, within 4 weeks of

receiving the Companyos report. Within 2 weeks tlf receipt of EPA's rvritten re$ponse, the

Company shall comply with any requirernents imposed by EPA's respon$e sr cease all

manufaeture, prccsssing, distribution, use and disposal af the PMN substanee.

(k) Other Requirements- Regardless of the satisfaction af any other conclitisns in this Testing

section, the Compaily must continue to abey all the tsrms of this Consent Order until otherwise

notif,red in writing by EFA. The Company mey, hased upon submitted test data or other relevant

infbrmation, petition HPA to modi$r or revoke provisions of this Consent Order pursuant to Part

VL of this Consent Order.

HAlrARp CO ftteil Ufirx SATI pIT, F,.EQS RAM

(a) Yltitten Hazard CqilruHRiq+lifin Prggram. 'I'he Company shall develop and implement a

wriffen hazard sommuilication program for the PMN suhstance in eaclr workplace. The written

prosram will, at a miuimuffi, describe how the requirements of this section f+r labels, MSDSs, and

other forms of warning rn*terial will be satisfied. The Company must rnake the written hazard
- 1l_

coffimunication program availablel upofl request, to all employees, contractor ernployees, and their

designated representatives. The Cornpany may rely on an existing hazard comrnunication

programo including an existing prograffi established under the OSHA Hazard Communication

Standard (29 CFR 19 t 0. 1200), to comply wifh this paragraph providcd that the existing hazard

cofinffiunication program satisfies the requireanents of tJris section. the writter: program shall

include the followi*g:

{U A list of cherrical substanoe known to be present in the work err,a" which are subje+t to

a TSCA seetion 5(e) consent order signed by the Company or to a TSCA $ection s(aXZ) SNUR at

40 CFR Prr:t721, subpart E. The list must be maintainett in each wark area wherc the PMN

substance is known to be present and must use the identity provided on the MSDS fbr the

substance required underparflgraph {*) of this secti*n. The list maybe compiled forthe workplace

or for individual wor* &rsas, If the Company is required either hy another Order issued under

sectian 5(e) ofTSCA, arhyaTSCA section 5(aX2) SNUR at40 CFR Pilrr??I, subpart E, to

rnaintain a list of substance, the lists shall be combined rvith the list under this subparagraph.

(2) The methods the Company will use to inform employees of the hazards of non*routine

tasks involving the PMN suhstance (e.9., cleanirrg of reactor vessels), and the hazards associated

with the PIvIN substance contaiued in unlabeled pipes in their wark area.

{3} The rnethods the Campany wilt use tc infarm contractors of the presffi}ce of the PMN

substance inthe Comparry's workplace and of the provisions of this Order if employnes of the

contractor lvork in the Company's workplace and are reasonably likely 1o be exposed to the PMN

substance while in the Company's workplace.
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ft) I.abeling.

(l) The Company shall ensure that eash container of the substance in the workplace is

laheled in *ceordancs with this subparagraph (bXU.

(i) The label shall, at a miniurum? contain the following information:

(A) A statement of the health hazards(s) and precautionarT rrleasure(s), if

any, identified either in paragraph (f) of this section orbythe Company, for the FfuI-\tr suhstance.

(B) The identity by which the PMN substance may be commonly

recognized.

(C) A statement of the enviroumental hazard(s) and precautionary

lneasure(s), if any, identified either in paragraph {f} of this section, or by the Cornpany, far flre

FMN substance.

(D) A statement of exposure and precautionary Ineasurs(s), if any,

ide*tified either in paragraph {f) of this section, or by the Company, for the PMN substance.

(ii) The Company may use signs, placards, prosess sheets, batch tickets, operating

procedures, or other such written materials in lieu of affixing labels to individual stationary

process cont*iners' as long as the alternative method identifies the containers to r.vhich it is

applicable and ssnveys infcrmation specitied by subparagraph ft){l)(i} of this section. Any

written ruaterials must be readily accessible to the e.mployess in their work aress throughout eaoh

work shift.

(iii) The Cornpilny need not label portable containers into which the PMN

substance is transferred from labeled containers, and which are intended only for the imrnediate

use of the employee who performs the transfer.
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(iv) The Company shall not remove or deface an existing label on containers of the

PMN substance obtained from persons outside the Company unless the container is immediatBly

rc-lahcled with the information specified in subparagraph (t XlXi) of this section.

(2) Tlhe Company shall cnsure that each container of the substance leaving its workplace

for distribution in commerce is labeled in accordance with this subparagraph (bxz).

(i) The lahel shall, at a minimum' contain the following infonnation:

(A) The information prescribecl in subparagraph (b)(lXi) of this section.

(B) The name and address of the manufacturer or il responsible party who

can provide additional information on the substance for hazard evaluation and any appropriate

emergexcy procsdures.

(ii) The label shall not conflict with the requirements of the Ffazardous Materials

TransportationAct(18U.S.C, 1801 et.seq.)andregulation.sissuedunderthatActbythe

Department of Transportation.

(3) The label, or alternative forms of waming, shall be legible and promiuently displayed.

(a) The label, or alternative fbrms of warning, shall be printed in English; however, the

information ruay be repeated in other languages.

tS) If the label or alternative form of warning is to be applied to a mixture containing the

PMN substance in combination with any other substance that is either subject to another TSCA

section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40

CFR Part 721, subpart E, or defined as a "hazardous shemical" under the OSHA Hazard

Communication Standard (29 CFR 1900.1200), the Conrpany may piescribe on the label, MSDS,

or alternative form of r,varning, the measures to control worker sxposure or environmental release
,L4*

which the Company detennines provide the greatest degree of protection. However, should these

control measures differ from the applicable measures required under this Order, the Company must

seek a determination of equivalency for such alternative control measures pursuant to 40 CFR

'121.30 before prescribing thern under this subparagraph (bxs).

(6) If the Company becomes au/are of any significant new information regarding the

hazards of the PMN substance or ways to protect against the hazards, this new information must be

added to the label within 3 months from the time the Company becomes aware of the nerv

information. If the PMN substance is not being manufactured, processed, orused in the

Company's workplace, the Company must adcl the new information to the label before the PMN

substance is reintroduced into the workplace.

(c) M_at"erial Safety Data_ Sheets.

(1) The Company must obtain or develop an MSDS for the PMN substance.

(2) The MSDS shatl contain, at a minimum, the fcllowing information:

(i) The identity used on the container label af the PMN substance under this

section, and, if not claimecl confi.dential, the chemical and colnmon name of the PMN substance.

If the chemical and commofl names are claimed confidential, generic chemical names mustbe

used.

(ii) Physical and chemical characteristics of the substance known to the Cornpany,

(e.g., vapor pressure, flash point).

(iii) The physical hazards af the substance knorvn to the Company, including fhe

potential fbr fire, explosion, and reactivity.
-15

(iv) The potential human and envircnrnental hazards as sptlcified in paragraph (f)

of this section.

{v} Signs and spnptoms of exposure, and any medical conditions which are

expected to be aggtavated by exposuro to the PMN substance known to the Company.

(vi) The primary routes cf expos*re to the PMN substance.

("ii) Prccautionary rneasures to cantral worker exposurs and/or environrnental

release required by this Order, or alternative control measures rvhich EPA has determined under 40

CI,IR 72L30 provide substantially the sirme deglee of protection as the identified control measurss.

(viii) Any gerrerally applicable precautious for safe handling and use of the FMN

substancs which are known t<l the Company, including appropriate hygienic practices, protective

measurss during repair antl maintenance of cantaminated equipment, and procedures for respons$

to spills and leaks.

(ix) Any generally applicable control rneasilres whish are known to the Company,

such as appropriate engineering controls, work pr**tices, or psr$onal prutective equipment.

(x) Emergensy {irst aid procedures known to the Company.

(xi) The date of preparation of the MSDS or of its last revision"

(xii) The narne, address, and telephone,numbsr of the Company or another

responsible party who can prsvide additional infbrmation sn the chemical suhstance and any

apprcpriate emergenfiy pro*edures.

(3) If no relevant information is found or known for any givon category on the MSDS, the

Companymust mark thc MSDS to indicate that no applicable information was found.
- 1-6

(4) Viihere multiple mixtures cantaining the PMN substa*cc have similar compositions

(i.e., the chemical ingredients ars esssntially the sarne, but the specific composition varies from

mixture to mixture) and similar hazards, the Company may prqpare one MSDS to apply to all CIf

these multiple mixtures.

{5} If the Coml:any becomes aware of any significant new information regarding the

hazards of the PMN substance or wayr to protect against the hazards, this nerv infornation must be

added to the MSDS within 3 months from the time the Company becames aware of the new

information. If the PMN substance is not being manufactured, prs*essed, orused in the

Company's workplace, the Cornpany must add the fiew informatian to the MSDS before the PMN

suhstance is reintraduced into the workplace.

(6) The Company must ensure that persons receiving the PMN substance from the

Cornpany are provided an frppropriate MSES with their initial shipment and with the fimt shipment

after an MSDS is revised. The Company rnay either provide the MSDS with the shipped

containers or send it to the persCIn priar to or at the time of shipment.

(7) The Company nrust maintain a copy of the MSDS in its workplace, and must ensurc

that it is readily accessible tluring each work shift to employ$es when they are in their work arefls.

(8) The MSDS may be kept in any form, in*luding as operating pracedures, and may be

designcd to sover group$ of suhstance in a work area where it may be more appropriate to address

the poteutial hazards of a prficess rather than individual substance. However, in all cases, the

required information must be provided for the PMN substance and mu$t be readily accessible

during each work shift to employees wh.en they are in their rnork areas.
"L7

(9) The MSDS must be printed in English; horvever, the infonnation may be repeated in

other languages.

(d) Employee Inlbrmatigtlpn"d_Training, The Company must snsurs that employees are provided

with infannati+n and trai*ing on the PMN substance. 'Ihis information and training must be

provided at the time of each employee's initial assignment to a work flrsa containing the PMN

substance and whenever the Plvfi{ substance is introduced into the employee's *'ork area for the

first tirne.

(1) The information provided to employees under this paragraph shall in*lude:

(i) The requirernents ofthis sc*tion.

(ii) Any operatians in the work arsa w'here the Ph{N substancc is present.

(iii) The location and availahility of the writtsn hazard communication ptogram

required under paragraph (a) of this sectiou, including the list of substnnce required by

subparagraph (a){l} of this section and MfiDfis required hy paragraph {c} of this section.

(2) The training provided to employees shall include:

(i) Methods and observations that may be used ta detect the pr.esencs or release of

the PMN substance in or fron: an employee's work area (such as expclsure monitoring conducted

by the CompanS continucu$ monitcring devices, visual appoaranc$r or odor of the substance when

(ii) 'fhe potential human health and environmental hazards of the PMN substance

as specified in paragraph (f) of this section.
1_B

{iii} The measurss employess can take to protect thenrselves and the environment

from the PMN substance, including specific procedures the Cornpany has implemented to pratect

employees and the environment frorn exposure to the Fh{N substance, including appropriate rarork

practices' smergemcy procedures, personal protective equipment, engineering controls, and other

measurss to control rvorker exposure and/or environmental release required under this Order, or

alternative control measures rn hich EPA has determined under 40 CFR 72I3A provide the same

deppee of protection as the specified control measures.

(iv) The requirements of the hazard communication program developed by the

Com1:any under this section, including an explanation of the labeling system and tht hdSDS

required by this section and guidan$e on obtaining antl using appropriate hazard information.

(e) Dg Minimis Cancentratiqqs. The requirements of t]ris Hazard Communication sectian do not

applyto quantities of the PMN substance that ar"e (1) present in the work area only as a mixture

and (2J at a coneentration nat to exceed 1.0 percentby weight or volurne {0"1 petcenf by weight or

*olume if the PMN substance i.s identified as a potential carcinogen iu paragraph (f) af the Haeard

Comrnunisatinn Program section af this Order), This exemption is not available if the Company

has reason to believe that, during intended activities, the PMN substance in the mixture may be

recon$entrated above the 1,{} or ff,1 percent level, whichever applies. If this Order contains New

Chemical Exposure Limits provisions or Release to Water provisions that, respectively, specity a

NCEL concentration (.'TWA") or in-stream concentration {"N"} less than the de minirnis

concentration specified here, then this de minjmis exemption does not apply to those provisi+ns,
-19

fi) g ut+1..Hazard. trxposure* I'he

fbllorving human health and environrnental hazard and preeautionary statements shall aFFear on

each label as speeified in paragraph (h) and the IvISDS as specilied in paragraph (c) of this section:

(1) Envircnme,ntal hazard statements. These substance may be:

(i) toxic to fish.

{ii} toxic to aquatic organisms,

t2) Environrnental hazard preeautionary staternents. Natice to users:

ti) disposal restrictions apply.

(3) FJuman health hazard statements. 'I'his subsknce may causs:

{i} skin irritation.

(ii) ser{ous eye dan:rage.

(4i Hurnan hazard precautionfrry statements. When using this substatce:

{i) avoid skin contact.

{ii) avoitl breat}ring the substanc,e.

(iii) avoid ingestion.

(iv) use skin prctection.

(5) The human health, environrnental hazard and precautionary statement on the label

prepared pursuant to paragraph {b) of this section must be foilorved by the statement: "See the

MSDS for details""
20

MANTIT4.CIUBINq

(aXl) Prohibition. The Compflny shall not cause, encourags, or suggest the manufacture of the

PMN substance by any other p$rsoil.

(2) SgqSet following SNUR. Subparagraph (a)(1) sha]l expire 75 days after prornulgation

of a final significant new use rule ("SNUR'') governing the PMN substance under section 5{aX2}

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

seeking judicialreview of the SNUR. Ifthe Conrpanyis so notified, subparagraph (a)(1) shall not

expire until EPA nr:tifies the Comparly in writing that all Federal Court actions involving the

SNUR have heen resolved and the validity of the SNUR affirmed"

(3) NEfiegof $liUB. When EPA promulgates a final SNUR for the PMN substance and

subparagraph (ai(l) expires in accordance with subparagraph (aX2), the Company shall notify

each person whom it causes" ercour&ges or suggests to manufacture the PMN substance of the

existence of the SNUR.

(b}TheCompanyshalInotmanufacturethePMNsubstanceotherforusethanu*f

E] enhancect oil recovsry applications.

#PROCESSING

(a)TheCompanysha1lnotprocessthePMNsubstanceotherforusethan*E

- 

enhansed oil recovery applications.
F\ -t ' tJgrEE*

ta) T'he C*n:pany sirall not use the PMN subst*nce *ther th*n as

enhancrsd oil recovery applications.

PIE}FI:IITJT{{Try

(a)Er*:uthr@.}ioIaterthanthedatcr:fdistrjbution,th.eConrpffI1yghal1notifyin

writing flny p$r$an t* rn'h*rn it distributes the PMN suhstancc that, due to the issuancc of this

Conscrtt Ordr:r undsr section 5{c} of TSC:\, the FMhi substance is subjest to t}re export n*tilication

requircments of TSCA se*tion 12(b) and 40 CFR Fart 707 Suhpart D- Such nctico shall contain, in

thc fartrr in wtrich it nppears in this Consent Order, the fi*lh:wing infcrmation: (l] the Pil,IN

number, anct (2) either'(A) tho specific chemical iderrtity of the IIMN substance, or {B) if tke

specific chemical idcntity is +onlidential, the generic chernical identity.

(b) pj+tfihutjgu*kqguercenltu (i) Except fbr quantities af the Ph4N substzutce that have

partitioned into oil ur petrcleunr sheams frrllowing u$e as orrhzurcetl

oil recovery applications sr as provided in paragraph ic), the Campany shnll distrihute the PMN

sub*tancs outside the Company rnly to a person who has agreed in writing prior to the date of

rlistribution, t*:

(1) Notify in writing afty psrson to ruhom it dishihutes the FMN substance that, due t* the

issuanc* of this Consent Order *nder section 5(e) of TSCA, the PMN substance is suhject to thc

expott notificatian requirsments of "ISCA section I 2(b) arrd 4il {lFR Fart 707 Subpart I}. Such

ilotics shall *ontain, in the i-onn in r.vhich it *ppcars in this Ccnsent firder, the fbllowing
infomration: (1) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN

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

{2) Not further dishibute the PMN substance to any other person, other than for disposal,

except for quantities of the PMN substance that have partitioned into oil or petroleum streams

following use as enhanced oil recovery applications.

(3) Comply with the same requirements and restrictions, if ffiy, required of the Company

in the Hazard Communication Program section of this Order.

(4) Comply with the same environmental release restrictions, if any, required of the

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

(5) Not use the PMN substance other than as described in flre PMN;

(c) Tgurcs1fliv Transport and StoraBE Notwithstanding paragraph (b), the Company may

diskibute the PMN substance outside the Cornpany for ternporary transpcrl and storage in "sealed

containers" (defined for the pulposes of this Order to exclude tank kucks, tractor trailers, train

sars or other delivery vehicles with atiached tanks) provided the follor+'ing three conditions axe

met:

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

PMN substance ffiay be distributed only to the Company or a psrson who has given the Company

the written agreement required by paragraph (b).

(2) Any human oxposure or environmental retease resulting from opening the sealed

containers and removing or washing out the PMI.{ substance may occur only while the Ph$tr
sr.:'l:*ti.rn*e is in thr: pnss*.rsi*n allrJ c*ntnrl *f the {]nrrrp*ily {ir i} p*r$tin ,.vJr* hns givr:r.r th* C*nt1>a*y

thc r,vritten agre*mcut requirccl by paragraph (h).

(3) T'he sealed containers nrust be labeled in aocordanc* rn ith pnrilgreph {bX?) of the

Hazarrt Cammuni+ation Progranr section of this Orclcr.

(d) Ikql pte$t Nee-Ciompli rycq.

{l) H; at any time aI}er comrnencing distributiorr in coramLrlce of th* PhdN suhstauce, the

Cornpany obtains kno,*vlerlgc th*t a rer:ipient *r transparter of the substancfi hfis {hil$d to c*rm1:ly

rq,ith a:ry of the conditi$ns iipiioifiert in parirg::nph ib) oiltl:is llistributiun ser;tion or, after

subparagraph ib){z} e.xpires in accordancc with suhparagrap}r {e)il), }tits errgaged irr at sigrri'iicant

ilclv use of the PMN substance {as definerl in 40 CIiR Fart 721, Suhpart 11) without subrnitting a

significant new use notice to EPA, the Courlrany shall $sas6 suppiying the substanee ttr th*t

re*ipicnt, unless thc Comparry is ahle tr.r docurn*nt ea*h of the f'ollowing:

(a) TI:at the Compftny has, rvithin 5 working clays, nctified ti:e recipient in writing that the

rccipient ha-s failed to crrmply with any of the eanditions spscified in paragraph {b) of this

$istrihtrtion sectian, orhas *ngagccl in a significant ncrv use of the PM-tt{ suhstancc u,ithout

submittifig significant new use notices to EPA

(b) That, rvithin 15 working dn3rs of notitying the recipient af ths ililncompliance, the

Cornpany received Jrorn the recipient, in wriiing, a staternent' of assuranco thrt the recipient is

awsr$ of ths'ten::s of paragr*ph ib) of this Di.stribution scctiou and rvill compty rvith thos* tenn$,

*r is {rwnrc o{'the terms of the significarrt nerv use rules for the PMN substance a*d will n+t engage

in sigrrifica::t ner.v uses without suhmitting signifieflnt new'ust notices to HpA.
-24

(c) If, after receiving a staternent of assurflnoe from a recipient undcr subparagraph

(dxlXb) of this Distribution section, the Company obtains knowledge that the recipient has failed

to conrply with any of the conditions speci{ied in paragraph &} of this Distribution section, orhas

engagerl iu a significant nelv uses of the PMN substance without submitting a significant new use

notir:e to EPA, the Company shall cease supplying the PMN substance to that recipient, shall

notify EPA of the failure ta complp and shall resumc supplying the Ph'lN substance to that

recipient only upon wrritten notification from the Agency.

(2) If, at any time after sommencing distribution in commerce of the PMN

substance, EPA obtains knowledge (such as tlrrough a TSCA Section 1 1 inspectioa or .subpoena),

that a recipient of the substance has failed to cornply with any of the conditions specified in

paragraph ft) of the Distribution section or, after subparagraph ft)(2) expires in accordance with

subparagraph (e)(1), has engaged in a significant new use of the PMN substance (as defined in 40

CFR Part 721, Subpart E) rvithout subrnitting a significant nelv use notice to EPA, EPA may notify

the Company in rvritingthat, despite the terms of'this Order, EPA finds that the distribution in

commerce of the PMN substance rvill or may present an unrsasonable risk of injury to human

health or the environment. EPA's notice may speciff that the Company undertake c,ertain actions

concerning further testing, manufacture, processing, distribution, uss an#or disposal of the PMN

substance to mitigate exposures to better characterize the risks presented by the PMN substa:rce.

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

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

{a) '',r,ithin 2 weeks fram receipt of the EPA notice, the Cornpa$y complies with such requirements

as the notice specifi.es; or
t

(b) within 4. r,veelrs firm reccipt of the EPA notic*, th* CurnFirrly submits to HPA a lvritten

report refriting liPA's lindiug arrriior the appropriateness af any additianal aetiuns iniposed by

EPA. I'he l:PA will respond to the Compauy, in rryriting, r.vittriu 4 w$elcs of receiving the

Company's r:epofi. Within ? rvccks af rcc.eipt of EI'A's written response, th.c Company shall

cCIrnply r.vith any requirements imposeil by liFA's nr:ti*e or reviscd rcsponsc or, cease all

manuflacturc, processing, distr"ibution, use and disposal of the PM.\t substauce.

(e) Ssuse!Foll$ffug SILB. {l) Subparagraphs (bxz) and {d)i?.) of'tlris l}istrihutian sectio:r

shall expire 75 days after promulgation of a final SNtllts for thc PMN substance unrler .sectiou

5(ai(2) af TSCA, unlcss the Campany is notificd on ar belat'e ifu*l rlay o['an ar:tiort in a Fcderal

Court seeking judicial revierv of thc SNLfR" If the Cr:rnpany is so rrotified, subpalagraph (hXZ)

and (d)(2) o{'this Distributian section shall not expiri: unti} EPA notifies the Conrpany in writing

that all Federal Court ac.tions involving the SNI"IR havc heen resoh'ed and the validity of the

SNUR affirmed.

(2) WJren EPA promulgates a frnal SNUR for the PMN substance and suhparagraphs ib)(z) and

tdli2) of this Distributiou section expircs in accordance with subparagraph (e){l), the Cornpany

shall notify each person ta lvhom it distributcs the PMN substance of the *xistence of the SNURs.

Such notification must be in writing and must specifioally irrclude all liuitations cont$ined in the

SItfI-lRs which aro dufinecl as siggriflcant nerv u$es, and which would invake significant new use

notification tr Et'JA for the PIvIN sribstance. Such notice must also refiorence the publication of the

SNURs for this PhdN substance in either the.H"edel.Aleegiqtqr or the Code of Federal Rcgulations,

After promulgation of SNURs and expiration of suhparagraphs tbi(Z) anrl (d)(Zj, su*h Eotices
eb

may substitute for the rvritten agreements required in the introductory clause of paragraph ft); so

that, if the Company provides sueh notices to the persons to whom it distributes the PMN

substance, then the Cornpany is not required to obtain frorn such psffions the written agreements

specified in paragraph (b).

RELEASE TO WATER

This provision does not supersede or preflnpt any applicable federal, stats, and local laws and

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

Company is prohibited from any predictable or purposeful release of the PMN substance, or any

waste stream from manufacturing, processing, and use containing the PMN substance:

(lXa) Into the waters of the United States if the quotient from the farmula:

number of kilograrns/daylsite rel eased

x 1000 - N parts per billion

receiving stream flow (millian liters/day)

exceeds 4 parts per billion ("ppb"), when calculated using the methods described in 40 CFR

72l,gL However,40 CFR "lIL.g1(aX4) does not apply. Instead, if the waste stream containing

the PMN substance will be tr"eated using biological treatment (activated sludge or equivalent) plus

clarification, then the amount af PMN substance reasonably likely to be removed from the waste

stream by such trcatment maybe subtracted in calculating the number of kilograms released, No

more than 90 percent removal efficiency mey be attributed to such ffeatment.

(b) In lieu of calculating the quotient iu subparagraph (1)(a), monitoring or alternative calculations

may be used to predict the surface rvater concentration expected to result from the intended release
27-

nf the suhsturcc, if the monitoring pl.ocerlur'*s or r:alr:ulatiq:ns havr: bcc.n approved. for such pilq)ose

by IIPA. EPA will review and aut on a written request to approve monitoring procedurss or

altcrnative caiculations within 90 days atter such a request is reoeived. The Agency will infonn

the Cornpeny of the disposition of such requests in rvr:iting zurd, where a r{rquest is denied, will

expiairr thc reasons there'fore.

Irr. I$Hfr$ffimlls"flI&r

(a) lkgg1clg. T'he Cornpeffiy shall maintain thc lbllowing recorcis until 5 years after tht: clate they

arc crcatcd and slTall make thern avaikrble ti:r inspcction ancl copying by EPA. in accordanec rvith

section Il of TSCA:

(1) Exemptiong. Records rlocumenting that the Ph{N substance tlid in fact qualify lcrr any

on$ or more of the cxernptions described in Section I, Faragraph (h) of this Order. Such records

must satisfy all the statutory and regulatory resordkeeping requirements applioable to the

exeurption being clairned by the Company. Any amounts or batches of the PMN substance

eligible forthc export only cxcmpLion in Section I, Paragraph (bXl) of this Order arc excmpt fiom

all the requirements in this Recordkeeping section, if the Company rnaintains, for 5 years ftom the

date of their creation, copies of the export labcl and cxpoft natice to EPA, required byTSCA

sections I2(a)(1XB) and 12{b}, respectivelv. Any amounts or hatches of the PMN substance

eligible for the research and develaprnent exernption in Section I, Paragraph (hX2) of this Order

are sx$nlpt from all the requirements in this Recordkeeping section, if the Cotnpany rrraintains, for

5 yeeu's fi'om the date of their r:reaticn, thc recortls requiretl by 40 CFI( 720.78{h}" F-or atry
"28

amounts or batches of the Ph{tN suhstance claimed tr bc eligible for any other exemption described

irr Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating

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

but is exempt fiom the other recordkeeping rcquirements in this Rccordkeepir:.g secti*n;

(2) Records documenting the manufactur:e volume of the FMN substance and the

$orrssponding dates of manufhcture;

(3) ltecords dacurnenting the narnes and addresses (including shipment destination

address, if differcnt) of all persons outside thc site of manufacfut'e to whom the Cornpany dircctly

s*lls or tra:rsfers the PI,IN substance, the date of each sals or transfer, and the quantity af the

suhstance soltl or transfbn:e<l on such date;

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

{5} Records docunte*ting estab}ishn:cnt and implementatiou cf the hazard communication

progrern required by the Hazard Communication Program section of this Order;

(6) Copies of labelr required under the Harard Communication Program section of this

Order;

(7) Copies of htlaterial Safety fJata Sheets required by the Hazard Communication

Prugram sectian of this Ordu';

(8) Rer:ords dacumenting c*mplia*ce with any applicable mzurufacturing, processing? user

anrJ distribution rest*ctions iri the Manufacturing, Processing, Use, and Distribution ssctions af

this Order, including distributees' written agrssment to comply with the tristribution section of this

Order;
*29

(9) Recorrls documenting compliance with any applicable disposal requirements under the

Dispasal section of this Order, iacluding method of disposal, location of disposal sites, dates af

disposal, and votume of PMN substance disposed. Where the estimated di.tpasal volume is not

known to the Company and is not reasonably ascertainable by the Company, the Company must

maintain ather records which dernonstrate establishment and implem*ntatir:n of e program that

sn$ures compliance with any applicable disposal requirements;

(10) Resords do*umenting establishment and implementation of prccedures that ensure

compliance with any applicable rvater dischargo Iimitation in the Release to Water secti*n af this

Order;

{1U Copies of any Transfer l)ocumentri and notices requirecl by the Successor l-iahility

section of this Order, if applicable; and,

(12) The Company shallkeep a copy of this Order at eaeh of its sites where the PMN

suhstance is manufacfu red.

{b} Applicabilirv. 'lhe provisions of thi.s Re*ardkeeping Sectiorr are applicable only to activities

af the Cornpany end its Contract Manufacturer, if applicable, and not to activities of the

Cornpany's customsrs.

(c) OMB Control Nurnbsr. Under the Paperwork Reduction Act a:rd its regulations at 5 CFR Part

1320, particularly 5 CFR 1320.5(b), the Company is not required tn respond to this *'eollection ol'

infrrmation" unless this Order displays a currently valid contrcl number from the Offiee of
'30

ivlanagement ancl tsudget ("OMB"), a'nrt EIIA so informs the Company. The "collection of

information" required in this TSCA $5(e) Consent Order has been approved under currently valid

OMB Control Number 2070-0012.

rv. RE Q UEsrs roR PRE-INSJ'E CTIQII INTpRI,IAIIqIi

(a) EPA's R$_quest f.al Inforrnat'ign. Pursuant to section 11 of TSCA and 40 CFR 720J22, EPA

may occasionally conduct on-site compliance inspections of Cornpany fflsilities and conv$yancss

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

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

inspections. Such requests maybe written or oral. 'Ihe types ofinformation that EPA mayrequest

include, but are not limited to, the following:

(1) Expected dates and times when the PI!(tt{ substance rryill be in production within the

subsequent 12 months;

(2) Currcnt workshift schedulss for workers rnho are involved in activities assaciated with

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

(3) Curent job titles or categories for w'orkers who are involved in activities assoeiated

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

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

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

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

(6) Any other inforrnation reasonably related to determining cornpliance with this Order or

conducting an inspection for that purpose.
- 31.

(b) Cott-:pa$y'-f_ll"ggpqnqg. 1he Clompany shali respond to such requ*sts within a re*sr:nable

period of time, but in no event later than 30 days after receiving hlFA's request. When reque,sted

in writing lly LIPA, the Company's re$prlnse shall be in rvriting. To thc extent thc inlbrmaticn is

kn*wn to or reaso*ably ascertainahle by the Company at the tirne of the request, the Campany's

rsspon$$ shall demonstrate a good thith etfort to provids reasonably accurate and detailed ansrvers

ta nll of EIIA's requests.

(c)-C.gug'H'AnyConfidenti&1BusirressIntbrmation(.,CBI,,)thatthe

Compiiny subrnits ta I-IFA pursuant io paragraph (b) sl:all Lrr: protectcd in accordance with $14 a{'

TSCA and 40 CFR Fart 2.

V. $SQqF.S,$"+",8UAP.II-ITY IJTq}{.T$A $U$f QBDEE

(u) SgWa This section sets forth the procedures by which the Company's rights and obligations

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

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

Company (the 'oSuccessor in Interest"),

(b) B-eje-trprr of Tran$fbr PalF to }{qt

(1) Before NOC. If the transfer frorn the Cornpany tc the Successor in Interest is effective

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

substance from the Company pursuant ta 40 CFR 720.102, the Successor in Interest must subrnit
32

new PMN to EPA and complyfully with ser:tion s(a)(l) af TSCA and 4S CFR part 720 before

comm{Jnuing manufacture nr import of the PMN suhstirnce.

(2) After_h{_O_C. lf the transfer from the Company to the Successor in Interest is effective

after EFA receivr;s a NOC, the Successor in Interest shall comply with t]:re tenns of this Order and

shall not he requirr:d to suhmit a nsw PMN to EPA.

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

{1} '-Successsr in Interest" mffans a persorr outside the Company who has acquired the

Company's full interest in the righLs to rnanufacture the PMN substance, including all orvnership

rights and legal liabilities, through transfer documents signed by the Company, &s transferor, and

the Successor in Interest, as transferee. 'lhe tefin excl.udes psrsons who acquire less than the f'ull

interest of the Company in the FIVIF,I substance, such as a licensee rvho has acquired a lirnited

licensc to the patent or ma"uufacturing rights associated rvith the PMN suhstance. A Suocesscr in

Interest must be incorporated, lic*nsed, or dcing business in the United States in accotdancs with

4t) CIIR 72fr.22{a)(3) and 40 CFR 720.3(z).

(2) -'Transfer Docurnsnt" means the legal instrument(s) used tc conv*y the interests in the

PMN substanse, including the right to rnanufucture the FMN substanceo from the Company to tlte

Successor in Interest.

(d) Notices.

{} ) Notice to Successar i}L lqferest. On or before the eff-e$tive date qrf the transfer, tfie

Company shail provide to the Successor in lnterest, hy registered mail, e sopy of the Consent
33

Orclcr and the "Notice of Trzursfer" docurnentwhich is incorparated by refereilce as Attachment I3

to this Order.

(2) ilqti.qe.to EF1A,- Within 10 business tlays of the effectivo datc of the transfer, thc

Company sha1l, by registcred mail, submit the lully executed Notice of. Tra*-tfur docunrent to:

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

Pemsl'lvania Avenue, N.'\M., Washington,. D"C. 20460.

(l}MCopiesoftheTransferDocumentmustbenraintainedbythe

Successor in Interest at its principal place ofbusirress, and at all sites wher* the PMN substance is

manufactured. Copies of the Transfer Docuruent must atso be made available for inspection

pursuant tu Section 11 of 'ISCA, must state the effcctive date of transfer, ancl must contain

provisions which expressly traasfer liahiiity for the PMN substauce unrler the terms of this Order

from the Co:npany to the Successcr in Interest.

{e) tiability.

(1) The Cornpeny shall be liable for compliance rn'ith thdrequircments of this Orderuntil

the effective date of the transfer clescribed above.

(2) The Successor in Interqst shall be Iiable fcrr complianoe r.vith the requirernent$ of this

Order effective as of the date of transfer.

(3i Nothing in this section shall be construed to proiribit the Agen+y from taking enfurcement

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

made, during the time in which the Cornpany ffianufactured- processed, used, distributed in

cornmercs, CIr disposod of the PMN substance pursuant to the terms of this Consent Order.
14 e 1.ri
-35

vI.,M{}.&IEICATI{}H*{ff J}jffi Yg$#t_s"Ii._Ar-q$*r}Tfi ilHt**"EEm(

(a) Ps:itip-ns.

(1) The Companymay petition EPA at any time, based uporr llo\&'inlbrmation on the

cuvironrnental effsuts or enviraruR*ntal relcasc of the IjMN substance, to rnodify or revoke

subst*ntive provisions of this Order.

{2} The sxposutcs and risks idcntificd by EPA during its revierry ol'the PMN substancc ancl

tho infonnation EIIA d*tennined t+ he necessilry tc er,*luate those cxposures and risks are

described in the preamble to this Ordsr. Itowever, in rlctcrmining wir+:ther to arnencl or revoke this

Order, trPA will co*sider all rclcvant infi:nnation avaiiablc at thc tirnc tlre Agency rnakes thal

detcrnrin*tinn, incluiling, whtlrr: appropriate, any reat;L*jsrirTtent of the test data or otlier infrtr'ir-ratiou

that srrpports the findings in ihis Order, arr cxrrmination of rreu, test data or otfter information or

analysis, and any other reievant information.

(3) EPA rvill issue amodification or.revocation if EPA deteimines that the activities

proposed therein will nst present an unreasonable risk af irrjury to health or the environment and

rvill not result in significant or suhstantial human exposure or substantial environmental release in

the absence of data sufficient to permit a rt:astlned evaluation of ths lrealth ar envirottm.ental

effe*ts af the Ph4bi substance.

(fi fn additian, the Compary may petition F,PA at any tirns to make other mcdifications to

the language of this Order. EPA will issue silsh a modification if EPA det*rmirres that the

modifi+ation is useful, apprapriate, and consistent rvith the structnre and intent of this Order as

issued.
36

ft) Modi{ip+#p,S or Revocation by EP& Based on study results describing in the paragraph {d) of

the Testing Section or if EPA becoms$ aware of infonnation that the terms of the Consent Order

are not being adhered to by downstream users as described in paragraph (d[z) of the Distribution

Section, EPA may modify or revoke this Consent Order by follawing procedures set out in these

paragraphs.
"37

YrI. Esm,eT_$, F*S_qH$EH:H_Q-Ep&Lq

(a) Y[+i.vqr. By *onsenting t* the entry of this Ordt-.r, the Cornpany waivos its rights to file

objections to this Orrier pursuant to scction 5{e}{1}(C) of I'SCA, ta receive service of this Order no

li:ter than 45 days beli:le the end of the revicrv period trrursuant to section 5{e}[1](B) *f TSCA, and

to challenge th.e vatidity of this Order in any subsequ+nt action, Consenting to the cntry of this

Ordcr, and agreeing to be hound hy its terms, rlo nr:t constitute ;ln adlni.ssion by the Cr:rnpany a.s to

the facts or conclusions undcrl.ying the Agency's deteffi:inations in this proceeding. Ihis u'aiver

does not affect auy other rights that the Con:rpany may havc undsr TSCA.

(b) e"BJ-srirgk_qtg* By signing tiris Order. the Courpany represerits that it has careftlly revierved

this dacument and hercby agrs$s that all informatir:n h+rein that is claimed as confidential by the

Cornpanyipersection I4 +f TSCA,40 CFR Part ?20 Subpart E, and 40 CFR Part 2) is correctly

identifred r.+,ithin brackets anrl that any infrirmation that is not brackct*tl is not claimsd as

confrclential. 'l'o make this dacument available {trr puhlic viewing, hlPA will reurave only the

infbrmatiorr cantained lvithin the brackets.

''il+ o " 1r" /-\-

{ f/l ,tr r.;",Y- t3Y:r | --'U/ 4 L t: P' -.**..J-..-dMaria J" Doa, Ult.D. Director

Chemical Control Division

Title:

Otlice of Polluticn Prevention and Toxics

Compa*yl
A'I'TAC}IMENT A

FEITINITIONS

Note: The attached Order mdy not contain sorne *f the terms defined below.

"Chemical name" nre&ns the seientific designation of a chemi*al substance in a+cordaftffe

with the ncmenclaturc system developed hy the Cher:ical Abstracts Seruice's rules nf

nomenctature, or a nfrme which will clearly iclentily a *hemical substance {br the puqpose of

conductiflg a hazard evaluation.

"Compafly" rneafls the person or persons suhject to this Order.

o'Common n&rne" rneans any designation or identili*aticn such a.s code name' code number,

tracle nafile, brand narns? or gonerio chemical name used to identify a chemical substance other

than hy its chemical fl&rne.

t'Containsr" me&ns any bag, barrel, bottleo box, can, cylinder, drum, reaction vessel, storage

tank, or the like that contains a hazardous chemical. F'or purposss of tlris section, pipes or piping

systems, and engines, fueI tanlcs, or other operating systems in a vehicle, are not sonsiderecl to be

contaiuers,

*'Ccntract Manufa$turer" rneans a pers$n, outside the Campany, who is authorized to

r:ranufacturethe PMN substance under the u:rnditions specified in Part fI. of this Consent Order

and in the Consent Order for Contract Manufscturer.

"Identity" means any chemical or oonlmon nfitns used to identify a chemical substan*e or a

mixture containing that substance.

"lmmediats use.'o A ehemical substanfs is far the ooimmetliate use" of a person if it is under

the eontrol o[ and used only by, t]re person w.hc transferred it from a labelecl *ontainer and u,ill

only be used by that psrson within the work shift in which it is transfered fram the labeled

container.

"Manufasture" m$alls t* producs or manufa*ture in tlhe United States or irnpurt into the

custams territory of the United States.

"Manufacturing streamo' means all reas*nably anticipated transfer, flow, or disposal of a

chcrnical substance, regardless of physical state or soncsutration, thr:ough all intsrded operaticns

of manufacture, including the cleaning of equipment.

"MSDS" means rnaterial saiety data sheet, the wr-itten listing nf clata for the chemical

substance-
2

'lion-indnstrial use" means use olher than at n facility whcre chemical substances or

mixtures are manufactured or processed.

'?MN substance" means the chemical substance deecribed in the Prornanufacture notice

submitted by the Company relwant to this Order.

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

substance, regardless ofphysical state or con@nhation, thmugb all intendod operations of

procrxsing, including tha oleaning of equipmcnt.

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

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

approval that prcvents a reasoned evaluation ofthe health or environmentd effects ofthe PMN

substance.

"lscientifically equivocal dara'-'means data which, although developed in apparent

conformity with the Good Laboratory Practice Standards and EPA-approved protoools, aro

inconclusive, intemally inmnsistcnt, or otherwise insufficient to permit a reasoned waluation of

the potential risk of injury to human healt'h or the environmont of the PMN substance.

"sealed containet'' means a closed container that is physically and chemically suitable for

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

nor environmeutal release of, the PMN substance during transport and storagc.

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

mbstance, regardiess ofphysical state or eoncenkalion, thmugtr all intcnded operations of

industrial, commcrcial, or consumer use.

"Waters of the Uniled States" has the meaning set forttr in 40 CFR 122.2.

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

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

'nVorkplace" means an establishment at one geographic location contahing one or more

work areas.
JTTTACHMENT'ts

NOTTCE OF T'RILIrISFER

OF

TOXIC SUBSTANCES CONTROL ACT

SECTION 5(e) CONSENT 0RIIER

C*mpany (Transferor) PMN Number

1 . TreqEfer sf Ma$ufa$rslEi*1s" Effective on

atherwise transf+r to

the Compary did sell or

* (n'Successor in Interest") the rights

and liabilities assaciated with manufacture of the ahove-referenced cheiuical substa*ce, which was

the subject af a prflnanufacture notice f'PMN") and is gaverned by a Consent firder issued by the

U-S. Environmental Protestion Agency {"EPA"} under the authority of $5(e) of the'foxic

Iiubstances Control Act {"TSCA," 15 U.S.C. $2$0a(e}).

2. Assumption cf Liability. The Successor in Interest hereby cefiifies ttrrat, as of the effective date

af transfbr, all actions or omissions governed by the applicable Conscnt Order lirniting

manu{h+ture} processing, use, distribution in commerce and disposal of the PMN substan*e, shall

be the responsihility rrf the Succsssor in Interest. Su$cessor in Interest also certifies that it is

incoqporated, Iicensed, or doing business in the l-lnited States in ascordance with 40 CFR

720.2?{a)(3}.

3. Coq{ide".lili"q}'F-qsJ,.$S-q$*Inf-olsfgligu. Thc Succsssor in Inierest heleby:

"-._.-- reasserts,

_ 

relinquishes, or

*- _ madifies

all Conlidential Business Intbrmation ('lCBf') claims made by the Comp*ny, pursuinlt to Section

14 of TSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishss" is

indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is

indicated, such modification shall be explained in detail irr an attachment to this Notice of

Transfer. Infarmation which has been previously disclosed t* the public (e,g.n a ehemical identity

that was not claimed as CBI by the origina] submitter) would not subsequently be eligihle far

confidential treatment unrler this Notise af Trafisfbr.
fH#p;.l, {r"d;-r-*'}

Signahre *f r\uthcrizecl Sfh*ial

Frinted Name of Auth+rized ffflic,ial

f iiffi f A"th -ri r*d o ffi Ci -t

Successor in Interest

Signature of Authorized Official

Frinted Name of Authariz*d Official

Title of Authorized Of{icia1

Address

T'#XIC $UBSTANCES CT}NTROT, ACT

SECTIfIIS 5(*) CSI{SHI{T f}RDER

}{OT'ICU OF TKAffSFER

{*rntinu*d}

PMN Nurnber

Date

Date

City, State, Zip Code
TOXIC S UB$TAI{CES €ONTROL ACT

SEC'IION 5{e) CONSENT ORDER

NOTICE OF.'TRANSFER

{continued}

Sucrcss*r's T*chni*al Contnct

Address

Phone

{^on"ffit#'ffiffi \ ,TS.r', l'*rt n .'

:!Yt +