TSCN T{ON.C I}NFIDENTIAT BUSINESS INFIIRMATI(}N

DOCUMENT CONTHOL NUMBEH DATE RECEIVED

DOCUMENT DESCHIPTION

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LTNITED S TATES ENVIRONMENTAL PROTECTION AGENCY

OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF A NEW CHEMICAL SUBSTANCES

PENDING DEVELOPMENT OF INFORMATION

In the matter of: Premanufasturg Notice Number:

Huntsman Corporation P-12-l I5 and#-12-l l6

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Consent Order, Consent Order for Contract Manufacturer, and Determinations Supporting

Consent Order

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TABLE OF CONTENTS

Prp+ruhle

I. Introduction

II. Summary of Terms of the Order

Iil. Contents of PMN

ry. EPA's Assessment of Risk

V. EPA's Conclusions of Law

VL lnformation Required to Evaluate Environmental Effects

C_onsent Ordel

I. Scope of Applicability and Exemptions

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

Submission and Evaluation of Information

IlL Recordkeeping

IV. Successor Liability Upon Transfer of Consent Order

V. Modification and Revocation of Consent Order

VI. Effect of Consent Order

Attachment A - Definitions

Attachment B - NoticE of Transfdr of Consent Order

Attachment C * Consent Order for Contract Manufacturer
r-riPREAMBLE

r. IHHEOD.UCTTpI{,

Under the authority of g 5(e) of the Toxis Substances Control Act ("TSCA") (15 U.S'C.

260a(e)), the Environrhental Protection Agency ("EPA" or "the Agency") issues the attached

Order, regarding premanufacture notices ("PMN") P-l2-ll5 and P-12-l16 for the chemisal

substancess

(**the PMN substances") subrnitted by

Huntsman Corporation ("the Company"), to take effsct upon expiration of the PMN review period'

The Company submitted these PMNs to EPA pursuant to $ 5(a)(1) of TSCA and 40 CFR Part 720.

Under $ I 5 of TSCA, it is unlawful for any person to fail or refuse to comply with any

:,

provision of $ 5 or any order issued under $ 5. Violators rnay be subject to various penalties and to

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

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

these two, are subject to the $ l2(b) export notice requirement.
iv

rr. $IJMMA,B_YJ}F.rERMS pE THE oBpEB

The Consent Order for these PMN substances requires the Company to:

(a) label these PMN substances and provide Material Safety Data Sheets ("MSDS") and worker

training in accordance with the provisions of the Hazard Communication Program section;

(b) not use PMN substances P-12-115 other than as a chemical intermediate to prepare an

interfacial tension reducer for enhanced oil and P- tZ-Ll6 other than as an interfacial tension

reducer for enhanced oil recovery;

(c) distribute these PMN substances only to a person who agrees to follow the sarne restrictions

and to not further distribute these PMN substances until they have been partitioned into oil or

petroleum streams fbllowing use as an interfasial tension reducer for for

enhanced oil recovery applications;

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

(e) maintain sertain records.

(fl A Consent Order for Contract Manuthcturer is attached to extend these requirements to any

Contract Manufacturers.
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By signing this Order, the Cornpany represents that it has carefully reviewed this document and

agrees that all information herein that is claimed as conf,rdential by the Company 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

ehemical identity, production volurne, and manufacturing information

CheJ{'l.ie+l ldentity:

P-12-1 l5

P-12-1 16

Generic:

P- 12- l I 5 Alkylbenzene sulfonic acid

P-12-1 16 Alkylbenzene sulfonate sodium salt

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p- l2- l l5 Chemical intsrmediate to prepare an interfacial tension reducer for enhanced oil

recovery.

P-12-116 Interfacial tension reducer for enhanced oil recovery.

IpsX,Pata Sub_mitted with the-.PMN: Ecotoxicity acute base set on P-12-l l6

information contained within the bracketsllilenti*l Busin+sx l*ftr'nin,+n:,[]lttll .fl
VI

IV. ,SPA1$- A$$_

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

releases of these PMN substances, hased on the information currently available to the Agency.

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Based on test data on the P-12-0116, EPA identified the following concentrations of concern:

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

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

EPA has applied the results of the test data to P-n-Al15, as an analogous chemical substances.

Absorption is poor from the skin, moderate from the CI tract, and good from the lung (analog).

Concern for surfactant effects on the lung; corrosion to eye, mucous membranes and lung based on

surfactant properties of the sompounds and analogues. Rabbit dermal study indicated potential for

skin irritation.

Environryeptal Release Summarv:

During the initial review of the PMN that applied generic engineering scenarios published by EPA

relevant to the notified use, EPA assessed the following releases and exposures of the PMN

substances.
vI1

Processing/Use

Pl2-l t5 P12-116

Workers

(#lsite)

Exposure

(days/year)

Dermal Exposure

(mg/day)

Inhalation Exposure

(mg/day)

Releases

(days/year)

Release to Water

(kg/day)

Surface Water

Concentration (ppb)

Days Exceeding

Concern Level

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

release of the PMN substances, or any waste stream from manufacturing, processing, and use

containing the PMN substances, into the waters of the lJnited States that would result in surface

water concentrations exceeding 4 parts per billion ("ppb"), when calculated using the rnethods
{? 1 1 1

described in 40 CFR 721.91, Except for quantities of the PMN substances that have partitioned

into oil or petrolsum streams following use as an interfacial tension reducer for enhanced oil

recovery applications, the Company shall distribute the PMN substancs outside the Company only

to a person who has agreed in writing prior to the date of distribution, to, among other

requirements, to also abide by this water release trigger and shall maintain such agreements on file

for inspection by the Agency.

y, EPA'S 9QNCLUSIONS Or tAW

- The following findings constitute the basis of the Consent Order:

(a) EPA is unable to determine the potential for ecological toxicity and environmental fate from

environmental release of the PMN substances, EPA therefore concludes, pursuant to $

s(eXlXAXi) of TSCA, that the information available to the Agency is insufficientto permit a

reasoned evaluation of the environmental effects of the PMN substances,

(b) In light of the potential risk of ecological toxicity posed by the unsontrolled manufacture

(including import), processing, distribution in commerce, use, and disposal of the PMN substances,

EPA has concluded, pursuant to $ 5(e)(lXAXii)(I) of TSCA, that uncontrolled manufacture

(including import), processing, distribution in conlmerce, use, and disposal of the PMN substances

may present an unreasonable risk of injury to the environment.
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Pended Testlnq. The following additional information would he required to evaluate the

following effects which may be caused by the PMN substances.

Aquatic invertebrate chronic toxicity test, freshwater daphnids

(OPPTS 850.1300); and

Fish chronic toxicity in clean dilution water (OPPTS 850.1400).

The Order does [ot require submission of the above pended testing at any specified time or

production volume. However, the Orderos restrictions on manufacture, processing, distribution in

commerce, and use of the PMN substances will remain in effect until the Order is modified or

revoked by EPA based on submission of that or other relevant information.
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s #h '*, -.ffiJ UNITED STATE$ ENVIRONII,IHHTAL PROTECTIOH AGEHCY

WA$HINGTON, D.C, 20460

OFFICE OF CHEMICAL SAFETY

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CONSEF{T ORDER

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

distribution in commercs, use and disposal of these chemical substan*rffi*nzenesulfonic acid,

-

dimethyl-, mono-Cl l-16-sec-alkyl derivs.l Y-12-1 l5 and

P12-1 16 ("the PMN substances") in the United States by

the Huntsman Corporation{"the Company"), except to the extent that those activities are exempted

by paragraph (b).

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

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

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

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

the following exemptions, and (2) such complianse is documented by appropriate recordkeeping as

required in the Recordkeeping section of this Order.

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( I ) Export. Until the Company begins commercial manufacture of the PMN substances

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

or distribution in commerce of the PMN substances salely for export in accordance with TSCA

$$12(a) and 12(b),40 CFR 720.3(s) and 40 CFR Part 7A7. However, oncs the Company begins to

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

involving the PMN substances are exempt as'rsolely for export" evefi if some amount of the PMN

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

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

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

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

Testing section of this Order.

{2) Research & Development (ooR&D"), The requirements of this Order do not apply to

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

small quantities solely for research and development in accordance with TSCA $5(hX3), 40 CFR

720,3(cc), and 40 CFR 72fi.36, The requirements of this Order also do not apply to

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

when manufactured solely for non-commercial research and development per TSCA $5(i) and 40

cFR 720,30(i).

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

they are produced, without separate comrnercial intent, only as a "byproduct" as defined at 40 CFR

720.3(d) and in compliance with 40 CFR 720.30(9).
3

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

PMN substances when they ars rnanufactured, 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 part,

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

when they are imported as part of an "article" as defined at 40 CFR 720,3(c) and in compliance

with 40 CFR 72fr,22{bxl).

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

substances that have partitioned into oil or petroleum streams following use as an interfacial

tension reducer for enhanced oil recovery applications.

(c) Aulomatic Sunset, If the Company has obtained for the PMN substances a Test Market

Hxemption ("TME") under TSCA $s(hxl) and 40 CFR 72A38 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, any such exemption is automatically rendered null and void as

of the effective date of this Consent Order.
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0.H'TNFORMATION

P,BSHIEITIP}{

l'he Company is prohibited from manufacturing (including importing), processing,

distributing in commerce, using, or disposing of these PMN substances in the United States, for

any nonexempt commercial purpose, pending the development of information necsssary for a

reasoned evaluation of the environmental effects of ttre substances, and the completion of EPA's

review r:f, and regulatory action based on, that information, except in accordance with the

conditions described in this Order.

HAUARD C0MMUTICATIOIT{ TBQGRAM

(a) Written H-A-zflrd eommunication Program, The Company shall develop and implement a

written hazard communication program for these PMN substances in each workplace. The written

program will, at a minimum, dessribe how the requirements of this section for labels, MSDSs, and

other forms of warning material will be satisfied. The Company must make the written hazard

comrnunication program available, upon request, to all employees, contractor employees, and their

designated representatives. The Company may rely on an existing hazard communication

program, including an existing program established under the OSHA Hazard Communication

Standard (29 CFR 1910.1200), to cornply with this paragraph provided that the existing hazard
5r

communication program satisfies the requirements of this section. The written program shall

include the following:

(l) A list of chernical substances known to be present in the work area which are subject to

a T$CA section 5(e) consent order signed by the Company or to a TSCA sestion 5(a)(2) SNUR at

40 CFR Part T2I,subpart H, The list must be maintained in each work area where these PMN

substances are known to be present and must use the identity provided on the MSDS for the

substances required u:der paragraph (c) of this section. The list may be compiled for the

workplace or for individual work areas, If the Company is required either by another Order issued

under section 5(e) of TSCA, or by a TSCA section 5(aX2) SNUR at 40 CFR Part 721, subpart E,

to maintain a list of substances, the lists shall be combined with the list under this subparagraph,

(Z) The methods the Company will use to inform employees of the hazards of non-routine

tasks involving these PMN substances (e.g., cleaning of reactor vessels), and the hazards

associated with these PMN substances sontained in unlabeled pipes in their work area.

(3) The methods the Company will use to inform contractors of the presense of these PMN

substances in the Company's workplaie and of the provisions of this Order if employees of the

contractor work in the Company's workplace and are reasonahly likely to be exposed to these

PMN substances while in the Company's workplace.

(b) Labelins.

(1) The Company shall ensure that each container of the substances in the workplace is

labeled in accordance with this subparagraph (bxl).

(i) The label shall, at a minirnum, contain the following information:
A* v

(A) A statement of the health hazards(s) and precautionary msasure(s), if

&try, identified either in paragraph (0 of this section or by the Compzuiy, for the PMN substances.

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

recognized.

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

measure(s), if nily, identified either in paragraph (f) of this section, or by the Company, for the

PMN substances,

(D) A statement of exposure and precautionary measure(s), if ffiy,

identified either in paragraph (f) of this section, or by the CompanY, for the PMN substances.

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

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

prosess containers, as long as the alternative method identifies the containers to which it is

applicable and conveys information specified by subparagraph (bXlXi) of this section, Any

written materials must be readily aecessible to the employees in their work areas throughout each

work shift.

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

substances ars transferred from labeled containers, and which are intended only for the immediate

use of the employee who performs the transfer.

(iv) The Company shall not remove or deface an existing label on containers of

these PMN substances obtained from persons outside the Company unless the sontainer is

immediately re-labeled with the inforrnation specified in subparagraph (bxl)(i) of this section.
(2) The Company shall ensure that each container of the substances leaving its workplacefor distribution in commerce is labeled in aecordance with this subparagraph (bX2).

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

(A) The information prescribed in subparagraph (bX1)(i) of this section.

(B) The name and address of the manufacturer or aresponsible pafiy who

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

emergency procsdures.

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

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

Department of Transportation,

(3) The label, or alternative forms of warning, shall be legible and prominently displayed'

(4) The label, oralternative forms of warning, shall U* prinied in English; however, the

information may be repeated in other languages'

(5) If the tabel or alternative form of warning is to be applied to a mixture containing these

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

sestion 5(e) Order applicable to the Company, or subjectto a TSCA section 5(aX2) SNUR at4A

CFR Part T2l,subpart E, or defined as a "hazardous chemical" under the OSHA Hazard

Communication Stanclard (29 CFR 1900.1200), the Company may prescribe onthe label, MSDS,

or alternative form of warning, the measures to control worksr exposure or environmental re lease

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

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

sesk a determination of equivalency for such alternative control measurss pursuant to 40 CFR

721.30 before prescribing them under this subparagraph (bxs).

(6) If the Company becomes aware of any significant new information regarding the

hazards of the PMN substances orways to protect against the hazards, this new information must

be added to the label within 3 months from the time the Company becomes awafe of the new

information. If the PMN substances are not being manufactured, processed, or used in the

Company's workplace, the Company rnust add the new information to the label before the PMN

substances are reintroduced into the workplace.

(c) Material Safety Data Sheets.

(l) The Company must obtain or develop an MSDS for these PMN substances.

(2) The MSDS shall contain, at a rninimum, the following information:

(i) The identity used on the container label of these PMN substances under this

section, and, if not claimed confidential, the chemical and common names of the PMN substances.

If the chemical and common names are claimed confidential, generic chemical namss must be

used,

(ii) Physical and chemical characteristics of the substances known to the Company,

(e.9., vapor prsssure, flash point).

(iii) The physical hazards of the substances known to the Company, including the

potential for fire, explosion, and reactivity,

(iy) The potential human and environmental hazards as specified in paragraph (f)

of this section"
;9

(v) Signs and symptoms of exposure, and any medical conditions which are

expected to be aggravated by exposure to the PMll substances known to the Company.

(vi) The primary route s of exposure to the PMN substances.

(vii) Precautionary msasures to control worker exposure and/or environmental

release required by this Order, or alternative control measures which EPA has deterrnined under 40

CFR 721.30 provide substantially the same degree of protection as the identified control measures.

(viii) Any generally applicable precautions for safe handling and use of the PMN

substances which are known to the Company, including appropriate hygienic practices, protective

measures during repair and maintenance o'f contaminated equipment, and procedures for response

to spills and leaks.

(ix) Any generally applicable sontrol measures which are known to the Company,

such as appropriate engineering controls, work practices, or personal protective equipment,

(x) Emergency first aid procedures known to the Company.

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

(xii) The name, address, and telephone number of the Company or another

responsible party who aan provide additional information on the chemical substances and any

appropriate emergency procedures,

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

Company must mark the MSDS to indicate that no applicable information was found.

(4) Where multiple mixtures containing these PMN substances have similar compositions

(i,e,, tiie chemical ingredients are essentially the same, but the specific composition varies from
10

mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of

these multiple nrixtures.

(5) If the Cornpany becomes aware of any significant new information regarding the

hazards of these PMN substances or ways to protect against the hazards, this new information must

be added to the MSDS within 3 months from the time the Company becomes aware of the nsw

information. If these PMN substanees are not being manufactured, processed, or used in the

Company's workplace, the Company must add the new information to the MSDS before these

PMN substances are reintroduced into the workplace.

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

Company are providecl an appropriate MSDS with their initial shipment and with the first shipment

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

containers or send it to the person prior to or at the time of shiprnent.

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

that it is readily accessible during each work shift to employess when they are in their work areas.

(S) The MSDS may be kept in any form, including as operating procedures, and may be

designed to cover groups of substances in a work ar$a where it may be more appropriate to address

the potential hazards of a process rather than individual substances. However, in all cases, the

required information must be provided for the PMN substances and must be readily accessible

during each work shift to employees when they are in their work areas.

(9) The MSDS must be printed in English; however, the information may be repeated in

other languages.
1t

The Company must ensure that employees are provided

with information and training on these PMN substances. This information and training must be

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

substances and whenever the PMN substancss are introduced into the employee's work area for

the first time.

(1) The information provided to ernployees under this paragraph shall include:

(i) The requirements of this section.

(ii) Any operations in the work area where the PMN substances are present.

(iii) The location and availability of the written hazard communication program

required under paragraph (a) of this section, including the list of substances required by

subparagraph (aXl) of this section and MSDSs required by paragraph (c) of this section.

(2) The training provided to employees shall include:

(i) Methods and observations that may be used to detect the presence or release of

the substances in or from an employee's work area (such as exposurs monitoring condusted by the

Company, continuous monitoring devices, visual appearance, or odor of the substances when

being released),

(ii) The potcntial human health and environmental hazards of these PMI-I

substances as specified in paragraph (f) of this section.

(iii) The measures employecs can take to protect themselves and the environrnent

from the substances, including specific procedures the Company has implernented to protect

employees and the environment from exposure to these PMN substances, including appropriate

work pra+tices, emergency procedures, psrsonal protective equipment, engineering controls, aud
t2

other measures to control worker exposure and/or environmental release required under this Order,

or alternative control measures which EPA has determined under 40 CFR 7T 3A provide the same

degree of protection as the specified control measures,

(i.v) The requirements of the hazard cornmunication program developed by the

Company underthis section, including an explanation of the labeling systern and the MSDS

required by this section and guidance on obtaining and using appropriate hazard information.

(e) De Mir-rir-nis egr-rcentrations, The requirements of this Hazard Communication section do not

apply to quantities of the PMN substances that are (l) present in the work area only as a mixture

and (2) at a concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or

volume if the PMN substances is identified as apotential carcinogen in paragraph {0 of the Hazard

Cornmunication Program section of this Order). This exemption is not available if the Company

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

reconcentrated above the 1.0 or 0. I percent level, whichever applies. If this Order contains New

Chemical Exposure Limits provisions or Release to S/ater provisions that, respectively, specify a

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

concentration specified here, then this de minimis exemption does not apply to those provisions,

following human health and environmental hazard and precautionary statements shall appear on

each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) of this section:

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13

(1) Environmental hazard statements. These substances may be:

(i) toxis to fish.

(ii) toxic to aquatic organisms.

(2) Environmental hazard precautionary statements. Irlotice to users:

(i) disposal restrictions apply,

(3) Human health hazard statements. This substance may cause:

(i) skin irritation.

(ii) serious eye damage

(4) Hurnan hazard precautionary statements, When using this substance:

(i) avoid skin contact.

(ii) avoid breathing the substance,

(iii) avoid ingestion.

(iv) use skin protection,

(5) The human health, environmental hazard aild precautionary statement on the label

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

MSDS for details."

\{aNIj{,4'cTURING

(a) P.r.ohibition. The Company shall not cause, encourage, or suggest the manufacture of these

PMN substances by any other person outside the company, except a Contract Manufacturer as

described in paragraph (b),
14

(b) Notwithstanding paragraph (a), the Company may cause a "Contract Manufacture" outside the

Company to manufacture the PMN substance according to the following conditions:

( 1) The Contract Manufacture must be under contract to the Company to manufacture the

PMN substances solely for the Company. The Contract must specify the identity of the PMN

substances, the total quantities to be manufactured, and the basic technology to be use for

manufacturing.

(2) The Company shall obtain from each Contract Manufacturer a signed Copy of the

Consent Order for Contract Manufacturer (attached to this Order as Attachment 0 and subrnit the

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

Contract Manufacturer. The Contract Manufacturer of Company must receive a fully executed

copy of the Consent Order for Contract Manufasturer from EPA before the Contract Manufacturer

may begin manufacture.

(3) If at any time, the company learns that the Contract Manufacturer has failed to comply

with any of the conditions specified in the Consent Order for Contract Manufacturer, the Company

shall immediately cease to cause the Contract Manufacturer to manufacture the PMN substances,

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

unless the Company is able to document each of the following:

(i) That the Company has, within 5 working days, notified the Contract

Manufacturer in writing that the Contract Manufacturer has failed to comply with any of the

conditions specified in the Consent Order for Contract Manufasturer.
(ii) That, within 15 working days of notifying the Contract Manufacturer of the

noncompliance, the Company received from the Contract Manufacture, in writitrg, fl statement of

assurance that the Contrast Manufacturer is aware of the terms of the Consent Order for Contract

Manufacturer and will comply with those terms.

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

under subphragraph (ii) of this section, the company has notice or knowledge that the Contract

Manufacture has failed to comply with any of the conditions specified in the Consent Order for

the Contract Manufacturer, the Company shall imrnediately cease to cause the Contract

Manufacturer to manufacture the PMN substances, shall notify EPA of the failure to comply, and

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

written notification from the Agency.

(cX1) Paragraph (a) shall expire 75 days after promulgation of a final significant new use rule

("SNUR") governing the substances under section 5(aX2) of TSCA unless the Company is notified

on or before that day of an action in a Federal Court seeking judicial review of the SNUR. If the

Company is so notified, paragraph (a) shall not expire until EPA notifies the Company in writing

that all Federal Court actions involving the SNUR have been resolved and the validity of the

SNUR affirrned.

{2) When EPA promulgates a final SNUR for these PMN substances and paragraph (a)

expires in accordance with subparagraph (cXl), the Company shall notify each person whom it

causes, eilcourages or suggests to manufacture the PMN substances of the existence of the SNUR,
t6

(3) Faragraph (c)(1) strall not negate the effect of any fully executed Consent Order for

Contract Manufacturer entered into under paragraph (bxz).

(d) The Company shall not manufacture P-12-115 other than as a chemical intermediate to prepare

an interfacial tension reducer for enhanced oil recovery and P-12-116 other than as interfacial

tension reducers for enhanced oil recovery.

TBQCE$SING

(a) The Company shall not process P- 12-115 other than as a shemical intermediate to preparts an

interfacial tension reduser for enhanced oil recovery and P-12-l l6 other than as interfacial tension

reducers for enhansed oil recovery

USE

(a) The Company shall not use P-12-115 otherthan as a chemical intermediate to prepare an

interfacial tension reducer for enhanced oil recovery and P-12-l l6 other than as interfacial tension

reducers for enhanced oil recovery.

DISTBTEUTION

(a) Export Notice Beguitement, No later than the date of distribution, the Company shall notify in

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

Consent Order under section 5(e) of TSCA, these PMN suhstances are subject to the export

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

shall contain, in the form in which it appears in this Consent Order, the following information: (1)
17

the PMN numbers, ffid (2) either (A) the specific chemical identity of the PMN substances, or (B)

if the specific chemieal identity is confidential, the generic chemical identity,

(b) Distribution Requirementq. (i) Except for quantities of the PMN substances that have

partitioned into oil or petroleum streams following use as an interfacial tension reducer for

enhanced oil recovery apptications or as provided in paragraph (c), the Company shall distribute

the PMN substances outside the Company only to a person who has agreed in writing prior to the

date of distribution, to:

(l) I.{otify in writing any personto whom it distributes these PMN substances that, due to

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

to the export notification requirements of TSCA section 12(b) and 40 CFR Part 707 Subpart D,

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

information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN

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

(2) Not further distribute the PMN substances to any other psrson, other than for disposal,

except fbr quantities of the PMN substances that have partitioned into oil or petroleum streams

following use as an interfacial tension reducer for enhanced oil recovery applications.

(3) Comply with the samc requirements and restrictions, if Bny, required of the Company

in the Hazard Communication Program section of this Order.

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

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

(5) Not use PMN P-12-l t5 other than as a chemical intermediate to prepare an interfacial
iB

tension reducer for enhanced oil and P-12-l l6 other than as interfacial tension reducers for

enhanced oil recovery;

(c) Temporarv Transport and $torage. Notwithstanding paragraph (b), the Company may

\/#

distribute the PMN substances outside the Company for temporary transport and storage in "sealed

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

cars or other delivery vehicles with attached tanks) provided the following three conditions are

met:

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

these PMN substances may he distributed only to the Company or a person who has given the

Company 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 ar$ in the possession and control of the Company or a person who has given the

Company the written agreement required by paragraph (b).

(3) The sealed containers must be labeled in accordance withparagraph (bxz) of the

Hazard Communication Program section of this Order'

(d) Recipient Non-Compliaqce.

(l) If, at any time after commencing distribution in comrnerce of these PMN substances, the

Company obtains knowledge that a recipient or transporter of the substances has failed to comply

with any of the conditions specified in paragraph (b) of this Distribution section or, after
I

19

subparagraph (bXZ) expires in accordance with subparagraph (eXI), has engaged in a significant

new use of the PMN substances (as defined in 40 CFR Part 721, Subpart E) without submitting a

significant new use notice to EPA, the Company shall cease supplying the substances to that

recipient, unless the Company is able to document each of the following:

(a) That the Company has, within 5 working days, notified the recipient in writing that the

recipient has failed to compty with any of the conditions specified in paragraph (b) of this

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

submitting significant new use notices to EPA,

(b) That, within l5 working days of notifying the recipient of the noncompliance, the

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

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

or is aware of the terms of the significant new use rules for the PMN suhstances and will not

engage in significant new uses without subrnitting significant new use notices to EPA.

(c) If, after receiving a staternent of assurance from a recipient under subparagraph

(dX1Xb) of this Distribution section, the Company obtains knowledge that the'recipient has failed

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

engaged in a significant new uses of these PMN substances without submitting a significant new

use notice to EPA, the Company shall csase supplying these PMN suhstances to that recipient,

shall notify EPA of the failure to comply, and shall resume supplying the PMN substances to that

recipient only upon written notification from the Agency.

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

substances, EPA obtains knowledge (such as through a TSCA Section l1 inspection or subpoena),
20

that a recipient of the substances has failed to comply with any of the conditions specified in

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

subparagraph (eXl), has engaged in a significant new use of the PMN substances (as defined in 40

CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, EPA may notify

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

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

health or the environrnent. EPA's notice may specify that the Company undertake certain actions

conceming further testing, rnanufacture, processing, distribution, use and/or disposal of the PMN

substances to mitigate Bxposures to better charasterize the risks presented by the PMN substances.

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

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

(a) within 2 weeks from receipt of the EPA notice, the Company complies with such requirernents

as the notice specifies; or

(b) within 4 weeks from receipt of the EPA notice, the Company submits to EPA a written

report refuting EPA's finding and/or the appropriateness of any additional actions imposed hy

EPA. The EPA will respond to the Company, in writing, within 4 weeks of receiving the

Company's report. Within 2 weeks of receipt of EPA's written response, the Company shall

comply with any requirements imposed by EPA's notice or revised response or, cease all

manufacture, processing, distribution, use and disposal of the PMN substances'
21

(e) Sunset Fqllowing SNUR. (l) Subparagraphs (bX2) and (d)(2) of this Distribution section

shall expire 75 days after promulgation of a final SNURs for these PMN substances under section

5(aX2) of TSCA, unless the Company is notified on or before that day of an action in a Federal

Court seeking judicial ,*ui** of the SNUR. If the Company is so notified, subparagraph (bX2)

and (d)(2) of this Distribution section shall not expire until EPA notifies the Company in writing

that all Federal Court actions involving the SNUR have been resolved and the validity of the

SNUR affirmed.

(2) When EPA promulgates a final SNUR for these PMN substances and subparagraphs (bxz)

and (d)(2) of this Distribution section expires in accordance with subparagraph (eX I ), the

Company shall notify each personto whom it distributes the PMN substances of the existence of

the SNURs, Such notification must be in writing and must specifically include all limitations

contained in the SNURs which are defined as significant new uses, and which would invoke ;

significant new use notification to EPA for the PMN substances. Such notice must also reference

the publication of the SNURs for this PMN substances in either the fgdpfal Rpgister or the Code

of Federal Regulations. After promulgation of SNURs and expiration of subparagraphs (bX2) and

(dX2), such notices may substitute for the written agreements required in the introductory clause of

paragraph (b); so that, if the Company provides such notices to the persons to whom it distributes

the PMN substances, then the Company is not required to obtain from such persons the written

agreements specifiecl in paragraph (b).
22

HFLEAS, p_ rO MAIER

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

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

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

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

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

number of kilograms/day/site released

x 1000 : N parts per billion

receiving stream flow (million liters/day)

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

72l,gl. However, 40 CFR 72l.gl (aXa) does not apply. Instead, if the waste stream containing

the pMN substances will be treated using biological treatment (activated sludge or equivalent) plus

clarification, then the amount of PMN substances rsasonably likely to be removed from the waste

stream by such treailnent may be subtracted in calculating the number of kilograms released. No

more than 90 percent removal efficiency may be attributed to such treatment.

.(b) In lieu of calculating the quotient in subparagraph (lXa), monitoring or alternative calculations

may be used to predict the surface water concentration expected to result from the intended release

of the substances, if the monitoring procedurss or calculations have been approved for such

purpose by EPA. EPA will review and act on a written request to approve monitoring procedures

or alternative calculations within 90 days after such a request is received. The Agency will inform

the Company of the disposition of such requests in writing and, where a request is denied, will

explain the reasons therefore.
23

Iil. RECORDKEEPTNG

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

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

section ll of TSCA:

(1) Exemptions. Records documenting that the PMN substances did in fact qualiff for any

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

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

exemption being clairned by the Company. Any amounts or batches of the PMN substances

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

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

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

sections l2(aXlXB) and l2(b), respectively. Any amounts or batches of the PMN substances

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

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

5 years from the date of their creation, the records required by 40 CFR 720.78{b), For any

amounts or batches of the PMN substances claimed to be eligible for any other exernption

described in Sestion I, Paragraph (b) of this Order, the Company shall keep records demonstrating

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

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

(2) Records documenting the manufacture volume of the PMN substances and the

corresponding dates of manufacture ;
24

(3) Records docurnenting the names and addresse$ (including shipment destination

address, if different) of all persons outside thc site of manufhcture to whom the Cornpany directly

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

substances sold or transferred on such date;

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

(5) Records documenting establishment and implementation of the hazard communication

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

(6) Copies of labels required under the Hazard Communication Program section of this

Order;

(7) Copies of Material Safety Data Sheets required by the Hazard Communication

Program section of this Order;

(B) Records documenting cornpliance with any applicable manufacturing, processing, use,

and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections of

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

Order;

(g) Records documenting compliance with any applicable disposal requirements under the

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

disposal, ffid volume of PMN substances disposed. Where the estirnated disposal volume is not

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

maintain other records which demonstrate establishment and irnplementation of a program that

ensures cornpliance with any applisable disposal requirements;
Z5

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

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

Order;

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

section of this Order, if applicable; and,

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

substances are manufactured.

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

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

Company's customers.

(c) OIIB Control Number. Under the Papet'work Reduction Act and its regulations at 5 CFR Part

1320, particularly 5 CFR 1320,5(b), the Company is not required to respond to this u'collestion of

infbrmation" unless this Order displays a currently valid control number from the Oflice of

Management and Budget (I'OMB"), and EPA so informs the Company. The o'collection of

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

OMB Control Number 2070-0012.

rv.REouEsrs FoR pRE-rrysppQrloN rNroRMArIgll{

(a) EPA's Request for InforFation. Pursuant to section l1 of TSCA and 40 CFR 720,122, EPA

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

associated with these PMN substances. To facilitate such inspections, EPA personnel may contact
26

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

inspections, Such requests may be written or ora[, The types ol.information that EPA may request

include, but are not limited to, the following:

(l) Expected dates and times when the PMN substances will be in production within the

subsequent t2 months;

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

these PMN substances and may reasonably be exposed to these PMN substances;

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

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

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

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

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

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

conducting an inspection for that purpose,

(b) Comnanyls Resegnse. The Cornpany shall respond to such requests within a reasonable

period of time, but in no event later than 30 days afterreceiving EPA's request, When requested

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

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

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

to all of EPA's requests.
?.1

(c) eonfidpn-tial SlrsinEss,ln-fqffn,afi,on. Any Conficlential Business Inforrnation ("CBI") that the

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with $ t 4 of

TSCA and 40 CFR Part 2.

v. $*ullcEs$pR I,IAEII/ITy UJ|()..JITRSN,$.T,SR OF cQryspNr ()RDER

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

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

substances, including the right to manufacture the PMN substances, to another psrson outside the

Company (the "Successor in Interest").

{b) Relalion of Transfer Date to Notice of Commencement ("NOC").

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

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

from the Company pursuant to 40 CFR 720.1fi2,the Successor in Interest must submit new PMN

to EPA and comply fullywith Section s(aXl) of TSCA and40 CFRpart 720 before commencing

manufacture of the PMN substances.

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

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

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

(c) Definitions. The following definitions apply to this Successor Liability section of the Order:
/_.5

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

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

rights and legal liabilities, through transfer documents signed by the ComPmI, as transferor, and

the Suceessor in Interest, as transferee. The term excludes persons w&o acquire less than the full

interest of the Cornpany in the PMN substances, such as a licensee who has acquired a limited

license to the patent or rnanufacturing rights associated with the PMN substances. A Successor in

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

40 CFR 720,22{aX3) and 40 CFR 72A3{z).

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

PMhl substances, including the right to manufacture the PMN substances, from the Company to

the Successor in Interest.

(d) Notic-e*

(1) NgtiQe to Successor in In{erest. On or before the effective date of the transferr the

Company 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 B

to this Order.

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

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

U.S. Environmental Protestion Agency, New Chemisals Management Branch (7405), 1200

Pennsylvania Avenue, N.W., Washington, D.C' 20460.
29

(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. Copies of the Transfer Document must also be made available for inspection

pursuant to Section l1 of TSCA, 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 Company to the Successor in Interest.

(e) I-iabilitv.

(l) The Company shall be liable for cornpliance with the requirements of this Order until

the effective date of the transfer described above.

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

Order effective as of the date of transfer.

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

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

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

in commerce, or disposed of the PMN substances pursuantto the terms of this Consent Order.

vr. n{qpl Fr c*,:LpJ:Ls*HH"Rp yoc4TroN aH Q,onr $ENT o RpE&

(a) Petitions.

(1) The Company may petition EPA at any time, based upon new information on the

envirorunental effects or environmental release of the PMN substances, to modify or revoke

substantive provisions of this Order.
30

(2) The exposures and risks identified by EPA during its review of the PMN substances

and the information EPA determined to be necessary to evaluate those exposures and risks are

described in the prearnble to this Order, However, in determining whether to arnend or revoke this

Order, EPA will consider all relevant information available at the time the Agency makes that

determination, including, where appropriate, any reassessment of the test data or other information

that supports the findings in this Order, an examination of new test data or other information or

analysis, and any other relevant information,

(3) EPA will issue a modification or revocation if EPA determines that the activities

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

will not result in significant or substantial human exposure or substantial environmental release in

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

effects of the PMN substances.

(4) In addition, the Company may petition EPA at any time to make other modifications to

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

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

issued.

(b) Modifiqali.o"n or Revocation by EPA. Based on study results describing in the paragraph (d) of

the Testing Section or if EPA becomes aware of information that the terms of the Consent Order

are not being adhered to by downstream users as described in paragryh (dX2) of the Distribution

Section, EPA may modify or revoke this Consent Order b; fiollowing procedures set out in these

paragraphs.
31

VII. EFFECT OF CONSENT ORI}ER

(a) Waiver. By consenting to the entry of this Order, the Company waives its rights to file

objections to this Order pursuant to section 5(eXlXC) of TSCA, to reeeive service of this Order no

later than 45 days before the end of the review period pursuant to section S(eXIXB) of TSCA, ffid

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

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

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

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

(b) CFI F":gp,kplS, By signing this Order, the Company represents that it has carefully reviewed

this document and herehy agrees that all information herein that is clairned as confidential by the

Company (per section 14 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Pafi 2) is correctly

identified within brackets and that any infbrmation 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.

Maria J. Doa, Fll'[il., Director

Chemical C*ntr#I Division

Office of Pollution Prevention and Toxics

Nam'J: 'ffi+"af $ N,Wto Title *#raso*

Companyr: ll*r4 {_{.r,a*t #.*p
ATTACHMENT A

DEFINITIONS

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

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

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

nomenclature, or a name which will clearly identiff a chemical substances for the purpose of

conducting a hazard evaluation.

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

"Common name" rneans any designation or identification such as code narne, code number,

trade name, brand nafile, or generic chemical name used to identify a chemisal substances other

than by its chemical name,

o'Container" meftns any b*g, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage

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

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

containers.

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

manufacture the PMN substances underthe conditions specified in Part II. of this Consent Order

and in the Consent Order for Contract Manufacturer.

ooldentity" means any chemical or common name used to identify a chemical substances or

a mixture containing that substances.

"lmmediate use." A chemical substances is forthe o'immediate use" of aperson if it is

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

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

0ontainer.

"Mahufacture" msans to produce or manufacture in tlhe United States or import into.the

customs territory of the United States,

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

shemical substances, regardless of physical state or concentration, through all intended operations

of manufacture, ineluding the cleaning of equipment.

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

substances,
1

"Non-industrial use" means use other than at a facility where chernical substancess or

mixtures are manufactured or processed.

'*PMN substances" means the chemical substances described in the Premanufacture notice

submitted by the Company relevant to this Order.

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

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

processing, including the cleaning of equipment.

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

or the Good Laboratory Practice Standards at 40 CFR Part792 without prior or subsequent Agency

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

substances.'

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

conformity with the Qood Laboratory Practice Standards and EPA-approvsd protocols, are

inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of

the potential risk of injury to human health or the environment of the PMN substances.

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

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

to, nor environmental release of, the PMN substances during transport and storage ,

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

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

industrial, commercial, or consumer use.

"Waters of the United States" has the meaning set forth in 40 CFR 122,2,

"Work area" means a roorn or defined space in a workplace where the PMN substances is

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

*'IiVorkplace" means an establishment at one geographic location containing one or more

work areas.
ATTACHMENT B

NOTICE OF TRANSFER

OF

TOXIC SUBSTANCESS CONTROL .ACT

SECTION 5(e) CONSENT ORDER

Company (Transferor) "PMN Number

L Trassfer of,Mnnu&Sture Riehts. Effective on

otherwise transfer to

the Company did sell or

(*'Successor in Interest") the rights

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

was the subject of a premanufacture notice ("Ph{hl'o) and is governed by a Consent Order issued

by the U.S. Environmental Protection Agency ("EPA") under the authority of $5(e) of the Toxis

Substancess Control Act ("TSCA," l5 U.S,C. $260a(e)),

2. r*S..sJrnption,of Liability- The Successor in Interest hereby certifies that, as of the effective date

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

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

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

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

72a.22(aX3),

3. Con"fidp4tial BJ,S_in_eSs hfofmatjqlr* The Successor in lnterest hereby:

_ 

reasserts,

_ 

relinquishes, or

_-* modifies

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

14 of TSCA and 40 CFR part 2, for the PMN substances(s). Vfhere onreasserts" or o'relinquishes"

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

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

Transfer. Iuformation which has been previously disclosed to the public (e.g,, a chemical identity

that was not claimed as CBI hy the original submitter) would not subsequently be eligible for

confidential treatment under this Notice of Transfer.
ffifltf i vflil

OPPI CB I[

I0ll' JUL eh PH lr EE

IX{ITED S TATES EhTVIRONMENTAL PROTECTION AGENCY

OFFICE OF POLLUTION PREVENTION A}-iD TOXICS

REGULATION OF A NEW CHEMICAL SUBST,{}ICES

PENDINfi DEVELOPMENT OF INFORMATION

In the rnatter of; Premanufapture Notice Number :

ArrMaz Custom Chemicals P-12;i 15 and P-12-11S

Consent Order for Contract Manufacturer

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COITSEIYT ORDER

(a) $pope, ArrMaz Custorn Chemical ("the Contract Manufaturer") has entered into a contract

with Huntsman Corporation (*-the Company") to manufacture for the Company the chemical

substances P-12-l 15 and

l2-1I6 ("the

pMN substances") The requirements of this Order apply to all commercial manufacturing,

processing, distribution in commerce, use and disposal of these chemical substances in the United

States by the Contract Manufacturer, except to the extent that those activities are exernpted by

paragraph (b),

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

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

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

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

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

required in the Recordkeeping section of this Order'

(l) Export. Until the Contract manufacturer begins commercial manufacture of the PMN

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

processing or distribution in sommerce of the PMN substances solely for export in accordance

with TSCA gglz(a) and 12(b),40 CFR 720.3(s) and 40 CFR Part 7A7, However, once the

Contract Manufacturer begins to manufacture the PMN substances for use in the United States, no

further activity by the Contract Manufacturer involving the PMN suhstances are exempt as "solely

for export" even if some amount of the PMN substances are later exported. At that point, the

requirements of this Order apply to all activities associated with these PMN substances while in

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

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

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

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

rnanufacturing, processing, distribution in commerce, use and disposal of the PMN suhstances in

small quantities solely for research and developrnent in accordance with TSCA $5(hX3), 40 CFR

720,3(oc), and 40 CFR 72fi.36, The requirements of this Order also do not apply to

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

when manufactured solely for non*commercial research and development per TSCA $5(i) and 40

cFR 720.30(i).
;3

(3) Byproducts. The requirements of this Order do not applyto the PMN substances when

they are produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR

720,3(d) and in compliance with 40 CFR 720.30(9).

(a) No Separate Cornmercial 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 part,

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

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

with 40 CIR 720.22tbXI),

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

substances that have partitioned into oil or petroleum streams following use as an interfacial

tension reducer for enhanced oil recovery applications.

(c) Autpmatic Sunset. If the Contact Manufacturer has obtained for the PMN substances a Test

Market Exernption ("TME") under T$CA $s(hxl) and 40 CFR 720J8 or a Low Volume

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

and 40 CFR Tfi.SA{c)( I ) and (2) respectively, any such exemption is automatically rendered null

and void as of the effective date of this Consent Order.
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PRoHmIJIoN

As a condition of manufacturing the PMN substances fbr the ComPanY, the Contract

Manufacturer is prohibited from ffianufacturing (including importing), processing, distributing in

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

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

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

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

this Order,

HA4ABP CO.UMUIIIQATIAN qHSPRAM

(a)WrittenHTheContractManufacturershalldeve1opand

implement a written hazard communication program for these PMN substances in each workplace.

f'he written program will, at a minimum, describe how the requirements of this section for labels,

MSDSs, and other forms of warning material will be satisfied. The Contract Manufacturer must

make the written hazard communication program available, upon request, to all employees,

contractor employees, and their designated representatives. The Contract Manufacturer may rely

on an existing hazard communication program, including an existing program established under

the OSHA Hazard Communication Standard (29 CFR 1910.1200), to comply withthis paragraph
provided that the existing hazard cornmunication program satisfies the requirements of this

section. The written program shall include the following:

(l) A list of chemical substances known to be present in the work area which are subject to

a TSCA section 5(e) consent order signed by the Contract Manufacturer or to a TSCA section

5(aX2) SNUR at 40 CFR Part T2l,subpart E. The list must be maintained in each work area

where these PMN substances are known to be present and must use the identity provided on the

MSDS for the substances required under paragraph (c) of this section. The list may be compiled

for the workplace or for individual work areas. If the Contract Manufacturer is required either by

another Order issued under section 5(e) of TSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR

part7Zl, subpart E, to maintain a list of substances, the lists shatl be combined with the list under

this subparagraph.

(2) The methods the Contract Manufacturer will use to inform employees of the hazards of

non-routine tasks involving these PMN substances (e.g., cleaning of reactor vessels), and the

hazards associated with these PMN substances contained in unlaheled pipes in their work area.

(3) 'fhe methods the Contract Manufacturer will use to inform contractors of the presence

of these pMN substances inthe Contract Manufacturer's workplace and of the provisions of this

Order if emptoyees of the contractor work in the Contract Manufacturer's workplace and are

reasonably likely to be expased to these PMhl substances while in the Contract Manufacturer's

workplace.
6

(b) I,ab.pli4g,

(1) The Contract Manufacturer shall ensure that each container of the substances in the

workplace is labeled in accordance with this subparagraph (bxl).

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

(A) A statement of the health hazards(s) and precautionary measurs(s), if

nny, identified either in paragraph (t) of this section or by the Contract Manufacturer, for the PMN

substances,

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

recognized,

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

ffieasurs(s), if ffiy, identified either in paragraph (f) of this section, or by the Contract

Manufacturer, for the PMN substances.

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

identified either in paragraph (0 of this section, or by the Contract Manufasturer, forthe PMN

substances.

(ii) The Contract Manufacturer may use signs, placards, process sheets, batch

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

stationary process containersr as long as the alternative method identifies the containers to which it

is applicable and conveys information specified by subparagraph (bX1)(i) of this section, Any

written materials must be readily acsessible to the employees in their work arcas tfuoughout each

work shift,
'l *.

(iii) The Contract Manufacturer need not label portable containers into which the

PMN substances are transferred from labeled containers, and which are intended only for the

immediate use of the employee who performs the transfer.

(iv) The Contract Manufacturer shall not remove or deface an existing label on

containers of these PMN suhstances obtained from"persons outside the Contract Manufacturer

unless the container is immediately re-labeled with the inforrnation specified in subparagraph

(bXl)(i) of this section.

(2) The Contract Manufacturer shatl ensure that each container of the substances leaving

its workplace for distribution in commerce is laheled in accordance with this subparagraph (bxz).

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

(A) The information prescribed in subparagraph (bxlXi) of this section.

(B) The narne and address of the manufacturer or a responsible party who

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

emergency procedures.

(ii) The label shall not conflict withthe requirements of the Hazardous Materials

Transportation Act (18 U,S.C. l80l et. seq.) and regulations issued under that Act by the

Department of Transportation.

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

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

information may be repeated in other languages.

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

PMN substances in combination with any other substances that is either'subject to another TSCA
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section 5(e) Order applicable to the Contract Manufacturer, or subject to a TSCA section 5(aX2)

SNUR at 40 CFR Part 721, subpart E, or defined as a 'ohazardous chemical" under the OSHA

Hazard Communication Standard (29 CFR 1900.1200), the Contract Manufacturer may prescribe

on the label, MSDS, or alternative form of warning, the measures to control worker exposure or

environmental release which the Contract Manufacturer dstermines provide the greatest degree of

protection, However, should these control measures differ from the applicable measures required

under this Order, the Contract Manufactursr must seek a determination of equivalency for such

alternative control measures pursuant to 40 CFR 721.30 before prescribing thenr under this

subparagraph (bxs),

(6) If the Contract Manufacturer becomes aware of any significant new information

regarding the hazards of the PMN substances or ways to protect against the hazards, this nsw

information must be added to the label within 3 months from the time the Contract Manufacturer

becomes aware of the new information. If the PMN substances are not being manufactured,

processed, or used in the Contract Manufacturer's workplace, the Contract Manufacturer must add

the new information to the label before the PMN substances ars reintroduced into the workplace.

(c) Material-Ea&ty Data" Sheets.

(1) The Contract Manufacturermust obtain or dsvelop an MSDS forthese PMN

substances,

(2) The MSDS shall contain, at a minimum, the following infbrmation:

(i) The identity used on the container label of these PMN substances under this

section, and, if not claimed confidential, the chemical and common namss of the PMN substances,
I

If the chemical and common names are claimed confidential, generic chemical names must be

used.

(ii) physical and chemical characteristicq of the substances known to the Contract

Manufacturer, (e.g., vapor pressuren flash point),

(iii) The physical hazards of the substances known to the Contract Manufacturer,

including the potential for ftre, explosion, and reactivity'

(iv) The potential human and environmental hazards as specified in paragraph (f)

of this section,

(v) Signs and symptoms of exposure, and any rnedical conditions which are

expected to be aggravated by exposure to the PMN substances known to the Contract

Manufacturer.

(vi) The primary routes of exposure to the PMN substances.

(vii) precautionary measures to control worker exposure and/or environmental

release required by this Order, or alternative control rneasures which EPA has determined under 40

CFR ?21.30 provide substantially the same degree of protection as the identified control measures.

(viii) Any generally applicable precautions for safe handling and use of the PMN

substances which are known to the Contract Manufacturer, including appropriate hygienic

practices, protective measures during repair and maintenance of contaminated equipment, ancl

procedures for response to spills and leaks.

(ix) Any generally applicable control measures which are known to the Contract

Manufacturer, such as appropriate engineering controls, work practices, or personal protective

equipment.
1il

(x) Emergency first aid procedures known to the Contract Manufacturer.

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

(xii) The name, address, and telephone number of the Contrac,t Manufacturer or

another responsible party who can provide additional information on the chemical substances and

any appropriate emergency procedures.

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

Contract Manufacturer must mark the MSDS to indicate that no applicable information was found.

(4) Where multiple mixtures containing these PMN substances have sirnilar compositions

(i.e., the chemical ingredients are essentially the same, but the specific composition varies from

nrixture to mixture) and similar hazards, the Contract Manufacturer may prepare one MSDS to

apply to all of these multiple mixtures,

(5) If the Contract Manufacturer becomes aware of any significant new information

regarding the hazards of these PMN substances or ways to protect against the hazards, this new

information must be added to the MSDS within 3 months from the time the Contract Manufacturer

becomes aware of ttre new information. If these PMN substances are not being manufactured,

processed, or used in the Contrast Manufacturer's workplace, the Contract Manufacturer must add

the new information to the MSDS before these PMN substances are reintroduced into the

workplace.

(6) The Contract Manufacturer must ensure that persons receiving these PMN substances

from the Contract Manufacturer are provided an appropriate MSDS with their initial'shipment and

with the first shipment after an MSDS is revised. The Contract Manufacturer may either provide

the MSDS with the shipped containers or send it to the person prior to or at ttre time of shipment.
1" 1"

(7) The Contrast Manufacturer must maintain a copy of the MSDS in its workplace, and

must ensure that it is readily accessible during each work shift to employees when they are in their

work areas. ;

(8) The MSDS may be kept in any form, including as operating procedures, zurd may be

designed to cover groups of substances in a work area where it may be more appropriate to address

the potential hazards of a process rather than individual substances. However, in all cases, the

required information must be provided for the PMN substances and rnust be reaclily accessible

during each work shift to ernployees when they are in their work areas.

(9) The MSDS must be printed in English; however, the information rnay be repeated in

other languages.

(d) Employee Information andJrajninq. The Contract Manufacturer must ensure that ernployees

are provided with information and training on these PMN substances. This information and

training must be provided at the time of each employee's initial assignment to a work area

containing the PMN substances and whenever the PMN substances are introduced into the

employee's work area for the first tirne.

(1) The information provided to employees under this paragraph shall include:

(i) The requirements of this section.

(ii) Any operations in the work area where the PMN substances are present.

(iii) The location and availability of the written hazard communication program

required under paragraph (a) of this section, including the list of substances required by

subparagraph (aXl) of this section and MSDSs required by paragraph (c) of this section.
72

(2) The training provided to employees shall include:

(i) Methods and observations that may be used to detect the presence or release of

the substances in or from an employee's work area (such as exposure monitoring conducted by the

Contract Manufacturer, continuous monitoring devices, visual appearance, or odor of the

substances when being released).

(ii) The potential human health and environmental hazards of these PMN

substances as specified in paragraph (0 of this section.

(iii) The measures employees can take to protect themselves and the environment

ftom the substAnces, including specific procedures the Contract Manufacturer has implemented to

protect employees and the environment from sxposure to these PMN substances, including

appropriate work practices, omergency procedures, personal protective equipment, engineering

controls, and other measures to control worker sxposure andlor environmental release required

under this Order, or alternative control measures which EPA has determined under 40 CFR 721.30

provide the same degree of protection as the specified control measures.

(iv) The requirements of the hazard communieation program deve loped by the

Contract Manufacturer under this section, including an explanation of the labeling system and the

MSDS required by this section and guidance on obtaining and using appropriate hazard

information,

(e) De MinimiE.Concentrations. The requirernents of this Hazard Communication section do not

apply to quantities of the PMhtr substances that are (l) present in the wor.k area only as a mixture

and (2) at a soncentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or
r 1.3

volume if the PMN substances is identified as apotential carcinogen in paragraph (0 of the Hazard

Communication Program section of this Order). This exemption is not available if the Contract

Manufacturer has reason to believe that, during intended activities, the PMN substances in the

mixture may be reconcentrated above the 1.0 or 0.1 percent level, whichever applies. If this Order

contains New Chemical Exposure Limits provisions or Release to Water provisions that,

respectively, specify a NCEL concentration (ooTWA") or in-stream concentration ("N") Iess than

the de minimis concentration specified here, then this de minimis exemption does not apply to

those provisions.

(f) Il The

following human health and environmental hazard and precautionary statements shall appear on

each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) of this sestion:

(l) Environmental hazard staternents. These substances may be:

(i) toxic to fish.

(ii) toxic to aquatic organisms,

(2) Environmental hazard precautionary statements. Notice to users:

(i) disposal restrictions apPIY

(3) Human health hazard statements, This substance may cause:

(i) skin irritation.

(ii) serious eye damage

(4) Human hazard precautionary statements. When using this substance';
1"4

(i) avoid skin contact,

(ii) avoid breathing the substance.

(iii) avoid ingestion,

(iv) use skin protection.

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

prepared pursuant to paragraph (b) of this section must be followed by the staternent: "See the

MSDS for details."

. MAIr{.Uf'ApTURTNG

(a) ( I )Prohibition. The Contract Manufacturer shall not begin manufacture of the PMN substance

until the Contract Manufacturer or the Company receives a fully executed copy of the Consent

Order for Contract Manufacture from EPA,

{2) The Contract Manufacture shall not cause, encourage, or suggest the manufacture or

import of the PMN substances by any other person.

(3) Sunset Follqwins SNUR. Subparagraph (aX1) shall expire 75 days after promulgation

of a final significant riew use rule ("SNUR") governing the substances under section 5(a)(2) of

TSCA unless the Contract Manufacture is notified on orbefore that day of an action in a Federal

Court seeking judicial review of the SNUR. If the Contract Manufacture is so notified, paragraph

(a) shall not expire until EPA notifies the Contract Manufacture in writing that all Federal Court

astions involving the SNUR have been resolved and the validity of the SNUR affirmed-
15

(4) When EpA promulgates afinal SNUR forthese PMN substances and paragraph (aXl)

expires in accordance with subparagraph (aX2), the Contract Manufactuer shall notify each person

whom it causes, encourages or suggests to manufacfure the PMN substanses of the existence of the

SNUR,

(b) The Contract Manufacturer shall not manufacture P-12-115 other ttran as a chemical

intermediate to prepare an interfacial tension reducer for enhanced oil recovery and P-12-l l6 other

than as interfacial tension redusers for enhanced oil recovery.

PRqpESSING

(a) The Contract Manufacturer shall not process P- 12-115 other than as a chemical intennediate to

prspare an interfacial tension reducer for enhanced oil recovery and P- 12-116 other than as

interfacial tension reducers for enhanced oil recovery

USE

(a) The Contract Manufacturer shall not use P-1?-l l5 other than as a chemical intermediate to

prepare an interfacial tension reducer for enhanced oil recovery and P-12-l l6 other than as

interfacial tension reducers for enhanced oil recovery.

pJqIF,IBIJTI0I.'{

(a) Elport Notice Requiffiment. No later than the date of distribution, the Contract Manufacturer

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

issuance of this Consent Orderunder section 5(e) of TSCA, these PMN substances are subject{o
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the export notification requirements of TSCA section tz(b) and 40 CFR Part 707 Subpart D. Such

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

information: (l) the PMN numbers, and (2) either (A) the specific chemical identity of the PMN

subsrances, or (B) if the specific chemical identity is sonfidential, the generic chemical identity.

(b) Distributipn RequifpmpntS. (i) Except for quantities of the PMN substances that have

partitioned into oil or petroleum strearns following use as an interfacial tension reducer for

enhanced oil recovery applications or as provided in paragraph (c), the Contract Manufacturer

shall distribute the PMN substances outside the Contract Manufacturer only to a person who has

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

(1) Notify in writing any person to whorn it distributes these PMN substances that, due to

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

to the export notification requirements of TSCA section lz(b) and 40 CFR Part 707 $ubpart D.

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

information: (1) the PMN nurnber, and (2) either (A) the specific chemical identity of the PMN

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

(2) Not further distribute the PMN substances to any other person, other than for disposal,

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

following use as an interfacial tension reducer for enhanced oil recovery applicatioils,

(3) Comply with the same requirements and restrictions, if ntry, required of the Contract

Manufacturer in the Hazard Commnnication Program section of this Order.

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1?

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

Contract Manufacturer in the Disposal and Release to Water sections of this Order'

(5) Not use pMN P-12,1l5 other than as a chemical interrnediate to prepars an interfacial

tension reducer for enhanced oil and P-l2-116 other than as interfacial tension reducers for

enhanced oil recovsry;

(c) Lem.porary Transport and.Storasp,, Notwitl:standing paragraph (b), the Contract Manufacturer

may distribute the PMN substances outside the Contract Manufacturer for temporary transport and

storage in 'osealed containsrs" (defined for the purposes of this Order to exclude tank trucks,

tractor trailers, train cars or other delivery vehicles with attached tanks) provided the following

three conditions are met:

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

these pMN substances may be distributed only to the Company or a person who has given the

Contract Manufacturer the witten agreement required by paragraph (b).

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

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

substances are in the possession and control of the Contract Manufacturer or a person who has

given the Contrac,t Manufacturer the written agreement required by paragraph (b).

(3) The sealed containers must be labeled in accordance with paragraph (bxz) of the

Hazard Comrnunication Program section of this Order.
r8

(d) Recipient N.Qn-Cp$pliance.

(1) If, at any time after commencing distribution in commerce of these PMN substances, the

Contract Manufacturer obtains knowledge that a recipient or transporter of the substances has

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

or, after subparagraph (bXZ) expires in accordance with subparagraph (e)(1), has engaged in a

significant newuse of the PMN suhstances (as defined in 40 CFR Part'121, Subpart E) without

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

the substances to that recipient, unless the Contract Manufacturer is able to document each of the

following:

(a) That the Contract Manufacturer has, within 5 working days, notified the recipient in

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

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

submitting significant new use notices to EPA.

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

Contract Manufhcturer received from the recipient, in writing, a statement of assurance that the

recipient is aware of the terms of paragraph (b) of this Distribution section and will comply with

those terms, or is aware of the terms of the significant new use rules for the PMN substances and

will not engage in significant new usss without submitting significant new use notices to EPA.

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

(dX I )(b) of this Distribution section, the Contract Manufacturer obtains knowledge that the

recipienthas failed to comply with any of the conditions specified in paragraph (b) of this

Distribution section, or has engaged in a significant new uses of these PMN substances without
19

subrnitting a significant new use notice to EPA, the Contract Manufacturer shall ceass supplying

these pMN substances to that recipient, shall notify EPA of the failure to comply, and shall resume

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

(Z) If, at any time after commsncing distribution in commerce of the PMN

substances, EpA obtains knowledge (such as th,rough a TSCA Section 1l inspection or subpoena),

that arecipient of the substances has failed to comply with afly of the conditions specified in

paragraph (b) of the Distribution section or, after subparagraph (bX2) expires in accordance with

subparagraph (eXl), has engaged in a significant new use of the PMN substances (as defined in 40

CFR part TZl,Subpart E) without submitting a significant new use notice to EPA, EPA may notify

the Contract Manufacturer in writing that, despite the terms of this Order, EPA finds that the

distribution in commerce of the PMN substances will or may present an unreasonable risk of

injury to human health or the environment. EPA's notice may specify that the Contract

Manufacturer undertake certain actions conc€rning further testing, manufacture, processing,

distribution, use an#or disposal of the PMN substances to mitigate exposures to better characterize

the risks presented hy the PMN substances. Within 2 weeks from receipt of such a notice, the

Contract Manufacturer rnust cease all manufacture, processing, distribution, use and disposal of

the PMN substances, unless either:

(a) within 2 weeks frorn receipt of the EPA notice, the Contract Manufasturer complies with such

requirements as the notice specifies; or

(b) within 4 weeks from receipt of the EPA notice, the Contract Manufacturer submits to

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

imposed by EpA. The EpA will respond to the Contract Manufacturer, in writing, within 4 weeks
2A

of receiving the Contract Manufactursr's report, Within 2 weeks of receipt of EPA's written

response, the Contract Manufacturer shall comply with any requirernents imposed by EPA's notice

or revised response or, cease all manufacture, processing, distribution, use and disposal of the

PMN substances.

(e) Sunset Following SNUR. (l) paragraphs (aXl) of this Distribution section shall expire 75

days afterpromulgation of a final SNURs forthese PMN substances under section 5(aX2) of

TSCA, unless the Contract Manufacturer is notified on or before that day of an action in a Federal

Court seeking judicial review of the SNUR, If the Contract Manufacturer is so notified,

subparagraph (bX2) and (dX2) of this Distribution section shall not expire until EPA notifies the

Contract Manufacturer in writing that all Federal Court actions involving the SNUR have been

resolved and the validity of the SNUR affirmed

(2) When EPA promulgates a final SNUR for these PMN substances and subparagraphs (bXZ)

and (dX2) of this Distribution section expires in accordance with subparagraph (eXl), the Contract

Manufacturer shall notify each person to whom it distributes the PMN substances of the existence

of the SNURs. Such notification must be in writing and must specifically include all limitations

contained in the SNURs which are defined as significant new uses, and which would invoke

significant new use notification to EPA for the PMN substances. Such notice must also reference

the publication of the SNURs for this PMN substances in either the Fedef.al Begister or the Code

of Federal Regulations. After promulgation of SNURs and expiration of subparagraphs (bXz) and

(dxz), such notices may substitute for the writtsn agreements required in the introductory clause of

paragraph (b); so that, if the Contract Manufacturer provides such notices to the persons to whom
2L

it distributes the PMN substances, then the Contract Manufacturer is not required to obtain from

such persons the writtsn agreements specified in paragraph (b).

BmtEASp.To WAJEE

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

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

Manufacturer is prohibited from any predictable or purposeful release of the PMN substances, or

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

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

number of kilograms/day/site released

x 1000 = N parts per billion

receiving stream flow (million liters/day)

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

721.91,. I{owever,40 CFR 721.91(aXa} does not apply. Instead, if the waste stream containing

the PMN substances will be treated using biological treatment (activated sludge or equivalent) plus

clarification, then the amount of PMN substances rea$onably likely to be removed from the waste

stream by such treatment may be subtracted in calculating the number of kilograms released. No

more than 90 percent removal efficiency may be attributed to such treatment,

(b) In lieu of calsulating the quotient in subparagraph (lXa), monitoring or alternative calculations

may be used to predict the surface water concentration expected to result from the intended release

of the substances, if the monitoring procedures or calculations have been approved for such
?,2

purpose by EPA. EPA will review and act on a written request to approve monitoring procedures

or alternative calsulations within 90 days after such a request is received. The Agency will inform

the Contract Manufacturer of the disposition of such requests in writing and, where a request is

denied, will explain the reasons therefore,

rrr. Rs.p,pBilHs.EPrNc

(a) Records, The Contract Manufacturer shall rnaintain the following resords until 5 years after

the date they are created and shall make them available for inspection and copying by EPA in

accordance with section 1l of TSCA: '

(l) EXEtttp,tiq$,+, Records documenting thatthe PMN substances did in fact qualify for any

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

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

exemption being claimed by the Contract Manufacturer. Any amounts or batches of the PMN

substances eligible for the export only exemption in Section I, Paragraph (bXl) of this Order ars

exempt from all the requirements in this Recordkeeping section, if the Contract Manufasturer

maintains, for 5 years from the date of their creation, copies of the export label and export notice to

EPA, required by TSCA sections Iz(aXlXB) and 12(b), respectively, Any amounts or batshes of

the PMN substances eligible for the research and development exemption in Section I, Paragraph

(bxz) of this Order are exempt from all the requirements in this Recordkeeping section, if the

Contract lvlanufacturer maintains, for 5 years from the date of their creation, the records required

by 40 CFR 7ZA.7S(b). For any amounts or batches of the PMN substances claimed to be eligible
23

for any other exemption described in Section I, Paragraph (b) of this Order, the Contract

Manufacturer shall keep records demonstrating qualification for that exemption as well as the

records specified in paragraphs (2) and (3) below, but is exempt from the other recordkeeping

requirements in this Recordkeeping section;

tZ) Records documenting the manufacture volume of the PMN substances and the

corresponding dates of manufacture;

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

address, if different) of all persons outside the site of manufacture to whom the Contract

Manufacturer directly sells or transfers the PMN substances, the date of each sale or transfer, and

the quantity of the substances sold or transferred on such date;

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

(5) Records documenting establishment and implementation of the hazard communication

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

(6) Copies of labels required under the Hazard Commurication Program section of this

Order;

(7) Copies of Material Safety Data Sheets required by the Hazard Commurication

Program section of this Order;

(B) Records documenting compliance with any applicable manufacturing, processing, use?

and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections of

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

Order;
24

(9) Records dosumenting 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 Contract Manufacturer and is not reasonably ascertainable by the Contract

Manufacturer, the Contract Manufacturer must maintain other records which demonstrate

establishrnent and implementation of a program that ensures compliance with any applicable

di sposal requirements ;

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

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

Order;

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

section of this Oider, if applicable; and,

(12) The Contract Manufacturer shall keep a copy of this Order at each of its sites where

the PMN substanses are manufactured-

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

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

the Contract Manufacturer's sustomers,

(c) OMB Control Nt+ryber. Under the Paperwork Reduction Act and its regulations at 5 CFR Part

1320, particularly 5 CFR 1320.5(b), the Contract Manufacturer is not required to respond to this

"collection of information" unless this Order displays a currently valid control number from the

Office of Management and Budget ("OMB"), and EPA so informs the Contract Manufacturer.
4r

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

under currently valid OMB Control Number 2070-0012.

IY. BH,pJp$T$ FO R H,RE:INSPECTIq,I{ INF q RMArIQFi

(a) EPA's Beguest follnformatign. Pursuant to section 1 I of TSCA and 40 CFR 720.122,EPA

may occasionally conduct on-site compliance inspections of Contract Manufacturer facilities and

conveyances associated with these PMN substances. To facilitate such inspections, EPA personnel

may contact the Contract Manufacturer in advance to request information pertinent to the

scheduling and conduct of such inspections. Such requests may be written or oral. The types of

information that EPA may request include, but are not limited to, the following:

( I ) Expected dates and times when the PMN substances will be in production within the

subsequent l2 rnonths;

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

these PMN substances and may reasonably be exposed to these PMN substances;

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

with the PMN ,rb*t**es and may reasonably be exposed to the PMN suhstances;

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

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

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

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

conducting an inspection for that purpose.
ID

(b) Contract Manufactuler's Response. The Contract Manufacturer shall respond to sttch requests

within a reasonable period of time, but in no event laterthan 30 days after receiving EPA's

request. When requested in writing by EPA, the Contract Manufacturer's response shall be in

writing. Tp the extent the information is known to or reasonably ascertainable by the Contract

Manufacturer at the time of the request, the Contract Manufacturer's response shall demonstrate a

good faith effort to provide rcasonably accurate and detailed answers to all of EPA's requests.

(c) C.onf,dential Busine_ss Info{mation. Any Confidential Business Information ('*CBl") that the

Contract Manufacturer suhmits to EPA pursuant to paragraph (b) shall be protected in accordance

with $14 of TSCA and 40 CFR Part 2,

v. MqrlrHIsATI oN.AmU "RSVO CATION OF' SoN sENr qEDER

(a) P.etitiolts.

(l) The Contract Manufacturer may petition EPA at any time, based upon new information

on ttre environmental effects or environmental release of the PMN substances, to modify or revoke

substantive provisions of this Order.

(2) The exposures and risks identified by EPA during its review of the PMN substances

and the information EPA determined to be necessary to evaluate those exposures and risks are

described in the preamble to this Order. However, in determining whether to amend or revoke this

Order, EPA will consider all relevant information available at the time the Agency makes that
2'l

determination, including, where appropriate, any reassessment of the test data or other information

that supports the findings in this Order, an sxamination of new test data or other information or

analysis, and any other relevant information.

(3) EPA will issue a modification or revocation if EPA determines that the activities

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

will not result in significant or substantial human exposure or substantial environmental release in

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

effects of the PMN substances.

(a) In addition, the Contract Manufacturer may petition EPA at any time to make other

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

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

Order as issubd.

(b)'Modification.or Revocation by EBA. Based on study results describing in the paragraph (d) of

the Testing Section or if EPA becomes awars of information that the terms of the Consent Order

are not being adhered to by downstream users as described in paragraph (d)(2) of the Distribution

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

paragraphs.
2B

VH. EHTEQT.9,H, AfiH;.I,ENT I}FDEB

(a) Waiver. By consenting to the entry of this Order, the Contrast Manufacturer waives its rights

to file objections to this Order pursuant to section 5(e)(1XC) of TSCA, to receive service of this

Grder no later than 45 days before the epd of the review period pursuant to section 5(e)(1XB) of

TSCA, and to challenge the validity of this Order in any subsequent action, Consenting to the

entry of this Orcler, and agreeing to be bound by its terms, do not constitute an adrnission by the

Contract Manufacturer as to the facts or conslusions underlying the Agency's determinations in

this proceeding, This waiver does not affect any other rights that the Contract Manufacturer may

have under TSCA.

I

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Chernisal Control Division

A\&f_yrp;*x{tf

Date

Office of Poll,ution Prevention and Toxics

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Contract naan,uih*turer: d'W lt{w# & {*rSflar*t

ti{'w"rtq{ trt#
DEFINITIONS

Nate: The attachedContract Manufacture Order ffiay not contain same of the lerms defined

below.

"Chemical name" msans the scientific designation of a shemical substances in ascordance

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

nomenclature, or a narne which will clearly identify a chemical substances for the purpose of

conducting a hazard evaluation.

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

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

trade name, brand name, or gensric chernical name used to identify a chemical substances other

than by its chemical name.

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

tank, or the Iike that contains a haiardous chernical. For purposes of this section, pipes or piping

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

containers.

'oContract Manufacturer" means a person, outside the CompflIry, who is authorized to

manufacture the PMN substances under the conditions specified in Part II. of this Consent Order

and in the Consent Order for Contract Manufacturer.

o'Identity" means any chemical or common nams used to identify a chemical substances or

a mixture containing that substances.
I

"Immediate use," A chemical substances is for the "immediate use'o of a person if it is

under the control of and used only by, the person who transfemed it from a labeled container and

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

container.

"Manufacture" means to produce or manufacture in tlhe United States or import into the

customs tenitory of the United States.

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

chemical substances, rsgardless of physical state or concentration, through all intencted operations

of manufacture, including the cleaning of equiprnent.

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

substances.

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

mixtures are manufactured or processed.

'.PMN substancss" means the chemical substances described in the Premanufacture notice

submitted by the Company relevant to this Order.

'oProcess stream" means all reasonably anticipated transfer, flow, or disposal of a shemical

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

processing, including the cleaning of equipment.

"Scientifically invalid" means any signifisant cleparture from the EPA-approved protocol

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

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

PMN substances.

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

conformity with the fiood Laboratory Practice Standards and EPA-approved protocols, are

inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of

the potential risk of iiury to human health or the environment of the PMN substances.

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

long-term containment of the PMN substances, and from which there will be no human exposurs

to, nor environmental release of, the PMN substances during transport and storage.

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

substances, regardless of physical state or conaentration, ttuough all intended operations of

industrial, commercial, or consffiner use.

"Waters of the lJnited States" has the meaning set forth in 40 CFR 1,?2.2,
2

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

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

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

work areas.