### UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS REGULATION OF A NEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT OF INFORMATION

In thematterof: 

### ) PremanufactureNoticeNumber: ) ) 

# CONTAINS NO ) 

# CB ·



# 7)~ **oly** )



## ~ ) ) 

### P-13-0568 ) ) ) 

### ) )



### Consent Order and Determinations Supporting Consent Orderii 

### TABLE OF CONTENTS Preamble I. 

### Introduction II. Summary ofTerms ofthe 

### Order III. 

### Contents ofPMN IV. EPA's 

### Assessment of Risk V. EPA's 

### Conclusions ofLaw VI. Information Required to Evaluate Environmental Effects 

## Co€ en

t

**rd r**  "?,'\



## T~**~**

# OO I. 

### Scope o1 i\pp 

## lc bility and 

### Exemptions II. 

### Terms ofManufacture, Processing, Distribution in Commerce, Use, and 

### Disposal Pending Submission and 

### Evaluation ofInformation III. 

### Reoordkeeping IV. Successor Liability Upon Transfer ofConsent Order V. Modification and

### Revocation ofConsent Order 

### VI. Effect ofConsent Order Attaclunent A

- Definitions Attachment B - 

### Notice ofTransfer ofConsent Orderiii 

## PREAMBLE I. INTRODUCTION Under the authority of§ 5(e) oftheToxic Substances Control Act ("TSCA") (15 U .S.C. 2604(e)), the Environmental Protection Agency ("EPA" or "the Agency'') issues the attached Order, regarding premanufacture notice 

### C'PMN") P-13-0568 for the chemical substance
("the 

### PMN substance") submitted by ("the Company"), to take effect upon expiration ofthe PMN review period. The Company submitted the PMN to EPA pursuant to 

### § 5(a)(l) ofTSCA and 40 CFR Part 720. Under§ 

### 15 ofTSCA, it is unlawful for any person to fail or refuse to comply 

### with any provision 

### of§ 5 or any order .issued under 

### § 5. Violators may be subject to various penalties and to both criminal and civil liability pursuant to 

### § 

### 16, and to specific enforcement and seizure pursuant to§ 17. In addition, chemical substances subject to an Ol'der issued under§ 5 ofTSCA, such as this one, are subject to the§ 12(b) export notice requirement.


### II. SUMMARY OF TERMS OF TH.E 

### ORDER The Consent Order for this PMN substance requires the Company to: (a) label the PMN substance and provide Material Safety Data Sheets ("MSDS") and worker training in accordance with the provisions oftheHazard Communication Program section;(b) not use the PMN substance other than as applications iv enhanced oil recovery

(c) distribute the 

### PMN substance only to 

### a person who agrees to follow the same restrictions 

### and to not further distribute the PMN substance until it has been partitioned into oil or petroleum streams following use as ] enhanced oil recovery applications;
(d) complywith the Release 

### to Water provisions; and
(e) maintain certain records.



### III. CONTENTS OF PMN By signing this Order, the Company represents that it has carefully reviewed this document and agrees that all information herein that is claimed as confidential 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 information contained within the brackets.
Confidential Business Information Claims**(Bruck~.::ted** in the Prcnmhlu nut! Order): Chemical identity, Company Name, Production Volume, Uses, Processing informationv

Generic: benzenesulfonic acid, dimethyl-, alkyl derivatives, sodium salt ] enhanced oil recovery applications Test Data Submitt ed with the PMN:
• Biotic Degradation (Modified Sturm Test) Evaluation, In 

### An Aqueous Medium, ofthe "Ultimate" Biodegradability on an analog • Salmonella-E. Coli/Mammalian Microsome Reverse Mutation Assay • Determination ofKoc Coefficient Following OBCD Guideline 121 • FTIR spectrum ofthe PMN substance • Acute Dermal Toxicity Study in Rabbits • Skin Sensitization Study in Guinea Pigs 

### IV. EPA4

### S ASSESSMENT OF RISK The following are EPA's predictions regarding the probable toxicity and environmental releases ofthe PMN substance, based on the infonnation currently available to the Agency.

Environmental Effects Summary: Based on test data on the chemical substance itself, EPA identified the following concentrations of
concern: Chronic 

### (20 days ofexceedance or greater): 4 part per billion ("ppb") Acute (less than 20 days ofexceedance): 84ppb

Human Health Effects Summary:vi Absorption is poor from the skin, moderate from the GI 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 ofthe compounds and analogues. Rabbit dennal study indicated potential for skin irritation.

Environmental Re1ease Summarv: During the initial review ofthe PMN that applied genetic engineering scenarios published byEPA relevant to the notified usc, EPA assessed the following releases and exposures ofthe PMN 

### substance.

#Sites Workers (#/site) Exposure (days/year) Dermal Exposure (mglday) Inhalation Exposure (mglday) · Drinking Water Exposure (mg/day) Releases (days/year) Manufacture 

### Processing/Use



# ..vii Release to Water 

# - • (kg/day) Surface Water Up to. Up to. Concentration (ppb) Days .Exceeding 1 50 Concern Level

As part ofthis Consent Order, the Company has agreed to limit anypredic table orpurposeful release ofthe

### PMN substance, or any waste stream from manufacturin?, processing, and use containing the PMN substance, into the waters ofthe United States that would result in surface water concentrations exceeding 4 parts per billion ("ppb"), when calculated using the methods described in 40 CFR 721.91. Except for quantities 

### ofthe PMN substance that have partitioned into oil or petroleum streams following use as ] enhanced oil recovery applications, the Company shall distribute the PMN substance outside the Company only to a person who**h~s** agreed in writingprior to the date ofdistribution, to, among other requirements, to also abide by 

### this water release trigger and shall maintain such agreements on 

### file for inspection by the Agency.



### V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine the potential for ecological toxicity and enviromnental fate from human health and env1ronmental release ofthe 

### .PMN substance. 

### EPA therefore concludes,viii 

### pursuant to§ S(e)(l)(A)(i) ofTSCA, that the infonnat ion available to the Agency is insufficient to pennit a reasoned evaluation ofthe environmental effects ofthe PMN substance. (b) In light ofthe potential risk ofecological tox.icity and human health posed by

### the uncontrolled manufacture , processing, distribution in commerce, use, and disposal ofthe PMN substance, EPA has concluded, pursuant to§ 5(e)(1){A)(ii)(I) ofTSCA, that uncontrolled manufacture processing, distribution in commerce, use, and disposal ofthe PMN substance may present an unreasonable risk ofinjury to the environment.
.



### VI. INFORMATION REQUIRED TO EVALUATE ENVIRONMENTAL EFFECTS
Triggered Testing. The Orderprohibits the Company from exceeding a specified production volume unless the Company submits the information described in the Testing section of this Orderin accordance with the conditions specified 

### in the Testing section.UNITED STATES ENVIRONMENTAL PROTECTION AGEN CY WASHINGTON, D
.C. 20460



## CONSENT ORDER OFfiCE OF CHEMI CAL SAFETY AND POLLUTION PREVENTION

(a) Scope. The requirements ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe chemical substance
("the PMN substance") in the United States by the ("the C9mpany"), except to the extent that those activities are exempted byparagraph (b).
(b) Exemptions. Manufacturing, processing, distribution in commerce, usc and disposal ofthe PMN substance is exempt from the requirements ofthis Order (except the requirements in the Recordkeeping and SuccessorLiability Upon Transfer OfConsent Order sections) only to the extent that (1) these activities are conducted 

### in full compliance with nll applicable requirements of the following exemptions, and (2) such compliance is documentedby appropriate rccordkecping as required in the Recordkceping section of this Order. 

### (1) Export. Until the Companybegins commercial manufacture ofthePMN substance for
use in the United States, the requireme nts ofthjs Order do not apply to manufacture, processing or

Internet Address (URL) • ht1p:l lwww epa gov Recycled/Recyclable • Printed w11h Vegetable Oil eased Inks on 100% Postc:onsumer. Process Chlorine Froe Recycled Paper• 2 c11stribution 

### ill commerce ofthe PMN substance solely for export .in accordance with TSCA §§ 12(a) and 12(b ), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to manufacture the'PlvtN substance for use in the United States, no further activity 

### by the Company involving the PMN substance is exempt as "solely for exp01i'' even 

### ifsome amount ofthe PMN substance is later exported. At that point, the requirements ofthis Order apply to all activities associated 

### with the PMN substance while in 

### the territory oftheUnited States. Prior to leaving U.S. tcnitory, even those quantities or batches ofthe PMN substance that are destined for expolt
are subject to terms ofthe Order, and cow1t towards any pTOduction volume test triggers in the Testing section ofthis Order. (2) Researcn & Development ("R&D"). The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance in small quantities solely for re..o;;earch and developmentin accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720
.36. The requirements ofthis Order also do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance when manufactured solely for non-commercial research and development per TSCA §5(i) and 40 

### CFR 720.30(i)
. (3) Byproducts. The requirements ofthis Order do not apply to the PMN substance when 

### it is produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). (4) No Separate Commercial Purpose. The requirements ofthis Order do not apply to the PMN substance when it is manufactured, pursuant to any ofthe exemptions in40 CFR 720.30(h), with no commercial purpose separate fi:om the substance, mixture, or article ofwhich it is a part.- 3

- (5) lmported Articles. Therequirements of

### this Order do not apply to the PMN substance when it is imported 

### as part of

### an "article" 

### as defined at 40 CFR 720.3(c) and in compliance with 40 CPR 720.22(b)(l). (6) Partitioned
. The requirements ofthis Order do not apply to quantities ofthe PMN substance that have partitioned into oil or petroleum streams following use as

- ] enhanced oil recovery applications.
(c) Automatic Sunset. Ifthe Companyhas obtained for the PMN substance a Test Market Exemption ("TME") under TSCA §S(h)(l) and 40 CFR 720.38 or a LowVolumeExemption ("LVE") or Low Release and ExposureExempt ion ("LoREX") under TSCA §5(h)(4) and 40 CPR 723.50(c)(l) and (2) respectively, any such exemption is automaticallyrendered null and void as ofthe effective date ofthis Consent Order.- 4

- 

### II. TERMS OFMANUFACTURE, PROCESSING, DISTRIBUTIONIN COMMERCE, USE, 

### AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION PROHIBITION The Company is prohibited from manufacturing, processing, distributing in commerce, using, or disposing ofthe PMN substance in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe environmental effects ofthe substance, and thecompletion ofEPA's review of, and regulatory action based on, that information, except in accordance with the conditions described in this Order. 

### TESTING (a) Section 8(e) 

### Reporting. Reports ofinformation on the PMN substance which reasonably supports the conclusion that the PMN substance presents a substantial1isk ofinjury to health orthe environment and which isrequired to be reported under TSCA section 8(e) shall reference the appropriate PMN identification number for this substance and contain a statement that the substance is subject to this Consent Order. Additional information regarding section 8(e) reporting requirements can be found at www.epa.gov/oppt/tsca8e.
(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA Monitoring Assistance and Media Programs Division (2227

### A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 

### Pennsylvania Avenue, N.W., Washington, D.C. 20460, 

### ofthe following information within 10 

### days ofscheduling any study- 5

- 

### required to be**perform~ purs~ant**  

### to this**Ord~,** 

### or within 15 days after the effective date of

### this Order, whicheverislater: (1) The date when the study is scheduled

# to commence; (2) The name**an~** 

### address ofthe laboratory which will conduct the study; (3) The name and telephone number ofaperson at the Company orthe laboratozy whom EPA may contact**regard~g** 

### the study; and, ( 4.) The appropriate PMN identification number·for each substance and a statementthat the substance**i~** 

### subjectto this Consent Order. (c) Good Laboratory Practice Standards and Test Protocols. Each studyperfonned to address the risks identified in

### this Ordermustbeconducted according to TSCA Good Laboratory Praptice Standards at 40 CPR Part 

### 792 and using method9logies generally accepted in

## the relevant

. scientific community atthetime the study isinitiated. Before startingto 

### conduct any study

### that will use 

## amodified version ofa puljlished test 

### gui

_ deline, the CoiQpany tnilst 

### submit written test protocols to EPA for review**(~ubmission** 

### ofwritten testprotocols is optional for

- tests that are to be**cond~cted** 

### llsing unmodified published test gUidelines). Protocols must be submitted as a support



## . 

## . documentfor the**P~,** 

### using**~e** 

### procedures set out in

### 40 CFR 

### 720.40. EPA 

### will
_ respond to the

. . , 

# . Company within 4 

### weeks ofreceiving the**wri~en proto~ls** 

### .. EP. A reViC:W ofa**te~t** 

### protocol do· es not mean pre-acceptance oftest'results. (d) Triggered Testing 

### Requirements. ·The Company is prohibited from manufacturing the 

## PMN**su~stance** 

### at volumes greater- 6
- 

### the Notice ofCommencement (''the production limit"), unless the Company conducts the following studies on the PMN substance and submits all final reports and underlying data in accordance with 

### the conditions specified in this Testing section. Production Limit Fish early life stage test Daphnid chronic toxicity test Test Guideline OPPTS 850
..1400 OPPTS 850.1300
(e) Test Reports . The Company shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPA the results ofany interim phase ofeach study; and (3) submit the firial report ofeach study (with an additional sanitized copy, if confidential business infonnation is involved) and alltmderlying data ("the report and data") to EPA prior to exceeding the applicable production limit. The final report and data must be submitted as a support document for the PMN, using the procedures set out in 40 CFR 720.40. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting," "Data and Reporting," and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clear that the submission ofsuch infonnation is mandatory. EPA will require. the submission ofraw data such as slides and laboratory notebooks only ifEPA finds, onthe basis ofprofessional judgment, that an adequate evaluation ofthe study cannot take place in the absence ofthese items.- 7
- (f) Testing Waivers. The Companyis not required to conduct a study specified in paragraph (d) ofthis Testing section

### ifnotified in writing by

### EPA that 

### it is unnecessary to conduct that study.
(g) Equivocal Data. If

### EPA finds that the data generated by a study are scientifically equivocal, the Company may continue to manufacturethe 

### PMN substancebeyond the applicable production limit. To seek relieffrom any otherrestrictions ofthis Order, the Company may make a second attempt to obtain unequivocal databy reconducting the study under the conditions specified in paragraphs (b), (c), and (e) (except that the study may be submitted after reaching the applicable pr oduction limit). The testing requirements may be modified, as necessary to penn

### i t a reasoned evaluation ofthc risks presented by

### the PMN substance, onlyby mutual consent of

### EPA and the Company.
(h) EPA Determination ofInvalid Data (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's !eceipt ofa test report and data, the Company receives written notice that EPA finds that the data generated by
a study are scientifically inva1id, the:: Company is prohibited from further manufacture ofthe PMN substancebeyond the applicable production limit. (2) The Companymay continue to manufacture the PMN substancebeyond t he applicable production limit 

### only ifso notified, in writing, by EPA inresponse to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) Ifthere is sufficient time to reconduct the study in compliance with paragraphs (b), (c), and (e) before exceeding the production limit specifiedin paragraph (d), the Company

### - s - may reconduct the study. 

### Ifthere is insufficient time to reconduct the study in compliance with paragraphs (b), (c), and (c) before exceeding theproduction limit specified in paragraph (d), the Company may exceed theproduction limit, but must otherwise comply with paragraphs (b), (c), and (e), and shall submit the report and datato EPA within a reasonable period oftime, all as specifiedbyEPA in the notice described in subparagraph (h)(I). EPA

### will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data. (ii) The Company may, within 4 weeks ofreceiving from EPA thenotice described in subparagraph (h)(l), submit to EPA a Wl'itten report refuting EPA's finding. EPA will respond to the**Company~** in writing, within 4 weeks ofreceiving the Company's report.
(i) Company DetelJllination ofinvalid Data. (1) Except as described in subparagraph (i)(2), ifthe Companybecomes aware that circumstances clearly beyond the control ofthe Company or laboratory will prevent, orhave prevented, development ofscientifically valid data under the conditions specified in paragraphs (c) and (e), the Company remains prohibited fi·om further manufacture ofthe PMN substance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearly beyond the.control ofthe Company or laboratory will cause orhave caused development ofscientifically invalid data. EPA will notify the Company of

### its response, in writing, within 4 weeks ofreceiving the Company's report. EPA's written response may either:- 9
.. (i) allow the Company to continue to manufacture the PMN substance beyond the applicable production limit, or (ii) require the Company to continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c),**~d** (e), 

### ifthere is sufficient time to conduct orreconduct the study and submit the report and data to EPA before exceeding theproduction limit specified in paragraph (d). Ifthere is insufficient time for the Company to comply with paragraphs (b), (c), and (e) before exceeding the production limit specified in paragraph (d), the Company may exceed the production limit, but must otherwise comply with paragraphs (b), (c), and (e), and shall submit the report and data to EPA within a reasonable period oftime, all as specified byEPA in the notice described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company's report and data, as to whether the Company may continue to manufacture beyond the applicable production limit. (j)**Unrea~onable** Risk. EPA maynotify the Company in writing that EPA fmds that the data generated by a study are scientifically valid and unequivocal and indicate that, despite the te1ms of this Order, the PM:N substance 

### wit! or maypresent an unreasonable risk ofinjury to human health
or the environment. EPA's notice may specify that the Company undertake certain actions concerning further testing, manufacture, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposures to or to better characterize the risks presented bythe PMN substance. Within 2 weeks from receipt ofsuch a notice, the Company must cease all manufacture, processing, distribution, use and disposal ofthe PMN substance, unless either:**~** 10

- 

### (1) within 2 weeks from rece ipt ofthe EPA notice, the Company complies with such requirements
as the notice specifies; or (2) within 4 weeks from receipt ofthe EPA notice, the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness ofany additional requirements imposedby EPA. The Company may continue to manufacture, process, distr ibute, use and dispose ofthe PMN substance in accordance with the terms ofthis Order pending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks of receiving the Company's report. Within 2 weeks ofreceipt ofEPA's written response, the Company shall comply with any requirements imposed by EPA's response or cease all
manufactw·e, processing, distribution, use and disposal ofthe PMN substance.
(k) .Pther Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continue to obey all the terms ofthis Consent Order until otherwise notified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modifyor revoke provisions ofthis Consent Orderpursuant to Part VI. ofthis Consent Order.

HAZARD COMMUNICATION 

### PROGRAM (a) Written Hazard Communication Program. The Company shall develop and implement a written hazard communication program for the PMN substance in each workplace. The written program will, at a minimum, describe how the requirements ofthis section for labels, MSDSs, and other forms ofwarning material will be satisfied. The Company must make the written hazard- 11 - communication program available, upon request, to all employees, contractor employees, and their designated representatives. The Company may rely on an existinghazard communication program, including an existing program established under the OSHA Hazard Communication Standard (29 CFR 191 0.1200), to complywith this paragraph provided that the existing hazard communication program satisfies the requirements oftl1is section. The written program shall include the following: (I) A list ofchemical substance known to be present in the work area which are subject to
a TSCA section 5(e) consent order signed by the Company or to a TSCA section 5(a)(2) SNUR at 40 CPR Part 721, subpart E. The listmust be maintained 

### in each work area where the PMN substance is known to bepresent and must usc the identity provided on the MSDS for the substance required under paragraph (c) ofthis section
. The list may he compiled for
. the workplace
or for individual work areas. 

### Ifthe Company isrequired either by another Order issued under section 5(e) ofTSCA, or bya TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to maintain a list ofsubstance, the lists shall be combined with the list under this subparagraph. (2) The methods the Company will use to inform employees ofthe hazards ofnon-routine tasks involving the PMN substance (e.g., cleaning ofreactor vessels), and the hazards associated with the PMN substance contained in · unlabeled pipes in theirwork area. (3) The methods the Company will use to inform contractors ofthe presence ofthe PMN substance 

### in the Company's workplace and ofthe provisions ofthis Order 

### ifemployees ofthe contractor work in the Company's workplace and are reasonably likely to be exposed to the PMN substance while in the Company's workplace... 12

- (b) Labeling. (1) The Company shall ensure that each container ofthe substance in the workplace is labeled in accordance with this subparagraph 

### (b)(l). (i) The label shall, at a minimum, contain the following information: (A) A statement ofthe health hazards(s) and precautiomuy measure(s), if any, identified either in paragraph (f) ofthis section or by the Company, for the 

### .PMN substance. (B) The identityby which the 

### PMN substance may be commonly recognized. (C) 

### A statement ofU1e environmental hazard(s) and precautionary measure(s), ifany, identified either in paragraph (f) ofthis section, or by the Company, for the 

### PMN substance. (D) A statement 

### ofexposure and precautionary measure(s), 

### ifany, identified either inparagraph (f) ofthis section, or by the Company, for the PMN substance. (ii) 

### The Company may use signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu of**af~xing** labels to individual stationary process containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by'subparagraph 

### (b)(l)(i) ofthis section. Any written materials mustbereadily accessible to the employees in their work areas throughout each work shift. (iii) The Company need not label portable containers into which the PMN substance is transferred from labeled containers, and which are intended only for the immediate
use ofthe employee who performs the u·ansfer
.- 13

- (iv) The Company shall not remove or deface an existing label on containers ofthe PMN substance obtained from persons outside the Companyunless the container is**immediat~ly** re-labeled with the information specified in subparagraph (b)(l)(i) ofthis section. (2) The Company shall ensure that each container ofthe substance leaving its workplace for distribution in commerce is labeled in accordance with this subparagraph (b)(2). (i) The label shall, at a minimum, contain the following infonnation: (A) The information prescribed in subparagraph (b)(l)(i) ofthis section. (B) The name and address ofthe manufacturer or a responsible party who
can provide additional information on the substance for hazard evaluation and any appropriate emergency procedures. (ii) The label shall not conflict with the requirements ofthe Hazardous Materials Transportation Act (18 U.S.C. 1801 et. seq.) and regulations issued under that Act by the Department ofTransportation. (3) The label, or alternative forms ofwa:ming, shall be legible and prominently displayed. (4) The label, or alternative fonns ofwarning, shall be printed in English; however, the information may be repeated 

### in other languages. (5) Ifthe label or alternative form ofwarning is to be applied to a mixture containing the PMN substance 

### in combination with any other substance that is either subject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CPR Part 721, subpart E, or defined as a "hazardous chemical" under the OSHA Hazard Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS,
or alternative form ofwarning, the measw-es to control worker exposure or environmental release- 14

- which the Company detennines provide the greatest degree ofprotection. However, should these control measures differ from the applicable measures required under this Order, the Company must seek a determination ofequivalency for such alternative control measures pursuant to 40 CFR 721.30 before prescribing them under this subparagraph (b)(5). 

### (6) Ifthe Company becomes aware ofany significant new information regarding the hazards ofthe 

### PMN substance or ways to protect against the hazards, this new information must be added to the label within 3 months from the time the Company becomes aware ofthe new information. Ifthe 

### PMN substance is not being manufactured, processed, or used in the Company's workplace, the Company must add the new information to the label before the PMN substance is reintroduced into the workplace.
(c) Matetial Safety Data Sheets. (1) The Company must obtain or develop 

### an MSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: 

### (i) The identity used on the container label ofthe PMN substance under this section, and, ifnot claimed confidential, the chemical and common name ofthe PMN substance
. Ifthe chemical and common names 

### are claimed confidential, gene1ic chemical names must be used
. 

### (ii) Physical and chemical characteristics ofthe substance known to the Company, (e.g., vaporpressure, flash point). 

### (iii) The physical hazards ofthe substance known to the Company, including the potential for fire, explosion, and reactivity.- 1 5

- 

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

### ofthis section. (v) Signs and symptoms ofexposure, and any medical conditions which are expected to be aggravated by exposure to the PMN substance known to the Company. (vi) 

### The primary routes ofexposure to the PMN substance. (vii) Precautionary measures to conh·ol worker exposure and/or environmental release required by this Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide substantially the same degree ofprotection as the identified control measures. (viii) Any generally applicable precautions for safe handling and use ofthe PMN substance which are known to the Company, including appropriate hygienic practices, protective
measures**duri~g** 

### repair and maintenance ofcontaminated equipment, and procedures for response to spills and leaks. (ix) Any generally applicable control measures which arc known to the Company, such as appropriate engineering controls, work practices, orpersonal protective equipment. (x) Emergency first aid procedures known to the Company. (xi) The date ofpreparation ofthe MSDS or ofits last revision. (xii) The name, address> and telephone
.number ofthe Company or another responsible party who can provide additional infonn.ation on the chemical substance and any appropriate emergency procedures. (3) Ifno relevant information is found orknown for any given categoryon the MSDS> tbQ Company must mark the MSDS to indicate that no applicable infonnation was found.- 16

- (4) Where multiple mixtures containing the PMN substance have similar compositions (i.e., the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of these multiplemixtures. (5) Ifthe Companybecomes aware ofany significant new information regarding the hazards ofthe PMN substance or ways to protect against the hazards, this new information must be added to the MSDS within 3 months from the time the CQmpanybecomes aware ofthe new information. Ifthe 

### PMN substance is not beingmanufactured, processed, or used in the Company's workplace, the Company must add the new infonnation to the MSDS before the 

### PMN substance is reintroduced into the workplace. (6) The Company must ensure that persons receiving the PMN substance from the Company are provided 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 tlle time ofshipment. (7) The Company must maintain a copy ofthe 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) TheMSDS may bekept in any form, including as operatingprocedures, and may be designed to cover groups ofsubstance in a work area where 

### it may be more appropriate to address the potential hazards ofa process ra'ther than individual substance. However, in all cases, the required information must· be provided for the PMN substance and must bereadily accessible during each work shift to employees wllen they are in their work areas.- 17
- (9) TheMSDS must be printed in English; however, the information mayberepeated in other languages.
(d) Employee Information and Training. The Company must ensure that employees areprovided with information and training on the PMN substance. This information and training must be provided at the time ofeach employee's initial assignment to a work area containing the PMN substance and whenever the PMN substance is introduced into the employee's work area for the first time. (1) Theinformation provided to employees under this paragraph shall include: (i) Therequirements ofthis section. (ii) Any operations in the work area where the 

### PMN substance is present. (iii) The location and availability oflhc written hazard communication program required underparagraph (a) ofthis section, including the list ofsubstance required by
subparagraph (a)(]) ofthis section and MSDSs required byparagraph (c) of this section. (2) The trainingprovided to employees shall include: (i) Methods and observations that may beused to detect the presence orrelease of the PMN substance in or from an employee's work area (such as exposure monitoring conducted by the Company, continuous monitoring devices, visual appearance, or odor ofthe substance when being released)
. (ii) Thepotential human health and environmental hazards ofthe PMN substance
as specified in paragraph 

### (t) ofthis section.- 16

- (iii) The measures employees can take to protect themselves and the environment from the PMN substance, including specificprocedures the Company has implemented to protect employees and the environment fi·om exposw·e to the PMN substance, including appropriate work pradices, emergency procedures, personal protective equipment, engineering controls, and 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 721.30 provide the same degree ofprotection as the specified control measures. (iv) Therequirements ofthe hazard communication program developed by the Company under this section, including an explanation ofthe labeling system and the MSDS required bythis section and guidance on obtainjng and using appropriate hazard information.
(e)**D~** Minimis Concentrations. The requirements ofthis Hazard Communication section do not apply to quantities ofthe PMN substance that are (1) 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 ifthe PMN substance is identified as a potential carcinogen in paragraph (f) ofthe Hazard Communication Program section ofthis Order). This exemption is not available 

### ifthe Company )Jas reason to believe that, during intended activities, the PMN substance in themixture maybe reconcentrated above the 1.0 or 0.1 percent level, whichever applies. Ifthis Order contains New Chemical Exposure Limits provisions or Release to Water 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.- 19

- (() Hun:tan Health, Envir_onmental.Hazard, Exposure, and Precautionary Statements. The following human health and environmental hazard and precautionary statements shall appear on each label as specified in paragraph (b) and the MSDS as specifiedinparagraph (c) ofthis section: 

### (l) Environmental hazard statements. These substance may be: (i) toxic to fish. (ii) toxic to aquatic organisms. (2) Environmental hazard precautionary statements. Notice to users: (i) disposal restrictions apply. (3) Human health hazard statements. This substance may cause: (i) skin irritation. (ii) serious eye damage. 

### (4) Human hazardprecautionary statements. When using this substance: (i) avoid skin contact. 

### (ii) avoid breathing the substance. (iii) avoid ingestion. (iv) 1.1se skin protection. (5) Thehuman health, environmental hazard andprecautionary statement on the label prepared pursuant to paragraph (b) ofthis section mustbe followed by the statement: "See the MSDS for details."- 20

- MANUFACTURING 

### (a)(l) Prohibition. The Company shall not cause, encourage, or suggest the manufacture ofthe PMN substance by any otherperson. (2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days afterpromulgation ofa final significant new use rule ("SNUR") governing the PMN · substance under section 5(a)(2) ofTSCAunless the Company is notified on or before that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, subparagraph (a)(l) shall not expire until EPA notifies the Companyin writing that all Federal Court actions involving the SNURhavebeen resolved and the validity ofthe SNUR affinned. (3) Notice ofSNUR. When EPA promulgates a final SNUR for the PMN substance and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each personwhom it 

### causes, encourages or suggests to manufacture the PMN substance ofthe existence ofthe SNUR
. (b) The Company shall not manufacture the PMN substance other for use than as

- ] enhanced oil recovery applications.

PROCESSING 

### (a) The Company shall not process the PMN substance other for use than as

- enhanced oil recovery applications.- 21

- !}.§I (a) The Company shall not usc the PMN substance other than as enhanced oil recovery applications. 

### DISTRIDUTJOI'j (a) Exp.9rt_Notice Requirement. No later than the date ofdistribution, the Companyshall notify in writine any person to whom it distributes the PMN substance that, due to the issuance ofthis Consent Order

### under section 5(c) ofTSCA, the PMN substance is subject to the export notification 

### req11ircments ofTSCA section 12(b) and 40 CFR Part 707 Subprut 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 ofthe PMN substance, or (B) ifthe specific chemical identityjs confidential, the generic chemical identity.
(b) Distribution Requirements. (i) Except for quantities ofthe PMN substance thathave partitioned into oil orpetroleum streams following use as enhanced 

### oil recovery applications 

### or as provided 

### in paragraph 

### (c), the Company shall distribute the 

### PMN substance outside the Companyonly to a person who has agreed in writing prior to the date of distribution, to: (1) Notify in writing any person to whom 

### it distributes the PMN substance that, due to the issuance ofthis ConsentOrder under section 5(e) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in the form in which it appears in this Consent Order, the following- 22

- information: (1) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Not further distribute the PMN substance to any other person, other than for disposal, except for quantities ofthe

### PMN substance that have partitioned into oil orpetroleum streams following use as enhanced oil recovery applications. (3) Comply with the same requirements and restrictions, 

### ifany, required ofthe Company 

### in the Hazard Communication Program section ofthis Order. (4) Comply with the same environmental release restrictions, ifany, required ofthe Company in the Disposal and Release to Water sections ofthis Order. (5) Not use the PMN substance other than as described in the PMN;
(c) Jem);!Or.M.)' Transport and Storage. Notwithstanding paragraph (b), the Company may distribute the 

### PMN substance outside the Company for temporary transport and storage in "sealed containers" (defined for the purposes ofthis Order to exclude 

### tank trucks, tractor trailers, train
cars or other delivery vehicles with attached tanks) provided the following three conditions are met: (1) Subsequent to any such exempt temporary transport or storage ofsealed containers, the PMN substance may be distributed only to the Company or a person who has given the Company thewritten agreement required by paragraph (b). (2) Anyhuman exposure or environmental release resulting from opening the sealed containers and removing or washing out the PMN substancemayoccur only while the PMN- 23

-

**Hubst<tnc~** is in the 

### ro11scssion and control ofthe 

### Comp11ny or a person who h:t <: given the Company the written agreement rtXJuired by paragraph (b). (3) The sealed containers 

### must be labeled in accordance with paragraph 

### (b)(2) ofthe Hazard Communication Program section ofthis Order.


### (d)

**Hccipicnt_Non~Compliance.** 

### (1)

**It~** 

### at any

### time afier commencing distributionin commerce 

### ofthe P.MN substance, 

### 1'11e Company obtains knowledge that a recipient or transporter ofthe substance has failed to comply with any ofthe conditions spt:·cified 

### in paragraph (b) ofthis Distribution section or, after suhp:u·agraph 

### (b)(2) expires in accordance with subparagraph (e)(l), 

### has engaged in a significant
new use of the PMN substance (as defined in 40 CFR Part 721, SubpartE) without submitting a significant new use notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Companyis able to document each ofthe following: (a) That the Company has, within 5 working days , notified the recipient in writing that the



### rccipie~1t has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section, or has engaged in a significant new use ofthe l'MN substance without submitting significant new use notices to EPA. (b) That, within 15 working days ofnotit)rlltg the recipient ofthe noncompliance, the Companyreceived from the recipient, in writing, a statement ofassurance that the recipient is
aware ofthe tem1s ofparagraph (b) 

### ofthis Distribution 

### section and 

### will comply with those tenns,
or is aware ofthe terms 

### oftbe significantnew use rules for the 

### PMN substance and will not engage in significant new uses without submitting significant new use notices to EPA.- 24

- (c) If, after receiving a statement ofassurance from a recipient under subparagraph (d)(l)(b) ofthis Distribution section, the Company obtains knowledge that the recipient has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section, orhas engaged in a si!,rnificant new uses ofthe PMN substance without submitting a significant new usc notice to EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA ofthe failure to comply, and shall resume supplying thePMN substance to that recipient only upon written notification from the Agency. (2) If, at any time after commencing distribution in commerce ofthe PMN substance, EPA obtains knowledge (such as through a TSCA Section 11 inspection or subpoena), that a recipient ofthe substance has failed to comply with any ofthe conditions specified in paragraph (b) ofthe Distribution section or, after subparagraph (b)(2) expires in accordance with subparagraph (e)(l), has engaged in a significant new use ofthe PMN substance (as defmed in 40 CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, EPA may notify the Company inwriting**tha~,** despite the terms ofthis Order, EPA finds that the distribution in
commerce ofthe PMN substance will or may present an unreasonable risk ofinjury to human health or the environment. EPA's notice may specify that the Company unde1take certain actions concerning further testing, manufacture· , processing, distribution, usc and/or disposal ofthe PMN substanceto mitigate exposures to better characterize the risks presented by the PMN substance. Within 2 weeks from receipt ofsuch a notice, the Company must cease all manufacture, processing, distribution, use and disposal ofthe PMN substance, unless either: (a) within 2 weeks from receipt ofthe EPA notice, the Company complies with such requirements 

### as the notice specifies; or- 25

- (b) within 

### 4 weeks from receipt ofthe EPA notice, the Comp< my

**~ub.mits** to EPA a written report refuting EPA's finding and/or the appropriateness ofany additional actions imposed by EPA. The EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks ofreceipt ofEPA's wri tten response, the Company shall comply with any requirements imposed by EPA's notice orrevised response or, cease all manufacture, processing, distdbution, use and disposal ofthe PMN substance.
(e) Sunset Following SNUR. (1) Subparagraphs (b)(2) and (d)(2) ofthis Distribution section shall expire 75 days after promulgation ofa final SNLJRs for the PMN substance under section )(a)(2) ofTSCA, unless the Company is notified on or before that day ofan action inn Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, subparagraph (b)(2) aud (d)(2) ofthis Distribution section shall not expire until EPA notifies the Company in writing that aJI Federal Court actions involving the SNURhave been resolved and the validity ofthe SNUR 

### affirmed. (2) When EPA promulgates a flnal SNUR for the PMN substance and subparagraphs (b)(2) and (d)(2) ofthis Distribution section expires in accordance with subparagraph (e)(I), the Company sha ll notify each person to whom it distributes the PMN substance ofthe existence ofthe SNURs. Such notification must bein writing and must specifically include all limitations contained in the SNURs which arc defined as sjgnificantnew uses, and which would invoke significant new use notification to EPA for the PMN substance. Such notice must also reference the publication ofthe SNURs for this PMN substance in either the Federal Register orthe Code ofFcdcral Regulations. After promulgation of SNURs and expiration ofsubparahrraphs (b)(2) and (d)(2), such notices- 26

- may substitute for the written agreements required in the introductory clause ofparagraph (b); so that, ifthe Company provides such notices to the persons to whom 

### it distributes the PMN substance, then the Company is not requi red to obtain from such persons the written agreements specified inparagraph (b).

RELEASE TO WATER This provision does not supersede orpreempt any applicable federal, state, and local laws and regulations. (Those other laws may be more stringent than the requirements below
.) The Company is prohi bited from anypredictable orpurposeful release ofthe PMN substance, or any waste stream from manufacturing, processing, and use containing the PMN substance: (l)(a) Into the waters ofthe United States ifthe quotient from the formula: number ofkilograms/day /site released

---------------------------··---------- x 1000 = N parts perbillion receiving stream flow (million liters/day)
exceeds 4 parts per billion ("ppb"), when calculated using themethods described in 40 CFR 721.91. However, 40 CFR 721.9l(a)(4) does not apply. Instead, ifthe waste stream containing the PMN substance will be treated using biological treatment (activated sludge or equivalent) plus clarification, then the amount ofPMN substance reasonably likely to beremoved from the waste stream by such treatment maybe subtracted in q1lculating the number ofkilograms released. No
more than 90 percent removal efficiency may be attributed to such treatment. (b) In lieu ofcalculating the quotient in subparagraph (l)(a), monitoring or alternative calculations may beused to predict the surface water concentration expected to result from the intended release- 27

**~** ofthe .'Jubstancc, 

### ifthe monitoring

**proc(~dun'!S** or calr:ulations have been approved for such pnrpor;c by EPA. EPA will review and act on a written request to approve monitoring procedures or alternative calculations within 90 days after such a r(,'qUCSt isreceived. The Agency will infonn lhc Company ofthe disposition ofsuchrequests in writing and, where a request is denied, will explain the reasons theref ore.

Ill
. RECOR'DKF.EPING: (a)

**Recor:~~** The Company shall maintain the following records until 5 years after the date they
arc created and shall make them available for inspection and copying byEPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the PMN substance did in fact qualify for any
one or more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed by the Company. Any amounts orbatches ofthe PMN substance eligible for the export only exemption in Section I, Paragraph (b)(l) ofthis Order arc exempt fi'om all the requirements in this Recordkeeping section, 

### ifthe Company maintains, for 5 years from the date oftheir creation, copies ofthe export label and export notice to EPA, required byTSCA sections 12(a)(l)(B) and 12(b), respectively. Any amounts orbatches ofthe PMN substance eligible for the research and development exemption in Section I, Paragraph (b)(2) ofthis Order
are exempt from all the rcqujrements in this Rccordkeeping section, 

### ifthe Company maintains, for 5years from the date oftheir creation, the records required by40 CPR 720.78(b)
. .For any- 28

- amounts or batches ofthe PMN substance claimed to be eligible for any other exemption described in Section 

### I, Paragraph (b) ofthis 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 ofthe 

### PMN substance and the corresponding dates ofmanufacture; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture to whom the Company directly sells or transfers the PMN substance, the date ofeach sale or transfer, and the quantity ofthe substance sold or transfen-ed on such date; 

### ( 4) Records documenting the address of

### all sites ofmanufacture, processing, and use; (5) Records documenting establishment and implementation ofthe hazard communication program required by the Hazard Communication Program section ofthis Order; (6) Copies oflabels required under the Hazard Communication Program section ofthis Order; (7) Copies 

### ofMaterial Safety Data Sheets required by the Hazard Communication Program 

### section ofthis Order; (8) 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 ofthis Order;- 29
- (9) RGcords documenting compliance with any applicable

**dispos~l** requirements under the Disposal section ofthis Order, including method ofdisposal, location ofdisposal sites, dates of disposal, and volume ofPMN substance disposed. Wherethe estimated disposal volume is not known to the Company and is not reasonably ascertainable bythe Company, the Company must maintain otherrecords which demonstrate establishment and implementation ofa program U1at
ensures compliance with any applicable disposal requirements; (10) Records documenting establishment and implementation ofprocedures that ensure compliance with any applicable water discharge limitation in the Release to Watersection ofthis Order; ( 11) Copies ofany Transfer Documents and notices required bythe Successor Liability section ofthis Order, 

### ifapplicable; and, ( 12) The Company shallkeep a copy ofthis Order at each ofits sites where the PMN
substance is manufactured.

(b) Applicability. Theprovisions ofthis Recordkeeping Section are applicable onlyto activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Companys customers.
(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 

### 5 CFRPart 1320, particularly 

### 5 CFR 1320.5(b), the Company is notrequired to respond to this "collection of information" unless this Order displays a currently valid control number from the Office of- 3 0

- 

### Management and Budget ("OMB"), and EPA so informs the Company. The "collection of infonnation" required in this TSCA §5( e) Consent Order has been approved under currently va lid 

### OMB Control Number 2070-0012.
IV. REQUESTS FOR PRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CPR 720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyances associated with the PMN substance. To facilitate such inspections, EPApersonnel may contact the Company in advance to request information pertinent to the scheduling and conduct ofsuch inspections. Such requests may be written or oral. The types ofinformation that EPA may request include, but are not limited to, the following : (1) 

### Expected dates and times when the PMN substance will be in production within the subsequent 12 months; (2) Current workshift schedules for workers who are involved in activities associated with the PMN substance and mayreasonably be exposed to the PMN substance; (3) Currentjob titles or categories for workers who are involved in activities associated with the PMN substance and may reasonably be exposed to the PMN substance; (4) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substa nce and mayreasonably be exposed to the PMN substance; (5) Records required bythe Recordkeeping section ofthis Order; and/or, (6) Any other information reasonablyrelated to detennining compliance with this Order or conducting an inspection for that purpose.- 31

-
(b) 5;0JnP..!l.!1Y'.s Response. The Company shall respondto such requests within a reasonable period oftime, but in 110 event later than 30 days after receiving EPA's request. When requested in writing by EPA, the Company's response shallbe in writing. To the extent the information is known to orreasonably ascertainable by the Company at the time ofthe request, the Company's response shall demonstrate a good faith effort to providereasonably accurate and detailed answers to all ofEPA's requests. 

### (c)**~on.tidential** Business lnfotmation. Any Confidential 

### Business Information ("CBI") that the Company submits to EPA pursuant to paragraph (b) shall beprotected in accordance with §14 of TSCA and 40 CFR Part 2.



### V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) .S.9..ope. This section sets forth the procedures by which the Company's rights and obligations under this Ordermaybetransferred when the Company transfers its interests in the PMN substance, including the right to manufacture the PMN substance, to another person outside the Company (the "Successor 

### in Interest").
(b) Relation 

### ofTr!l!lsH"r Date 

### to Notice ofCommencement (''NOC,)
. (1) Before NOC
. Ifthe transfer from the Company to the Successorin Interest is effective before EPAreceives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN st1bstance from the Companypursuant to 40 CFR 720.102, the Successor in Interest must submit- 32

- 

### new PMN to EPA and comply fully with Section 5(a)(l) of TSCA and 40 CFR part 720 before commencing manufacture or import ofthe PMN substance. (2) After NOC. Ifthe 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 ofthis Order ;md shall not berequired to submit a new PMN to EPA.
(c) Definitions. The following definitions apply to this Successor Liability section ofthe Order: (1) "Successor in Interest" means a person outside the Company who has acquired the Company's full interest inthe rights to manufacture the PMN substance, including all ownership rights and legal liabilities, through transfer documents signed by the Company, as transferor, and the Successor in Interest, 

### as transferee. The tenn excludes persons who acquire less than the full interest ofthe Company in the PMN substance, such as a licensee who has acquired a limited license to the patent or manufacturing rights associated with the PMN substance. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordancewith 40 CFR 720.22(a)(3) and 40 CFR720.3(z). (2) "Transfer Document" means the legal instrument(s) used to convey the interests in the PMN substance, including theright to manufacture the PMN substance, from the Company to the Successor in Interest.


### (d) Notices. (1) Notice to Successor in Interest. On orbefore the effective date ofthe transfer, the Company shall provide to tlie Successor in Interest, by registered mail, a copy ofthe Consent- 33
- Order and the "Notice ofTrallSfcr" document which is incorporated by reference as Attachment B to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental
. Protection Agency, New Chemicals Management Branch (7405), 1200 PeJU1sylvania Avenue, 

### N.W., Washington, 

### D.C. 20460. (3) Jransfer Docutnent. Copies ofthe Transfer Document must be maintained by the Successorin Interest at its pr.incipal place ofbusiness, and at all sites where the PMN substance is manufactured. Copies ofthe Transfer Docmnent must also be made available for inspection pursuant to Section 

### J 1 ofTSCA, must state the effective date oftransfer, and must contain provisions which expressly transfer liability for the

### PMN substanceunder 

### the terms ofthis 

### Order from 

### the Company to the Successor in Interest.
(e) Liability. 

### (l) The Company shall be liable for compliance with the requirc1nents ofthis Order until the effective date ofthe transferdescribed above. (2) The Successor in Interest shall be liable for compliance with the requin:ments ofthis Order effective as ofthe date oftransfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, or omissions made, during the time in which the Company manufactured, processed, used, distributed in commerce, or disposed ofthe PMN substance pursuant to the tetms ofthis Consent Order.- 3.;

-- 35
- VI.

**M.QPJF~CA OON**  ANJ.U?.EVQ_!::A

**T(Q~** 

### OF

**_C{)j~T~}.!~**

### . 

## .T

**ORDJi:~** (a)

**Petition ~.**  (1) The Company may petition EPA at any time, based upon - new infom1at.ion on the environmental effects or environmental release ofthe PMN substance, to modifyorrevoke substantiveprovisions ofthis Order. (2) The exposures and risks identified byEPA during its review ofthe PMN substance and 

### the information 

### EPA determined to be necessruy to evaluate those exposures and risks arc described in the preamble to this Order. However, in determining whether to amend or

**revok~** this Order, EPA will consider all relevant infonnation available at the timethe Agency makes that determination, including, where appropriate, any rcns1 ;essment ofthe test data or other information that supports the findings in this Order, an examination ofnew test data or other information or analysis, and any other relevant information. (3) EPA 

### will issue a modification or.revocation 

### ifEPA determines that the activities proposed therein 

### will not present 

### an unreasonable risk ofinjury to health or the environment and will not result 

### in significant or substantial human exposure or substantial environmental release 

### in the absence ofdata sufficient to pennit a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. ( 4) In addition, the Company may petition EPA at any time to make other modifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent wit h the structure and intent ofthis Order as issued.- 36

- 

### (b) 

### Modification or.Revocationby

### EPA. Based on study' results describing in

### theparagraph (d) of the Testing Section or 

### ifEPA becomes aware ofinformation that the terms ofthe Consent Order
are notbeing adherecfto by

### downstrt'l8lll users as described inparagraph (d)(2) ofthe Distribution Section, EPA may

### mo. difyorrevoke this Consent Orderby

### following procedures set outinthese paragraphs.- 37
-
(a) Waiver. By consentin3 to the cnt1y ofthis Order, the Company waives its rights to file objections to this Order pursuant to section 5(e)(l)(C) of1'SCA, to receive service ofthis Orderno later than 45 days before the end ofthe review period pursuant to section 5(c){l)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to the facts or conch.1sions underlying the Agency's determinations in this proceeding. This waiver does not affect any other rights that the Company may haveunder TSCA.


### (b) 

### Q13.1 Bra9.kcts.!. By signing 

### this Order, the Companyrepresents that it

### has carefully reviewed this document and hereby agrees that all information herein that is claimed as confidential by the Company (per section 14 ofTSCA, 40 CFR 

### Patt 720 Subpart E, and 40 CFR Part 2) is correctly identified within brackets and that any information that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within the brackets. 

# JJ/ lo 

# I'L-l



# ~- j_ 

# V Date 

# JJevucJ_~-- Maria J. Do

# a:

**~D.** Director Chemical Control Division Office ofPollution Prevention and Toxics

### ATI'ACJIMENT A DEFINITIONS
Note: The attached Order maynot contain some of the terms defined below. "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed by the Chemical Abstracts Service'srules of nomenclature, or a name which will clearly identify a chemical substance for the purpose of conducting a hazard evaluation. "Company" means theperson orpersons subject to this Order. "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than byits chemical name. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical. Forpurposes ofthis section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, arc not considered to be containers. ''Contract Manufacturer" means a person, outside the Company, who is authorized to manufacture the PMN substance under the conditions specified in Part II. ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance. "Immediate use." A chemical substance is for the "immediate use" ofa person 

### ifit is under the control of, and used only by, the person who transferred it. fTOm 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 orimport into the customs territory ofthe United States. "Manuf acturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regard1ess ofphysica1 state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance.2 ".Non··industrial 

### useH means use other than 

### at a facility where 

### chemical substances 

### or mixtures are manufactured or processed. 

### "P
. MN substance" 

### means the chemical 

### substance described in the Prcmanufacture notice submitted by the Company relevant to this Order. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of processing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure 

### from the EPA-approved 

### protocol 

### or the Good Laboratory Practice 

### Standards at 40 CFR Part 792 without prior 

### or subsequent Agency approval 

### that prevents 

### a reasoned evaluation 

### ofthe health or environmental effects ofthe PMN substance. 

### "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-Rpproved protocols, are inconclusive, internally inconsistent, or otherwise 

### insufficient to permit a reasoned evaluation of the potential risk ofinjury to human health or the environment ofthe PMN substance. "Sealed container" 

### means a cJosed container that is 

### physically and chemically suitable for long-term containment ofthe P?vfN substance, and from which there will be no human exposure to, nor environmental release of, the l)MN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, t1ow, or disposal ofa chemical substance, regardless of

### physical state or concentration, through all intended operations of industtial, commercial, or consumer usc. "Waters ofthe United States" has the meaning set forth 

### in40 CFR 122.2. "Work area" means a room or defined 

### space in a workplace where the PMN substance is manufactured, processed, or used and where employees arepresent. "Workplace" means an establishment at one geographic location containing one or more work <rreas.

### Company (Transferor) ATI ACHMENT B NOTICE Of'TRk"fSFER 

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

PMNNumber
1. TransferofManuf.f!9ture**Rights~** 

### Effective on , the Company did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substance, which was the subject ofa premanufacturenotice ("PMN") and is governed by a Consent Order issued by the U.S. EnvironmentaJ Protection Agency ("EPA") under the authority of §5(e) of

### the Toxic Substances Control Act ("TSCA," 15 

### U.S.C. §2604(e)).
2. Assumption ofLiability. The Successor in Interesthereby cettifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the respons.ibility ofthe Successor in Interest. Successor in 

### Interest also 

### certifies that it is incorporated, licensed, or doingbusiness in the United States in accordance with 40 CFR 720.22(a)(3).


### 3
.**Confid~@i..~U?.JJ.siness** 

### lufonnation. The Successor in Interest hereby: reasserts.

_ relinquishes, or modifies all Confidentia l Business Information (''CBI") claims made bythe Company, pursuant to Section 14 ofTSCA and 40 CFR 

### part 2, for the PMN substance(s)
. Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer. Infonnation which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBI by the original submitter) would not subsequently be eligible for confidential treatment under this Notice ofTransfer.

### Company (Transferor) 2



### TOXIC SUBSTANCES CONTROL ACT SECfiONS(e) CONSENT ORDER NOTICE OFTRANSFER (continued) PMNNurnber
Signature ofAuthorized Official 

### Date
PrintedName ofAuthorized Official
Title ofAutho.rized Official



### Successor in

### Interest
Signature ofAuthorized Official 

### Date
Printed Name ofAuthorized Official
Title ofAuthorized Official Address 

### City, State, Zip Code3

TOXIC SUBSTANCES CONTROL ACT S
.

ECTION S(e) CONSENT ORDER NOTICE OFTRANS
. FER 

### (continued)

Successor's Technical Contact Address City, State, Zi p Code
Phone