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

In the matter of: ) Premanufacture NoticeNumber: ) ) ) ) )

. 

### ) P-12-548

) 

### ) ) ) )

Consent Order and Determinations Supporting Consent OrderTABLE OF CONTENTS
Preamble I. Introduction II. Summary ofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofExposure and Risk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health and Environmental Effects

Consent Order I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofinformation III. Recordkeeping IV. Requests for Pre-Inspection Information V. Successor LiabilityUpon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order
Attachment A

- Definitions
Attachment B -Notice ofTransfer ofConsent Order

## PREAMBLE

Under the authority of§ 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604( e)), the Environmental Protection Agency ("EPA" or "theAgency'') issues the attached Order, regardingpremanufacture notice ("PMN") P-12-548 for the chemical substance,-

PMN substance") submitted Company''), to take effect upon expiration ofthe PMNreview period. The Company submitted the PMN to EPA pursuantto § 5(a)(l) ofTSCA and 40 CPR Part 720. Under§ 15 ofTSCA, itis unlawful for any person to fail orrefuse to comply with any provision of§ 5 or any order issuedunder 

### § 5. Violators maybe subjectto various penalties and to both criminal and civil liabilitypursuant to § 16, and to specific enforcement and seizure pursuant to § 17. In addition, chemical substances subject to an Order issued under§ 5 ofTSCA, such as this one, are subject to the § 12(b) export notice requirement.



### II. SUMMARY OF TERMS OF THE ORDER The Consent Order for this PMN substance requires the Companyto: (a) submit to EPA certain toxicity testing before manufacturing or importing a total kilograms ofthe PMN substance; (b) submit to EPA any data developed to comply with REACH (Regulation, Evaluation, ./tuthorization, ru'ld Res1Tiction ofChemicals in the European Union); (c) provide personal protective equ.ipr.n_ent to its workers to prevent dermal exposure;(d) label containers ofthePMN substance and provide Material SafetyData Sheets ("MSDSs") andworker training in accordance with the provisions ofthe Hazard Communication Program section; (e) not manufacture, process, or use the PMN substance other than as
(f) distribute the PMN substance onlyto a person who agrees to follow the same restrictions (except the testing requirements); (g) maintain certain records.

III. CONTENTS OF PMN By signing this Order, the Company represents that ithas carefullyreviewed this document and agrees that all information herein that is claimed as confidential bythe Company is correctly identified within brackets and that anyinformation that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove onlythe information contained within the brackets. Confidential Business Information Claims (Bracketed in the Preamble and Order): Company Name, Chemical Identity, Production Volume, Use, and Manufacturing and Processing Information. Chemical Identity:

Generic: Aryl-substituted alkane
Specific: Generic: Dielectric Fluid.Test Data Submitted with PMN: Bacterial gene mutation assay (Ames)- Negative. Chromosomal aberration test- Negative. Rat inhalation LC50 > 1mg/L but <5 mg/L; Skin sensitization in the mouse local lymph node assay (up to 25% active ingredient)- Negative. Rat 28-day oral study (analogue) No Observed Effect Level (NOEL)= 50 mg/kg, livertoxicity at**~250mg/kg;** Rat 28-day oral study (analogue) NOEL= 15 mg/kg, livertoxicity at**~150** mglkg; rat oral combined protocol (OECD 422) NOEL= 30 mg/kg (parental animals), livertoxicity at higher doses; reproductive toxicity NOEL= I00 mg/kg (highest dose tested); developmental toxicityNOEL= 10 mg/kg.



### IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK The following are EPA's predictions regarding the probable human and environmental toxicity, human exposure and environmental release ofthe PMN substance, based on the information currently available to the Agency.
Persistent, Bioaccumulative, and Toxic Concern: EPA identified human health and environmental concerns because the PMN substance maybe a persistent, bioaccumulative, and toxic (PBT) chemical, based on physical/chemical properties of the PJVIN substance, as described in the New Chemicals.Program's PBT category (64 FR 60194, November 4, 1999)(FRL-6097-7). EPA estimates that the PMN substance will persist in theenvironment for more than two months and estimates a bioaccumulation factor ofgreater than or equal to 1,000.

Human Health Effects Summary: Absorption: The PMN substance is expected to be absorbed dermally and byinhalation. Toxicological Endpoints ofConcern: Developmental toxicity and livertoxicity. Basis: Submitted test data.

Environmental Effects Summary: Based on EcoSAR analysis for neutral organic chemicals the PMN substance maybetoxic to aquatic organisms at concentrations as low as 8 ppb. See www.epa.gov/opptintr/newcherns/pubs/chemcat.htrn
Exposure and Environmental Release Summary: Manufacture Use #Sites Workers Exposure
880 880
Inhalation Exposure 0.027 0.017

# IDrinking

### Wate~ none <lmg/yr

none < 1 ppb Concentration Days Exceeding none none Concern Level
Risk to Workers: There is a potential risk to workers from dermal exposure to the PMN substance
as these potential exposures result in a margin ofexposure ofonly 33 from theNOEL of30 mg!kg/day. Risk to General Public and the Environment: Because the PMN substance maybe a PBT substance with both human health and environmental effects, potential releases ofthe PMN substance may result in risks to the environment and general public.



### V. EPA'S CONCLUSIONS OF LAW The following findings constitute thebasis ofthe Consent Order: (a) EPA is tmable to deter-mine the potential for effects from exposure ofhumans and aquatic organisms to the PMN substance. EPA therefore concludes, pursuant to§ 5(e)(l)(A)(i) ofTSCA, that L\e inf.•mnation available to the Agency is insufficient to permit a reasoned evaluation ofthe human health and environ1nental effects ofthe P}.;IN substance.(b) In light ofthe potential risk to human health and the environment posed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, EPA has concluded, pursuant to § 5(e)(l)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance maypresent an unreasonable risk ofinjury to human health and the environment.

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND ENVIRONMENTAL EFFECTS triggered Testing. The Orderprohlbits 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.

## CONSENT ORDER

I. SCOPE OFAPPLICABILITY AND EXEMPTIONS (a) Scope. The requirements ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe chemical sulJst:m<:e
(P-12-548 )("the PMN substance") in the United States ("the Company''), except to the extent that those activities are exempted byparagraph (b).
(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance is exempt from the requirements ofthis Order (except the requirements in the Recordkeeping and Successor LiabilityUpon Transfer OfConsent 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 compliance is documented by appropriate recordkeeping as required in the Recordkeeping section ofthis Order.
(I) Export. Until the Companybegins commercial manufacture ofthe PMN substance for
use in the United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe PMN substance solely for export in accordance with TSCA §§12(a) and 12(b), 40 CFR 720.3(s) and 40 CFRPart 707. However, once the Companybegins to manufacture the PMN substance for use in the United States, no further activitybythe Company involving the PMN substance is exempt as "solely for export" even ifsome amount ofthe PMN-2- substance is later exported. At that point, the requirements ofthis Order apply to all activities associated with the PMN substance while inthe territory ofthe United States. Prior to leaving U.S. territory, even those quantities orbatches ofthe PMN substance that are destined for export
are subject to tenus ofthe Order, and count towards anyproduction volume testtriggers in the Testing section ofthis Order. (2) Research & 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 research and development in accordance with TSCA §5(h)(3), 40 CPR 720.3(cc), and 40 CPR 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.CPR 720.30(i). (3) Bvvroducts. The requirements ofthis Order do not apply to the PMN substance when itis produced, withoutseparate commercial intent, only as a "byproduct" as defined at 40 CPR 720.3(d) and in compliance with 40 CPR 720.30(g). (4) No Separate Commercial Pumose. The requirements ofthis Order do not apply to the PMN substance when it is manufactured, pursuant to any ofthe exemptions in40 CPR 720.30(h), with no commercial purpose separate from the substance, mixture, or article ofwhich it is a part. (5) Imported Articles. Therequirements ofthis Order do not apply to the PMN substance when it is imported as part ofan "article" as defined at 40 CPR 720.3(c) and in compliance with 40 CPR 720.22(b)(l).
(c) Automatic Sunset. Ifthe Company has obtained forthePMN substance a Test Market Exemption ("TME") under TSCA §5(h)(l) and 40 CPR 720.38 or a Low Volume Exemption- 3 - ("L VE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)( 4) and 40 CFR 723.50(c)(l) and (2) respectively, any such exemption is automatically rendered null and void as ofthe effective date ofthis Consent Order.

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION
PROHffiiTION The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe PMN substance in the United States, for anynonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substance, and the completion 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 substantial risk ofinjuryto health or the environment and which is required to bereported 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.-4- (b) Notice ofStudy Scheduling. The Company shall notifY, in writing, the EPA Monitoring Assistance and Media Programs Division (2227A), 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 required to beperformed pursuant to this Order, or within 15 days after the effective date ofthis Order, whichever is later: (1) The date when the studyis scheduled to commence; (2) The name and address ofthe laboratory which will conduct the study; (3) The name and telephone number ofa person at the Company orthe laboratory whom EPA may contact regarding the study; and, ( 4) The appropriate PMN identification number for each substance and a statement that the substance is subject to this Consent Order.
(c) ·Good Laboratory Practice Standards and Test Protocols. Each studyperformed to address the risks identified in this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CPR Part 792 and usingmethodologies generally accepted in the relevant scientific community at the time the studyis initiated. Before starting to conduct any studythat will use a modified version ofa published test guideline, the Companymust submit written test protocols to EPA for review (submission ofwritten test protocols is optional for tests that are to be conducted using unmodified published test guidelines). Protocols mustbe submitted as a support document for the PMN, using the procedures set out in 40 CPR 720.40. EPA will respond to the Company within 4 weeks ofreceiving the written protocols. EPA review ofa test protocol does not mean pre-acceptance oftest results.- 5-

(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or importing the PMN substancebeyond the following aggregate production volumes ("the production limits"), unless the Company conducts the following studies onthe PMN substance and submits all final reports and underlying data in accordance with the conditions specified in this Testing section.

a 14-day dermal toxicity test

a bioaccumulation in sedimentdwelling benthic oligochaetes test
a sediment and soil adsorption/ desorption mobilityin soils Production Limit Test Guideline (OPPTS 870.3200 or OECD 410) (OECD 315) (OPPTS 835.1220) (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 final report ofeach study (with an additional sanitized copy, if confidential business information is involved) and all underlying data ("the report and data") to EPA, prior to exceeding the applicable production limit. The final report and data mustbe submitted as a support document for the PMN, using the procedures set out in40 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 tomean "shall" to make clear that the submission ofsuch information is mandatory. EPA will require the submission ofraw

### -6- data such as slides and laboratory notebooks onlyifEP A finds, on the basis ofprofessional judgment, that an adequate evaluation ofthe study cannot take place inthe absence ofthese ite111s.
(f) Testing Waivers. The Companyis not required to conducta study specified inparagraph (d) of this Testing section ifnotified in writing byEPA that it is unnecessary to conduct that study.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Companymay continue to manufacture and import the PMN substance beyond the applicable production limit. To seek relieffrom any otherrestrictions ofthis Order, the Company maymake
a second attempt to obtain unequivocal databyreconducting the studyunder the conditions specified in paragraphs (b), (c), and (e) (except that the·stu4y maybe submitted after reaching the applicable production limit)
..The testing requirements maybe modified, as necessaryto permit a reasoned evaluation ofthe risks presented bythe PMN substance, onlyby mutual consent ofEPA and the Company.
(h) EPA Determination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA'sreceipt ofa test report and data, the Companyreceives written notice that EPA fmds that the data generated by
a study are scientifically invalid, the Companyis prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Companymay continue to manufacture and import the PMN substance beyond the applicable production limit only ifso notified, in writing, byEPA inresponse to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii).- 7- (i) Ifthere is sufficienttime to reconduct the study in compliance with paragraphs (b), (c), and (e) before exceeding the production limit specified inparagraph (d), the Company mayreconduct the study. Ifthere is insufficient time to reconduct the study in compliance with paragraphs (b), (c), and (e) before exceeding the production limit specified in paragraph (d), the Companymay exceed the producticm limit, but must otherwise comply with paragraphs (b), (c), and (e), and shall submit the report and data to EPA within a reasonableperiod oftime, all as specified byEPA in the notice described in subparagraph (h)(!}. EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data. (ii) The Companymay, within 4 weeks ofreceiving from EPA the notice described in subparagraph (h)(!), submit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.
(i) Company Determination ofInvalid Data. (1) Except as described in subparagraph (i)(2), ifthe Companybecomes aware that circumstances clearlybeyond the control ofthe Company or laboratory will prevent, orhave prevented, development ofscientificallyvalid dataunder the conditions specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Company may submit to EPA, within 2 weeks offrrst becoming ay.'are ofsuch circumstances, a written statement explaining why circumstances clearlybeyond the control ofthe Company or laboratory will cause orhave caused development ofscientifically invalid data. EPA will notifY the Company ofits response, in writing, within 4 weeks ofreceiving the.Company's report. EPA's written response may either:

### - 8 - (i) allow the Company to continue to manufacture and import the PMN substance beyond the applicable production limit, or (ii) require the Company to continue to conduct, or to reconduct, the study in compliance with paragraphs (b), (c), and (e), ifthere is sufficient time to conduct or reconduct the study and submit the report and data to EPA before exceeding the production limit specified in paragraph (d). Ifthere is insufficient time for the Companyto complywith paragraphs (b), (c), and (e) before exceeding the production limit specified inparagraph (d), the Companymay 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 Companymay continue to manufacture and import beyond the applicable production limit.
G) Unreasonable Risk. EPA may notify the Company in writing that EPA finds that the data generated by a study
are scientificallyvalid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substance will ormay present an unreasonable risk ofinjuryto human health or the enviromuent. EPA's notice may specify that the Companyundertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthePMN substance to mitigate exposures to or to better characterize the risks presentedbythe PMN substance. Within 2 weeks from receipt ofsuch a notice, the Companymust cease all manufacture, import, processing, distribution, use and disposalofthe EMN substance, unless either:-9- (1) within 2 weeks from receipt 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 imposedbyEPA. The Company may continue to manufacture, import, process, distribute, use and dispose ofthe PMN substance in accordance with the terms ofthis Orderpending 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 complywith any requirements imposed byEPA's response or cease all manufacture; import, processing, distribution, use and disposal ofthe PMN substance.
(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Companymust continue to obey all the t=s ofthis Consent Order until otherwise notified in writing by EPA. The Companymay, based upon submitted test data or other relevant information, petition EPA to modify orrevoke provisions ofthis Consent Order pursuant to Part VI. ofthis Consent Order.
(l) The Companyis required to submit all final reports and the underlying data ofany testing developed to comply with REACH (Regulation, Evaluation, Authorization, and Restriction of Chemicals in the European Union) no later than 90 days after submission ofthe testing to the European Uuion.- 10- 

### PROTECTION IN THE 

### WORKPLACE (a) Establishment ofProgram. During manufacturing, processing, and use ofthe PMN substance at any site controlled bythe Company (including any associated packaging and storage and during any cleaning or maintenance ofequipment associated with the PMN substance), the Company must establish a program whereby: (1) General Dermal Protection. Each person who is reasonably likely to be dermally exposed in the work area to the PMN substance through direct handling ofthe substance or through contact with equipment on which the substance may exist, is provided with, and is required to wear, personal protective equipment thatprovides a barrier to prevent dermal exposure to the substance in the specific work area where it is selected for use. Each such item ofpersonal protective equipment mustbe selected and used in accordance with Occupational Safety and Health Administration ("OSHA") dermal protection requirements at 29 CPR 1910.132, 1910.133, and 1910.138. (2) Specific Dermal Protective Equipment. The dermal protective equipment required by subparagraph (a)(l) ofthis section must include, butis not limited to, the following item: Gloves. (3) Demonstration ofImperviousness. The Company is able to demonstrate that each item ofchemical protective clothing selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within the work areaby any one or a combination ofthe following: (i) Permeation Testing. Testing the material used to make the chemical protective clothing.and the construction ofthe clothing to establish thattheprotective
..clothing will be impervious for the expected duration and conditions ofexposure. The testing must subject the- 11 - chemical protective clothing to the expected conditions ofexposure, including the likely combinations ofchemical substances to which the clothing maybe exposed in the work area. Permeation testing shall be conducted according to the American Society for Testing and Materials ("ASTM") F739 "StandardTest Method for Permeation ofLiquids and Gases through Protective Clothing Materials under Conditions ofContinuous Contact." Results shall bereported as the cumulative permeation rate as a function oftime, and shall be documented in accordance with ASTM F739 using the format specified in ASTM F1194-99(2010) "Standard Guide for Documenting the Results ofChemical Permeation Testing ofMaterials Used in Protective Clothing Materials." 'Gloves may notbeused for a time period longer thanthey are actually tested and must be replaced at the end ofeach work shift during which they are exposed to the PMN substance. (ii) Manufacturer's Specifications. Evaluating the specifications from the manufacturer or supplier ofthe chemical protective clothing, or ofthe material used in construction ofthe clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likely combination with other chemical substances in the work
area.

HAZARD COMMUNICATIONPROGRAM (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 communication program available, upon request, to all employees, contractor employees, and their- 12- designated representatives. The Companymayrely on an existing hazard communication program, including an existing program established under the OSHA Hazard Communication Standard (29 CFR 1910.1200), to complywith this paragraph provided that the existing hazard communication program satisfies the requirements ofthis section. The written program shall include the following: (1) A list ofchemical substances known to bepresent in the work area which are subject to
a TSCA section S(e) consent order signed bythe Company or to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E. The list must be maintained in each work areawhere the PMN substance is known to bepresent andmustuse the identityprovided on the MSDS for the substance required under paragraph (c) ofthis sectimi. The list maybe compiled for the workplace
or for individual work areas. Ifthe Company is required eitherby another Order issued under section S(e) ofTSCA, orby a TSCA section 5(a)(2) SNUR at 40 CFRPart 721, subpart E, to maintain a list ofsubstances, 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 their work 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 likelyto be exposed to the PMN

substance while in the Company's workplace.
(b) Labeling.- 13- (1) The Company shall ensure that each container ofthe substance in the workplace is labeled in accordance with this subparagraph (b)(1). (i) The label shall, at a minimum, contain the following information: (A) A statement ofthe health hazards(s) and precautionarymeasure(s), if any, identified either inparagraph (f) ofthis section orbythe Company, for the PMN substance. (B) The identityby which the PMN substance may be commonly recognized. (C) A statement ofthe enviromnental hazard(s) and precautionary measure(s), ifany, identified eitherin paragraph (f) ofthis section, orbythe Company, for the

. PMN substance. (D) A statement ofexposure and precautionarymeasure(s), ifany,

identified either in paragraph (f) ofthis section, orby the Company, for the PMN substance. (ii) The Company mayuse signs, placards, process sheets, batch tickets, operating procedures, or other such written materials in lieu ofaffixing labels to individual stationaryprocess containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by subparagraph (b)(1)(i) ofthis section. Any written materials must bereadily 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 transfer. (iv) The Company shall not remove or deface an existing label on containers ofthe

.BMN substance obtained from persons outside the Companyunless the container is immediately re-labeled with the information specified in subparagraph (b)(I)(i) ofthis section.- 14- (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 information: (A) The information prescribed in subparagraph (b)(I)(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 emergencyprocedures. (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 bythe Department ofTransportation. (3) The label, or alternative forms ofwarning, shall be legible and prominently displayed. (4) The label, or alternative forms ofwarning, shall be printed in English; however, the information mayberepeated in other languages. (5) Ifthe label or alternative form ofwarning is to beapplied to a mixture containing the PMN substance in combination with any othersubstance that is either subject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, or defmed as a "hazardous chemical" under the OSHA Hazard Communication Standard (29 CFR 1900.1200), the Companymayprescribe onthe label, MSDS, or·a]ternative form ofwarning, the measures to control worker exposure or environmental release which the Company determines provide the greatest degree ofprotection. However, should these control measures differ from the applicable measures required under this Order, the Companymust seek'a determination ofequivalency for such alternative controlmeasurespursuantto 40 CFR 721.30 beforeprescribing them under this subparagraph (b)(5).- 15

- (6) 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 label within 3 months from the time the Companybecomes aware ofthe new information. Ifthe PMN substance is not being manufactured, imported, processed, orused in the Company's workplace, the Companymust add the new information to the label before the PMN substance is reintroduced into the workplace.
(c) Material Safety Data Sheets. (1) The Companymust obtain or develop an MSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) Theidentity used on the container label ofthe PMN substance underthis section, and, ifnot claimed confidential, the chemical and common name ofthePMN substance. Ifthe chemical and common nartles are claimed confidential, a generic chemical name mustbe used. (ii) Physical and chemical characteristics ofthe substance known to the Company, (e.g., vapor pressure, flash point). (iii) The physical hazards ofthe substance known to the Company, including the potential for fire, explosion, and reactivity. (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 aggravatedbyexposure to the PMN substance known to the Company. (vi) Theprimary routes ofexposure to the PMN substance.

### - 16- (vii) Precautionary measures to control worker exposure and/or environmental release required bythis Order, or alternative control measures which EPA has determined under 40 CFR 721.30 provide substantiallythe 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 Compa:hy, including appropriate hygienic practices, protective measures during repair and maintenance ofcontaminated equipment, and procedures for response to spills and leaks. (ix) Any generally applicable control measures which are known to the Company, such as appropriate engineering controls, workpractices, 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 partywho can provide additional information on the chemical substance and any appropriate emergencyprocedures. (3) Ifno relevant information is found orknown for any given category on the MSDS, the Companymust mark the MSDS to indicate that no applicable information was found. ( 4) Wheremultiple mixtures containing the PMN substance have similar compositions (i.e., the chemical ingredients are essentially the same, butthe specific composition varies from mixture to mixture) and similarhazards, the Companymayprepare one MSDS to apply to all of these multiple mixtures. (5) Ifthe Companybecomes aware ofany significant new information regarding the hazards ofthe PMN substance or ways.toprotecLagainsUhe hazards, this new information mustbe added to the MSDS within 3 months from the time the Companybecomes aware ofthe new- 17- information. Ifthe PMN substance is not beingmanufactured, imported, processed, orused inthe Company's workplace, the Companymust add the new information to the MSDS before the PMN substance is reintroduced into the workplace. (6) The Companymust 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 Companymay eitherprovide the MSDS with the shipped containers or send itto the person prior to or at thetime ofshipment. (7) The Companymust 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) The MSDS maybe kept in any form, including as operating procedures, and maybe designed to cover groups ofsubstances in a work area where it maybemore appropriate to address the potential hazards ofa process rather than individual substances. However, in all cases, the required information must beprovided for the PMN substance and must be readily accessible during each work shift to employees when they are in their work areas. (9) The MSDS mustbeprinted in English; however, the information mayberepeated in other languages.
(d) Employee Information and Training. The Companymust ensure that employees are provided with information and training onthe PMN substance. This information and training mustbe provided at the time ofeach employee's initial assignment to a work area containing the PMN substance and wheneverthe PMN substance is introduced into the employee's work area for the

·firsUirne•. (I) The information provided to employees under this paragraph shall include:- 18- (i) The requirements ofthis section. (ii) Any operations in the work area where the PMN substance is present. (iii) The location and availability ofthe written hazard communication program required under paragraph (a) ofthis section, including the list ofsubstances required by subparagraph (a)(l) ofthis section and MSDSsrequired byparagraph (c) ofthis section. (2) The training provided to employees shall include: (i) Methods and observations that maybeused to detect the presence orrelease of the PMN substance in or from an employee's work area (such as exposure monitoring conducted bythe Company, continuous monitoring devices, visual appearance, or odor ofthe substance when beingreleased). (ii) Thepotential human health and environmental hazards ofthe PMN substance
as specified inparagraph (f) ofthis section. (iii) The measures employees can take to protect themselves and the environment from the PMN substance, including specific procedures the Companyhas implemented to protect employees and the environment from exposure to the PMN substance, including appropriate work practices, emergencyprocedures, 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) The requirements ofthe hazard communication program developed bythe Companyunder this section, including an explanation ofthe labeling system and the MSDS requiredby.this section and guidance on obtaining and using appropriate hazardinformation
..- 19- (e) De Minimis Concentrations. Therequirements ofthis Hazard Communication section do not applyto 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 percentby 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 has reason to believe that, during intended activities, the PMN substance in the mixture maybe reconcentrated above the 1.0 or 0.1 percent level, whichever applies. Ifthis Order contains (l) New Chemical Exposure Limits provisions that specifY a NCEL concentration less than the de minimis concentration specified here, or (2) Release to Waterprovisions that prohibit release to water or specifY in-stream concentration ("N") less than the de minimis concentration specified here, then this de minimis exemption does not apply to those provisions.
(f) Human Health, Environmental 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 specified in paragraph (c) ofthis section: (1) Human health hazard statements. This substance may cause: (i) internal organ effects. (ii) developmental effects. (2) Human hazard precautionary statements. When using this substance: (i) avoid skin contact. (ii) use skin protection. (3) Environmental hazard statements., This substance maybe: (i) toxic to aquatic organisms.

### -20- (4) The human and environmental hazard and precautionary statement on the label prepared pursuant to paragraph (b) ofthis section must be followed bythe statement: "See the MSDS for details." (g) Existing Hazard Communication Program. The Companyneed not take additional actions if existing programs and procedures satisfy the requirements ofthis section.

MANUFACTURING (a)(!) Prohibition. The Company shall not cause, encourage, or suggest the manufacture orimport ofthe PMN substance by any otherperson. (2) Sunset Following SNUR. Subparagraph (a)(!) shall expire 75 days after promulgation ofa final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) ofTSCA unless the Company is notified on orbefore 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 Company in writing that all Federal Court actions involving the SNUR have been resolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. WhenEPApromulgates a final SNUR for the PMN substance and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each person whom it causes, encourages or suggests to manufacture orimport the PMN substance ofthe existence ofthe SNUR.
(b) The Company shall not manufacture, process, or use the PMN substance otherthan as a- 21

- DISTRIBUTION (a) ExportNotice Requirement. No later than the date ofdistribution, the Company shall notify in writing anyperson to whom it distributes the PMN substance that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section 12(b) and 40 CPR 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 ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity.
(b) Distribution Requirements. Except as provided inparagraph (c), the Company shall distribute the PMN substance outside the Company, otherthan for disposal, onlyto a person who has agreed in writing prior to the date ofdistribution, to: (1) Notify in writing anyperson to whom it distributes the PMN substance that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section 12(b) and 40 CPR 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 ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Comply with the same requirements and restrictions, ifany, required ofthe Company in the Protection in the Workplace section ofthis Order. (3) Complywith the same requirements and restrictions, ifany, required ofthe Company

..in the Hazard Communication Program section ofthis Order. ( 4) Not further distribute the PMN substance to any otherperson, other than for disposal.-22-

(5) Notprocess oruse the PMN substance: otherthan 

### as

(c) Temporary Transport and Storage. Notwithstandingparagraph (b), the Companymay distribute the PMN substance outside the Company for temporary transport and storage in sealed containers provided the following three conditions are met: (1) Subsequent to any such exempt temporary transport or storage ofsealed containers, the PMN substance maybe distributed only to the Company or a person who has given the Company the written agreement required byparagraph (b). (2) Any human exposure or environmental release resulting from opening the sealed containers and removing or washing out the PMN substancemay occur onlywhile the PMN substance is inthe possession and control ofthe Company or a person who has given the Company the written agreement required byparagraph (b). (3) The sealed containers mustbe labeled in accordance with paragraph (b)(2) ofthe Hazard Communication Program section ofthis Order.
(d) Recipient Non-Compliance. If, at any time after commencing distribution in commerce ofthe PMN substance, the Company obtains knowledge that a recipient ofthe substance has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section or, after subparagraph (b)(2) expires in accordance with subparagraph (e)(l), has engaged in a significant
new use ofthe PMNsubstance 

### (as defmed in 40 CPR Part 721, Subpart E) without subniitting.a significant new use notice to EPA, the Company shall cease supplying ii'le substance to that

### -23- recipient, unless the Company is able to document each ofthe following: (I) That the Companyhas, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe conditions specified inparagraph (b) ofthis Distribution section, orhas engagedin a significant new use ofthe PMN substance without submitting a significantnew use notice to EPA. (2) That, within 15 working days ofnotifying the recipient ofthe noncompliance, the Company received from the recipient, in writing, a statement ofassurance that the recipient is
aware ofthe terms ofparagraph (b) ofthis Distribution section and will comply with those terms,
or is aware ofthe terms ofthe significant new userule for the PMN substance and will not engage in a significant new use without submitting a significant new use notice to EPA. (3) If, after receiving a statement ofassurance from a recipient under subparagraph (d)(2) ofthis Distribution section, the Company obtains knowledge that the recipient has failed to comply with any ofthe conditions specified inparagraph (b) ofthis Distribution section, orhas engaged in
a significant new use ofthe PMN substance without submitting a significant new use notice to EPA, the Company shall cease supplying the PMN substance to that recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN substance to that recipient onlyupon written notification from the Agency.
(e) Sunset Following SNUR. (!) Subparagraph (b)(2) ofthis Distribution section shall expire 75 days after promulgation ofa final SNUR for the PMN substance under section 5(a)(2) ofTSCA, unless the Company is notified on or before that day ofan action in a Federal Court seeking judicial review ofthe SNUR. Ifthe Cmnpanyjs.so.notified, subparagraph (b)(2) ofthis Distribution section shall not expire until EPA notifies the Companyin writing that all Federal-24- Court actions involving the SNUR havebeen resolved and the validity ofthe SNUR affirmed. (2) When EPA promulgates a fmal SNUR for the PMN substance and subparagraph (b)(2) ofthis Distribution section expires in accordance with subparagraph (e)(l), the Company shall notify each person to whom it distributes the PMN substance ofthe existence ofthe SNUR. Such notification must bein writing and must specificallyinclude all limitations contained in the SNUR which are defined as significant new uses, and which would invoke significant new use notification to EPA for the PMN substance. Such notice must also reference the publication ofthe SNUR for this PMN substance in either the Federal Register orthe Code ofFederal Regulations. After promulgation ofa SNUR and expiration ofsubparagraph (b)(2), such notice may substitute for the written agreement required in the introductory clause ofparagraph (b); so that, ifthe Company provides such notice to the persons to whom it distributes the PMN substance, then the Company is notrequired to obtain from such persons the written agreement specified in paragraph (b).

III. RECORDKEEPING (a) Records. The Company shall maintain the following records until 5 years after the date they
are created and shall make them available for inspection and copyingbyEPA 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 bythe Company. Any amounts or batches ofthe PMN substance eligiblefor the export only exemption in Section I, Paragraph (b)(l).ofthis Order are exempt from all the requirements in this Recordkeeping section, ifthe Companymaintains, for 5 years from the-25- 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 requirements in this Recordkeeping section, ifthe Companymaintains, for 5 years from the date oftheir creation, the records required by40 CFR 720.78(b). For any amounts orbatches 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 inparagraphs (2) and (3) below, but is exempt from the otherrecordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume ofthe PMN substance and the corresponding dates ofmanufacture and import; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture orimport to whom the Company directly sells ortransfers the PMN substance, the date ofeach sale ortransfer, and the quantity of the substance sold ortransferred on such date; ( 4) Records documenting the address ofall sites ofmanufacture, import, processing, and use; (5) Records documenting establishment and implementation ofa program for the use of any applicable personal protective equipment required pursuant to the Protection in the Workplace section ofthis Order; (6) Records documenting the determinations required bythe Protection in the Workplace section ofthis Orderthat chemical protective clothing is impervious to the PMN.·substance;

### -26- (7) Records documenting establishment and implementation ofthe hazard communication program required bythe Hazard Communication Program section ofthis Order; (8) Copies oflabels required under the Hazard Communication Program section ofthis Order; (9) Copies ofMaterial Safety Data Sheets required by the Hazard Communication Program section ofthis Order; (10) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, Use, and Distribution sections ofthis Order, including distributees' written agreement to comply with the Distribution section of this Order; (11) Copies ofany Transfer Documents and notices required bythe Successor Liability section ofthis Order, ifapplicable; and, (12) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substance is manufactured orimported.
(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Company's customers.
(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CPR Part 1320, particularly 5 CPR 1320.5(b), the Company 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 Company. The "collection of-27- information" required in this TSCA §5(e) Consent Orderhas been approved under currently valid OMB ControlNumber 2070-0012.



### IV. REQUESTS FOR PRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to sectionII ofTSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyances associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the Company in advance to request information pertinent to the scheduling and conduct ofsuch inspections. Such requests maybe written or oral. The types ofinformation that EPA mayrequest include, but are not limited to, the following: (I) 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 mayreasonablybe exposed to the PMN substance; (3) Currentjob titles or categories for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; ( 4) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; (5) Records required bythe Recordkeeping section ofthis Order; and/or, (6) Any other information reasonably related to determining compliance with this Order or conducting an inspection for that purpose.-28- (b) Company's Response. The Company shall respond to such requests withln a reasonable period oftime, but in no event laterthan 30 days after receiving EPA's request. When requested in writing byEPA, the Company's response shall be in writing. To the extent the information is known to orreasonably ascertainablebythe Company at the time ofthe request, the Company's response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests.
(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with §14 of TSCA and 40 CFR Part 2.

V. SUCCESSORLIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures bywhich 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 anotherperson outside the Company (the "Successor in Interest").
(b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (1) BeforeNOC. Ifthe transfer from the Company to the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN substance from the Companypursuant to 40 CFR 720.102, the Successor in Interest must submit a
new PMN to EPA and comply fully with Section 5(a)(1) ofTSCA.and4G CFRpart 720 before commencing manufacture or import ofthe PMN substance.-29- (2) AfterNOC. 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 and shall notberequired 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 in the rights to manufacture the PMN substance, including all ownership rights and legal liabilities, through a transfer document signed bythe Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Companyin the PMN substance, such as a licensee who has acquired a limited license to the patent ormanufacturing rights associated with the PMN substance. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(a)(3) and 40 CFR 720.3(z). (2) "Transfer Document" means the legal instrument(s) used to conveythe interests inthe PMN substance, including the right to manufacture the PMN substance, from the Companyto the Successor in Interest.
(d) Notices. (1) Notice to Successor in Interest. On or before the effective date ofthe transfer, the Company shall provide to the Successor in Interest, byregistered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated byreference as Attachment B to this Order. ' · · ·- 30- (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 PennsylvaniaAvenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document mustbe maintainedbythe Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substance is manufactured or imported. Copies ofthe Transfer Document must also be made available for inspectionpursuant to Section 11 ofTSCA, must state the effective date oftransfer, aiJ.d must contain provisions which expressly transfer liability for the PMN substance under the terms ofthis Order from the Companyto the Successorin Interest.
(e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective .date ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date oftransfer. (3) Nothing inthis section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, or omissions made, during the time in which the Companymanufactured, processed, used, distributed in commerce, or disposed ofthe PMN substance pursuant to the terms ofthis Consent Order.
(f) Obligations to Submit Test Dataunder Cons.ent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Order requires the Companyto submit test data to EPA at a specified production- 31

- volume ("test trigger"), the aggregatevolume ofthe PMN substance manufactured and imported bythe Companyup to the date oftransfer shall count towards the test trigger applicable to the Successor in Interest.

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company maypetition EPA at anytime, based upon new information on the human health or environm,ental effects of, or human exposure to or environmental release of, the PMN substance, to modify orrevoke substantive provisions ofthis Order. The exposures and risks identified byEPA during its review ofthe PMN substance and the information EPA determined to be necessaryto evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available at the time the Agencymakes that determination, including, where :1ppropriate, anyreassessment 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 otherrelevant information. EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will not present an unreasonable risk ofinjuryto health orthe environment and will not result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects of the PMN substance. In addition, the Company maypetition EPA at anytime to make other modifications to the languageofthis Order. EPA will issue such a modificationifEP A.determines that the-32- modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.-33- VII. EFFECT OF CONSENT ORDER (a) Waiver. Byconsenting to the entry ofthis Order, the Company waives its rights to file objections to this Orderpursuant to section 5(e)(l)(C) ofTSCA, to receive service ofthis Orderno later than 45 days before the end ofthe review period pursuant to section 5(e)(l)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to beboundbyits terms, do not constitute an adinissionbythe Company as to the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights thatthe Company mayhave under TSCA.
(b) CBI Brackets. 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 bythe Company (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFRPart 2) is correctly identified within brackets and that any information that is notbracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information containedwithin the brackets. 

# fLo 

# Ap?u'JdDJ3

Date

# {f~ol:j Date MariaJ. Doa, Ph.D , irector Chemical Control Division Office ofPollution Prevention and ToxicsATTACHMENT A DEFINITIONS [Note: The attached Order may not contain some of the terms defined below.] "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed bythe Chemical Abstracts Service's rules of nomenclature, or a name which will clearly identify a chemical substance for the purpose of conducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protectivebarrier to prevent dermal contact with chemical substances ofconcern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves,jackets, and pants. "Company'' means the person orpersons subject to this Order. "Commercial use" means the use ofa chemical substance or anymixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Commonname" means any designation oridentification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other thanbyits chemical name. "Consumer" means a private individual who uses a chemical substance or anyproduct containing the chemical substance in or around a permanent or temporaryhousehold or residence, during recreation, or for anypersonal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold ormade available to consumers for theiruse in or around a permanent or temporary household orresidence, in or around a school, orinrecreation. "Container" means anybag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, orthe like that contains a hazardous chemical. For purposes ofthis section, pipes orpiping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Contract Manufacturer" means a person, outside the Company, who is authorized to manufacture and import the PMN substance under the conditions specified in Part II. ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity'' means any chemical or common name used to identify a chemical substance or a mixture containing that substance. ·2 "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is under the control of, and used onlyby, the person who transferred it from a labeled container and will onlybeused bythat person within the work shift in which it is transferred from the labeled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance ·causes no chemical or mechanical degradation, permeation, orpenetration ofthe chemical protective clothing under the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment "MSDS"means material safety data sheet, the written listing ofdata for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health ofthe U.S. Department ofHealth and Human Services. "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, ormixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemical substance and the workplace airmay occur. "Non-industrial use" means use other than at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice
· submitted bythe Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the bodyto prevent contact with, and exposureto, an identified chemical substance or substances in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types ofrespirators. Barrier creams are not included in this definition. "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-reviewed protocol or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency reviewthatprevents

### a reasoned evaluation ofthe health or environrnental.effects ofthe PMN substance.3 "Scientifically equivocal data" means data which, although developed in apparent conformitywith the Good Laboratory Practice Standards and EPA-reviewed protocols, are inconclusive, internally inconsistent, or otherwise insufficientto permit a reasoned evaluation of thepotential risk ofinjuryto human health orthe environment ofthe PMN substance. "Sealed container" means a closed containerthat isphysically and chemically suitable for long-term containment ofthe PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumeruse. "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, orused and where employees arepresent "Workplace" means an establishment at onegeographic location containing one ormore work areas.Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER

PMNNumber
1. Transfer ofManufacture 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 premanufacture notice ("PMN") and is governedby a Consent Order issued bythe U.S. Environmental Protection Agency ("EPA") under the authority of§S(e) ofthe Toxic Substances Control Act ("TSCA," 15 U.S.C. §2604(e)).
2. Assumption ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed bythe applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall bethe responsibility ofthe Successor in Interest. Successorin Interest also certifies that itis incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(a)(3).
3. Confidential Business Information. The Successor in Interest hereby: reasserts, _·_relinquishes, or modifies all Confidential Business Information ("CBI") claims madebythe Company, pursuant to Section 14 ofTSCA and 40 CFRpart 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. Information which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBI bythe original submitter) would not subsequentlybe eligible for confidential treatment under this Notice ofTransfer.NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER (continued) Company (Transferor) PMNNumber
Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official

Successor in Interest
Signature ofAuthorized Official Date
Printed Name ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code

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


### Phone