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REGULATION OFA NEWCHEMICALSUBSTANCE PENDING DEVELOPMENT OF INFORMAT10N

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# Polf;--**~o** Consent Order and Determinations Supporting Consent Order11 TABLE OFCONTENTS

Preamble I. Introduction ll. SummaryofTerms ofthe Order Ill. Contents ofPMN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health and Environmental Effects

Consent Order I. Scope ofApplicability and Exemptions ll. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation Ill. Record-keeping IV. SuccessorLiability Upon TransferofConsent Order V. Modification and Revocation ofConsent Order VI. Effect ofConsent Order
Attachment A
- Definitions Attachment B - Notice ofTransferofConsent Order111 I. INTRODUCTION Underthe authority of§ 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached Order, regarding premanufacture notice ("PMN") P-04-80 submittedby [ ] ("the Company"), to take effect upon expiration ofthe PMN review period. Under§ 15 ofTSCA, it is unlawful for any person to fail orrefuse to comply with any provision
' of§ 5 or any orderissued under§ 5. Violators maybe subject to 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 subjectto the§ 12(b) export notice requirement.

II. SUMMARY OFTERMS OFTHE ORDER The Consent Orderfor this PMN substance requires the Company to: (1 ) submit to EPAcertain toxicity testing at least 14 weeks before manufacturing orimporting a total of ] kilograms ofthe PMN substance; (2) provide personal protective equipment to its workers to prevent dermal exposure; (3) label containers ofthe PMN substance and provide Material Safety Data Sheets (MSDSs) and workertraining in accordance with the provisions ofthe Hazard Communication Program section; (4) distribute the PMN substance only to a person who agrees to follow the same restrictions (except the testing requirements) and to not further distribute the PMN substance until it has been completely reacted;IV (5) complywith the Release to Waterprovisions; and (6) maintain certain records.

III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order): Companyname, chemical identity, production volume, manufacturing and processing information, and otherinformation. Chemical Identity: Specific: [ Generic: Halogen-substituted oxetane Use: Monomerfor use in the production ofreactive polymers for surface coating materials and other polymerintermediates. Maximum 12-Month Production Volume: [ Test Data Submittedwith PMN: none ] kg/yr

IV. EPA'S ASSESSMENT OF RISK The following are EPA'spredictions regarding the probable human and environmental toxicity ofthe PMN substance, based on the information currently available to the Agency. Human Health Summary: 

### Absorption: EPA expects 20 percent absorption ofthe PMN chemical via skin, 100 percent via the lungs and 60 percent via the GItract.

### v Toxicological Endpoints ofConcern and Basis for Concerns: Toxicological endpoints ofconcern include male reproductive effects and systemic effects. EPA analysis ofdata on one analogue ofoxetane concluded a no-observable-adverse-effect level (NOAEL) of 100 mg/kg/day in a 28-day oral toxicity study based on liver and thyroid abnormalities at higherdose levels. EPA analysis ofdata on another oxetane analogue concluded a NOAEL of200 mg/kg/day in a 28-oral toxicity study based on increases in liver and kidney weights and adverse effects
on male reproductive organs, in particular, atrophy ofseminiferous tubules in testes and decrease in spermin epididymus lumen at higher dose levels. EPA does not considerthe intact PMN substance to be analogous to [
]. 

### Riskto Occupational Workers: EPA expects up to 1750 mg/day dermal exposure during use ofthe PMN substance, resulting in a Margin ofExposure (MOE) of22, indicating a high risk to workers via dermal exposure. Environmental Effects Summary: EPAcalculates the aquatic Concentration ofConcern (CoC) to be 5 parts perbillion (ppb) based on a Structure Activity Relationship (SAR) analysis for oxetanes (see www.epa.gov/oppt/newchems/chemcat.htm). The PMN parent material is also predicted to be a persistent, bioaccumulative and toxic (PBT) chemical. EPA models predicted the log Kow to be 4.9 and the fish bioconcentration factor (BCF) to be 3.0. Undercertain conditions, the PMN substance maybreakdown to produce [
on related [ ] compounds. ]. EPA is in the process ofevaluating testingVI Exposure and Environmental Release Summary: Manufacture ofmonomer Use ofmonomer to produce polymer #Sites [ ] [ ] Workers with dermal exposure [ ] [ ] (#/site) Exposure [ ] [ ] (days/year) Dermal Exposure up to 1,750 up to 1,750 (mg/day) Drinking Water Exposure (mg/day) Not expected Not expected Release to Water Not expected Not expected (kg/day)
V. EPA'S CONCLUSIONS OFLAW The following findings constitute the basis ofthe Consent Order: A. EPA is unable to determine the potential for human health and environmental effects from exposure ofhumans and aquatic organisms to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) ofTSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation ofthe human health and environmental effects ofthe PMN substance. B. 

### 1n light ofthe potential risk ofhuman health and environmental effects posedby the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, and the Agency's conclusion that issuing the Orderwill not result in any significant loss ofbenefits to society, EPA has concluded, pursuant to§ 5(e)(l)(A)(ii)(l) 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.Vll 

### C. In light ofthe estimated production volume of, and human exposure to, the PMN substance, EPA has further concluded, pursuant to § 5(e)( 1 )(A)(ii)(II) ofTSCA, that the PMN substance will be produced in substantial quantities and may reasonably be anticipated to enterthe environment in substantial quantities, and there may be significant (or substantial) human exposure to the substance.

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 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 ofthis Order in accordance with the conditions specified in the Testing section. Pending Testing. The following additional information would be required to evaluate the environmental toxicity and persistent, bioaccumulative, and toxic characteristics which may be associated with the PMN substance: 1) Algal toxicity test (OPPTS 850.5400); 2) Aquatic invertebrate acute toxicitytest (OPPTS 850.1010); 3) Fish acute toxicitytest (OPPTS 850.1075); 4) PBT testing: log Kow test (OECD 117). Ifthe log Kow test results in an Agencybioaccumulation rating ofB2 orgreater, then the fish bioconcentration factor (BCF) test (OPPTS 850.1730) should be conducted. Ifthe tested fish BCFis greater than 1000 and results in an AgencyB2 rating orgreater, then the 90-day sub-chronic rat-oral toxicity test (OPPTS 870.3100) should be conducted. The Order does not require submission ofthe above pended testing at any specified time or production volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance will remain in effect until the Order is modified
orrevoked byEPA based on submission ofthat orotherrelevant information.CONSENT ORDER

I. SCOPE OFAPPLICABILITY AND EXEMPTIONS (a) Scope. Therequirements ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe chemical substance [ ] (P-04-80)("the PMN substance") in the United States by [ ] ("the Company"), except to the extent that those activities
are exemptedbyparagraph (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 SuccessorLiabilityUponTransferOfConsent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section ofthis Order.2 (1) Completely Reacted (Cured). The requirements ofthis Order do not apply to quantities of the PMN substance that have been completelyreacted (cured). (2) De Minimis Concentrations. The requirements ofthis Order do not apply to quantities of the 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 of this Order). This exemption is not available ifthe Company has reason to believe that, during intended activities, the PMN substance in the mixture may be reconcentrated above the 1.0 or0.1 percent level, whichever applies. (3) Export. Until the Companybegins commercial manufacture ofthe PMN substance for use in the United States, the requirements ofthis Orderdo not apply to manufacture, processing or distribution in commerce ofthe PMN substance solely for export in accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to manufacture the PMN substance for use in the United States, no further activity by the Company involving the PMN substance is exempt as "solely for export" 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 ofthe United States. Prior to leaving U.S. territory, even those quantities orbatches ofthe PMN substance that are destined for export are subject to terms ofthe Order, and count towards any production volume test triggers in the Testing section ofthis Order. (4) 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 small3 quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), I and 40 CFR 720.36. (5) Byproducts. The requirements ofthis Orderdo 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). (6) No Separate Commercial Purpose. The requirements ofthis Order do not apply to the PMN substance when it is manufactured, pursuant to any ofthe exemptions in 40 CFR 720.30(h), with
no commercial purpose separate from the substance, mixture, or article ofwhich it is a part.
(c) Automatic Sunset. Ifthe Companyhas obtained for the PMN substance a Test Market Exemption (TME) underTSCA §5(h)(l) and 40 CFR 720.38 ora Low Volume Exemption (LYE) or Low Release and Exposure Exemption (LoREX) underTSCA §5(h)(4) and 40 CFR 723.50(c)(l) and (2) respectively, any such exemption is automaticallyrendered null and void as ofthe effective date ofthis Consent Order.
II. TERMS OF MANUFACTURE. IMPORT. PROCESSING, DISTRIDUTION IN COMMERCE. USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OFINFORMATION ] ("the Company") is prohibited from manufacturing, importing, processing, distributing in commerce, using, ordisposing ofthe chemical substance [ ] (P04-80) ("the PMN substance") in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health and environmental effects ofthe substance, and4 the completion ofEPA'sreview of, and regulatory action based on, that information, except under the following conditions:

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 ofinjury to health orthe environment, which is required to be reported underEPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), 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 in the reporting guide referenced at 68 Federal Register 33129 (June 3, 2003).
(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA Laboratory Data IntegrityBranch (2225A), 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 be performed pursuant to this Order, or within 15 days after the effective date ofthis Order, whichever is later: 1. The date when the study is scheduled to commence; 2. The name and address ofthe laboratory which will conduct the**~;tudy;** and 3. The name and telephone number ofa person at the Company orthe laboratory whom EPA maycontact regarding the study.5 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 studyrequired to be performed 

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. pursuantto this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CFRPart 792 and using methodologies generally accepted at the time the study is initiated. Before starting to conduct any study, the Company must obtain approval oftest protocols from EPA by submitting written protocols. EPA will respond to the Company within 4 weeks ofreceiving the written A protocols. Published test guidelines specified in paragraph (d) provide general guidance for development oftestprotocols, but are not themselves acceptable protocols. (d) Triggered Testing Requirements. The Company is prohibited from manufacturing orimporting the PMN substance beyond an aggregate manufacture and import volume of [ , ] kilograms ("the production limit"), unless the Company conducts a combined repeated dose study with a reproductive/developmental toxicity screening in rats by gavage (Test Guideline OPPTS 870.3650/0ECD422) 1on the PMN substance and submits all final reports and underlying data in accordance with the conditions specified in this Testing section. (e)**Te~lt** Reports. The Company shull: (1) conduct ouch study in good fnith, with due cure, und in u scientifically valid manner; (2) promptly furnish to EPA the results ofany interim phase ofeach study; and (3) submit, in triplicate (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA no later

1Study should be modified to include pre-dosing for a full sperm cycle (70 days).

### 6 than 14 weeks prior to exceeding the applicable production limit. 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 information is mandatory. EPA will require the submission ofraw data such as slides and laboratory notebooks onlyifEPA finds, on the basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannot take place in the absence ofthese items.
(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. IfEPA finds that the data generated by a study are scientifically equivocal, the Company maycontinue to manufacture and import the PMN substance beyond the applicable production limit. To seekrelieffrom any otherrestrictions ofthis Order, the Company may make a second attempt to obtain unequivocal databyreconducting the study under the conditions specified in paragraphs (b), (c), and (e)(l) and (2). The testing requirements may be modified, as necessary to permit a reasoned evaluation ofthe risks presentedby the PMN substance, only by 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 receipt ofa test report and data, the Company receives written notice that EPA finds7 that the data generatedby a study are scientifically invalid, the Company is prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Company may continue to manufacture and import the PMN substance beyond the applicable production limit only ifso notified, in writing, by EPA in response to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Company may reconduct the study in compliance with paragraphs (b), (c), and (e)(l) and (2). 

### Ifthere is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Companyto complywith subparagraph (e)(3), the Companymay exceed the production limit and shall submit the report and data in triplicate to EPA within a reasonable period oftime, all as specified byEPA in the notice described in subparagraph (h)(1 ). 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)(l), submit to EPA a written report refuting EPA's finding. EPAwill respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.
(i) CompanyDetermination 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, or have prevented, development ofscientifically valid data under the conditions specified in paragraphs (c) and (e), the Companyremains prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit.

# .. 9 testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposures to or to better characterize the risks presented by the PMN substance. Within 2 weeks from receipt ofsuch a notice, the Company mustcease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance, unless either: (2) within 2 weeks from receipt ofthe notice described in subparagraph U)( 1 ), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks from receipt ofthe notice described in subparagraph U)(l), 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 ofreceiving 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 manufacture, import, processing, distribution, use and disposal ofthe PMN substance.
(k) Other Requirements. Regardless ofthe satisfaction ofany otherconditions in this Testing section, the Company must continue to obey all the terms ofthis Consent Orderuntil otherwise notified in writing byEPA. The Company may, based upon submitted test data orotherrelevant information, petition EPA to modify or revoke provisions ofthis Consent Orderpursuant to Part IV. ofthis Consent Order.10 PROTECTION IN THEWORKPLACE (a) During manufacturing, processing, and use ofthe PMN substance at any site controlled by the Company, the Company must establish a program whereby:· (1) Dermal Protection. Each person who is reasonably likely to be dermallyexposed in the work area to the PMN substance through direct handling ofthe substance orthrough contact with equipment on which the substance may existis provided with, and is required to wear, personal protective equipment that provides 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 must be selected and used in accordance with 29 CFR 1910.132 and 29 CFR 1910.133. (2) Specific Dermal Protective Equipment. In addition to the personal protective equipment described in subparagraph (a)(l) ofthis section, the following items are required: (i) Gloves. (ii) Chemical goggles orequivalent eyeprotection (3) Demonstration ofImperviousness. The Company is able to demonstrate that each item of chemical protective clothing selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within the work area by any one ora combination ofthe following: (i) Imperviousness Testing. Testing the material used to make the chemical protective clothing and the construction ofthe clothing to establish that the protective clothing will be impervious for the expected duration and conditions ofexposure. The testing must subject the chemical protective clothing to the expected conditions ofexposure, including the likely combinations ofchemical substances to which the clothing may be exposed in the work area. Permeation testing shall be11 conducted according to the American Society for Testing and Materials (ASTM) F739 "Standard Test Method for Resistance ofProtective ClothingMaterials to Permeation by Liquids or Gases." Results shall be reported as the cumulative permeation rate as a function oftime, and shall be documented in accordance with ASTM F739 using the format specified in ASTM F1194-89 "Guide for Documenting the Results ofChemical PermeationTesting on Protective Clothing Materials." Gloves may not be used for a time period longer than they are actuallytested and must be replaced at the end ofeach work shift. (ii) Manufacturer's Specifications. Evaluating the specifications from the manufacturer
or supplierofthe chemical protective clothing, orofthe material used in construction ofthe clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likelycombination with otherchemical substances in the work area.
(b) Low Concentrations in Mixtures. Ifthe PMN substance is present in the work area only as a mixture, the Company is exempt from the provisions ofthis Protection in the Workplace section ifthe concentration ofthe PMN substance in the mixture does not exceed 1.0 percent by weight or volume,
or0.1 percentby weight orvolume ifparagraph (g) ofthe Hazard Communication Program section of this Orderidentifies cancer as a potential human health hazard ofthe PMN substance. This exemption does not apply ifthe Companyhas reason to believe that during intended use orprocessing in the work area, the PMN substance in the mixture may be concentrated above the 1.0 or0.1 percent level, whicheveris applicable.12 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 of warning material will be satisfied. The Companymust make the written hazard communication program available, upon request, to all employees, contractoremployees, and their designated representatives. The Companymayrely on an existing hazard communication program, including an existing program established underthe Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1910.1200), to comply with 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 be present in the work area which are subject to a TSCA section 5(e) consent order signedbythe Company orto a TSCA section 5(a)(2) SNUR at 40 

### C.F.R. Part 721, subpart E. The list must be maintained in each work area where the PMN substance is known to be present and must use the identity provided on the MSDS for the substance required underparagraph (c) ofthis section. The list may be compiled for the workplace or for individual work
areas. Ifthe Companyis required eitherby another Order issued under section 5(e) ofTSCA orby a TSCA section**~(u)(2)** SNtJR ut 40 CFR Purt 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 substancecontained in unlabeled pipes in their work area.13 (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 contractorwork in the Company's workplace and are reasonably likely to be exposed to the PMN substance while in the Company's workplace.
(b) Labeling. (1) The Company shall ensure that each container ofthe substance in the workplace is labeled in accordance with this subparagraph (b)(I). (i) The label shall, at a minimum, contain the following information: (A) A statement ofthe health hazards(s) and precautionary measure(s), ifany, identified in paragraph (g) ofthis section orby the Company, for the PMN substance. (B) The identity by which the PMN substance may be commonlyrecognized. (C) A statement ofthe environmental hazard(s) and precautionary measure(s), ifany, identified in paragraph (g) ofthis section, or by the Company, for the PMN substance. (D) A statement ofexposure and precautionary measure(s), ifany, identified in paragraph (g) ofthis section, orbythe Company, for the PMN substance. (ii) The Company may use signs, placards, process sheets, batch tickets, operating procedures, orother such written materials in lieu ofaffixing 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)(1)(i) ofthis section. Any written materials mustbe readily accessible to the employees in their work areas throughout each work shift.14 (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 ordeface an existing label on containers ofthe PMN substance obtained from persons outside the Companyunless the containeris immediately relabeled with the information specified in subparagraph (b)(l)(i) ofthis section. (2) The Companyshall 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)(1)(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 ofwarning, shall be legible and prominentlydisplayed. (4) The label, oralternative forms ofwarning, shall be printed in English; however, the information maybe repeated in otherlanguages. (5) Ifthe label oralternative form ofwarning is to be applied to a mixture containing the PMN substance in combination with any other substance that is either subject to anotherTSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721,15 subpartE, or defined as a "hazardous chemical" under the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS, or alternative form ofwarning, the measures to control worker exposure
orenvironmental release which the Companydetermines provide the greatest degree ofprotection. However, should these control measures differfrom the applicable measures required under this Order, the Companymust seek a determination ofequivalency for such alternative control measures pursuant to 40CFR721.30 before prescribing them underthis subparagraph (b)(5).
(c) Material SafetyData 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) The identity used on the containerlabel ofthe PMN substance under this section, and, ifnot claimed confidential, the chemical and common name ofthe PMN substance. Ifthe chemical and common name are claimed confidential, a generic chemical name 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. (iv) Thepotential human and environmental hazards as specified in paragraph (g) of this 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.16 (vi) The primary routes ofexposure to the PMN substance. (vii) Precautionary measures to control workerexposure and/or environmental release required by this Order, or alternative control measures which EPA has determined under40 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 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, work practices, or personal 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) Where multiple mixtures containing the PMN substance have similarcompositions (i.e., the chemical ingredients are essentially the same, but the specific composition varies from mixture to mixture) and similarhazards, the Company may prepare one MSDS to apply to all ofthese multiple mixtures.17 (5) Ifthe Companybecomes aware ofany significant new information regarding the hazards of the PMN substance orways to protect against the hazards, this new information must be added to the MSDS 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 Company must add the new information 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 theirinitial shipment and with the first shipment after an MSDS is revised. The Companymay eitherprovide the MSDS with the shipped containers or send it to the person priorto orat the time ofshipment. (7) The Company must maintain a copyofthe MSDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work areas. (8) The MSDS may be kept in any form, including as operating procedures, and maybe designed to cover groups ofsubstances in a work area where it maybe more appropriate to address the potential hazards ofa process rather than individual substances. However, in all cases, the required information mustbe provided 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 must be printed in English; however, the information maybe repeated in other languages.
(d) Employee Information and Training. The Company must ensure that employees are provided with information and training on the PMN substance. This information and training must be provided at the18 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) The infm'mation provided to employees under this paragraph shall include: (i) The requirements ofthis section. (ii) Anyoperations in the work area where the PMN substance is present. (iii) The location and availability ofthe written hazard communication programrequired underparagraph (a) ofthis section, including the list ofsubstances required by subparagraph (a)( 1) of this section and MSDSs required byparagraph (c) ofthis section. (2) The training provided to employees shall include: (i) Methods and observations that may be used to detect the presence orrelease ofthe PMN substance in orfrom an employee's work area (such as monitoringconducted by the Company, continuous monitoring devices, visual appearance, orodorofthe substance when being released). (ii) The potential human health and environmental hazards ofthe PMN substance as specified in paragraph (g) 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 me1.unues to control workerexposure and/or environmental release required under this Order, or alternative control
measures which EPA has determined under40 CFR 721.30 provide the same degree ofprotection as the specified control measures.19 (iv) The requirements ofthe hazard communication program developed by the Companyunder this section, including an explanation ofthe labeling system and the MSDS required by this section and guidance on obtaining and using appropriate hazard information.
(e) Low Concentrations in Mixtures. Ifthe PMN substance is present in the work area only as a mixture, the Company is exempt from the provisions ofthis section ifthe concentration ofthe PMN substance in the mixture does not exceed 1.0 percent by weight or volume, or0.1 percent by weight or volume ifparagraph (g) ofthis section identifies cancer as a potential human health hazard ofthe PMN substance. However, this exemption does not apply ifthe Companyhas reason to believe that during intended use orprocessing in the work area, the PMN substance in the mixture may be reconcentrated above the 1.0 or0.1 percent level, whichever is applicable.
(f) Existing Hazard Communication Program. The Company need not take additional actions ifexisting programs and procedures satisfy the requirements ofthis section.
(g) Human Health, Environmental Hazard, Exposure, and Precautionary Statements. The following human health and environmental hazard and precautionary statements shall appearon 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) male reproductive effects (ii) systemic effects (2) Human hazard precautionary statements. When using this substance:(i) avoid skin contact. (ii) use skin protection. 20

(3) Environmental hazard statements. This substance maybe: (i) toxic to fish. (ii) toxic to aquatic organisms. (iii) persistent, bioaccumulative and toxic. ( 4) Environmental hazard precautionary statements. Notice to users: (i) do not release to water. (5) The human and environmental hazard and precautionary statement contained on a label prepared pursuantto paragraph (b) ofthis section must be followed by the statement: "See the MSDS for details."

MANUFACTURING (a)(l) The Company shall not cause, encourage, or suggest the manufacture or import ofthe PMN substance by any otherperson. (2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days afterpromulgation of
a final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) ofTSCA unless the Companyis 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.

### 21 (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 notifyeach person whom it causes, encourages or suggests to manufacture or import the PMN substance ofthe existence ofthe SNUR. Such notification must be in writing and must specifically include 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 of the SNUR for this PMN substance in eitherthe Federal Register orthe Code ofFederal Regulations.

DISTRIBUTION (a) Distribution Requirements. Except as provided in paragraph (b), the Company shall distribute the PMN substance outside the Company, including for disposal, only to a person who has agreed in writing prior to the date ofdistribution, to: (1) Not further distribute the PMN substance to any otherperson, including for disposal, until afterthe PMN substance has been completelyreacted. (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 Companyin the Hazard Communication Program section ofthis Order. (4) Complywith the same environmental release restrictions, ifany, required ofthe Company in the Release to Water section ofthis Order.

### 22 (b) TemporaryTransport and Storage. Notwithstanding paragraph (a), the Company may distribute the PMN substance outside the Company for temporary transport and storage in sealed containers (labelled in accordance with paragraph (b)(2) ofthe Hazard Communication Program section ofthis Order) provided that any human exposure orenvironmental release resulting from opening the container and removing orwashing outthe PMN substance may occuronly while the PMN substance is in the possession and control ofthe Companyora person authorized to receive the PMN substance from the Companypursuant to this Distribution section ofthis Order.
(c) Recipient Non-Compliance. If, at anytime 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 (a) ofthis Distribution section or, after paragraph (a)(l) expires in accordance with subparagraph (d)(l), has engaged in a significant new use ofthe PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, the Company shall cease supplying the substance to that recipient, unless the Company is able to document each ofthe following: (1) That the Company has, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe conditions specified in paragraph (a) ofthis Distribution section, orhas engaged in a significant new use ofthe PMN substance without submitting a significant
new 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 (a) ofthis Distribution section and will comply with those terms, or is aware ofthe terms

### 23 ofthe significant new use rule for the PMN substance and will not engage in a significant new use without submitting a significant new use notice to EPA. (3) If, afterreceiving a statement ofassurance from a recipient under subparagraph (c)(2) of this Distribution section, the Company obtains knowledge that the recipient has failed to comply with any ofthe conditions specified in paragraph (a) 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 ofthe failure to comply, and shall resume supplying the PMN substance to that recipient only upon written notification from the Agency.
(d) Sunset Following SNUR. (1) Paragraph (a)(l) ofthis Distribution section shall expire75 days afterpromulgation ofa final SNUR for the PMN substance under section 5(a)(2) ofTSCA, unless the Companyis notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Companyis so notified, paragraph (a)(l) ofthis Distribution section shall not expire until EPA notifies the Companyin writing that all Federal Court actions involving the SNURhave been resolved and the validity ofthe SNUR affirmed. (2) When EPA promulgates a final SNUR for the PMN substance and paragraph (a)( 1) ofthis Distribution sectionexpires in uccordance with subparagraph (d)( 1 ), the Company shull notify euch person to whom it distributes the PMN substance ofthe existence ofthe SNUR. Such notification must be in writing and must specifically include 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 in24 eitherthe Federal Register or the Code ofFederal Regulations. After promulgation ofa SNUR and expiration ofsubparagraph (a)( 1 ), such notice may substitute for the written agreement required in the introductoryclause ofparagraph (a); so that, ifthe Companyprovides such notice to the persons to whom it distributes the PMN substance, then the Company is not required to obtain from such persons the written agreement specified in paragraph (a).

RELEASE TO WATER (a) The Companyis prohibited from any predictable orpurposeful release ofthe PMN substance, or any waste stream from manufacturing, processing, or use ofthe PMN substance into the waters ofthe United States.
III. RECORD-KEEPING 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 copying by EPA in accordance with section 11 ofTSCA: (1) Records documenting the aggregate manufacture and importation volume ofthe PMN substance and the corresponding dates ofmanufacture and import; (2) Records documenting the names and addresses (including shipment destination address, if different) ofall persons outside the site ofmanufacture or import to whom the Company directly sells or transfers the PMN substance, the date ofeach sale or transfer, and the quantity ofthe substance sold or transferred on such date;25 (3) Records documenting establishment and implementation ofa program for the use ofany applicable personal protective equipment required pursuant to the Protection in the Workplace section ofthis Order; (4) Records documenting the determinations required by the Protection in the Workplace section ofthis Order that chemical protective clothing is impervious to the PMN substance; (5) Records documenting establishment and implementation ofthe hazard communication program required bythe 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 bythe Hazard Communication Program section ofthis Order; (8) Records documenting compliance with any applicable manufacturing and distribution restrictions in the Manufacturing and Distribution sections ofthis Order; (9) Records documenting establishment and implementation ofprocedures that ensure compliance with any applicable water discharge limitation in the Release to Water section ofthis Order; (1

0) Copies ofany Transfer Documents and notices required by the SuccessorLiability section ofthis Order, ifapplicable; and (11) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substance is manufactured, imported, processed orused.
(b) Applicability. The provisions ofthis Record-keeping Section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Company's customers.

### 26
(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of information" unless this Order displays a currently valid control number from the Office ofManagement and Budget (OMB), and EPA so informs the Company. The "collection ofinformation" required in this TSCA 5(e) Consent Order has been approved under currently valid 

### OMB Control Number 2070- 0012.

IV. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Company's rights and obligations under this Ordermaybe transferred 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 "Successorin Interest").
(b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Company to the Successorin 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 Successorin Interest must submit a
new PMN to EPA and complyfully with Section 5(a)(l) ofTSCA and 40 CFR part 720 before commencing manufacture orimport ofthe PMN substance.27 (2) After NOC. Ifthe transfer from the Company to the Successor in Interest is effective after EPAreceives a NOC, the Successorin Interest shall comply with the terms ofthis Order and is not required to submit a new PMN to EPA.
(c) Definitions. The following definitions apply to this Successor Liability section ofthe Order: (1) "Successorin 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 by the Company, as transferor, and the Successorin Interest, as transferee. The term excludes persons who acquire less than the full interest of the 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 Successorin Interest must be incorporated, licensed, ordoing business in the United States in accordance with 40 CFR 720.22(3). (2) "Transfer Document" means the legal instrument(s) used to convey the interests in the PMN substance, including the right to manufacture the PMN substance, from the Companyto the Successor in Interest.
(d) Notices. (1) Notice to Successorin Interest. On orbefore 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 by reference as Attachment C to this Order.

### 28 (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 Branch (7405M), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document must be maintained by the Successorin Interest at its principal place ofbusiness, and at all sites where the PMN substance is manufactured orimported. Copies ofthe Transfer Document must also be made available for inspection pursuant to Section 11 ofTSCA, must state the effective date and time oftransfer, and must contain provisions which expressly transfer liability for the PMN substance under the terms ofthis Orderfrom the Companyto the Successorin Interest.
(e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective date and time ofthe transfer described above. (2) The Successorin Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date and time 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 terms ofthis Consent Order.

### 29 (f) Obligations to SubmitTest Data under Consent Order. Ifparagraph (d) ofthe Testing section of this Consent Orderrequires the Company to submit test data to EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMN substance manufactured and imported by the Company up to the date oftransfer shall count towards the test trigger applicable to the Successor in Interest.

V. MODIFICATION AND REVOCATION OF CONSENT ORDER The Companymay petition EPA at any time, based upon new information on the health or environmental effects of, human exposure to, orenvironmental release of, the PMN substance, to modifyorrevoke substantive provisions ofthis Order. The exposures and risks identified byEPA duringits review ofthe PMN substance and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessment ofthe test data orotherinformation that supports the findings in this Order, an examination ofnew test data or otherinformation or analysis, and any otherrelevant information. EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will not present un unrensonuble risk ofinjury to health or the environment and will ntlt result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficient to permit a reasoned evaluation ofthe health orenvironmental effects ofthe PMN substance. 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 the30 modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.

### VI. EFFECT OF CONSENT ORDER By consenting to the entry ofthis Order, the Company waives its rights to file objections to this Order pursuant 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, or modifications made thereto, in any subsequent action. Consenting totheentry ofthis Order, and agreeing to be bound by its terms, does not constitute
an admission bythe Company as to the facts or conclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights that the Company mayhave underTSCA.

Date Office of



### _L !_.// 

### Name: Title: Company:_..

### ,ATTACHMENT A DEFINITIONS 

### [Note: The attached Ordermaynotcontain some ofthe terms defined below.] "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed by the International Union ofPure and Applied Chemistry or the Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identify a chemical substance for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protective barrier 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 any mixture 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). "Common name" means any designation oridentification such as code name, code number, trade name, brand name, orgeneric chemical name used to identify a chemical substance other than by its chemical name. "Consumer" means a private individual who uses a chemical substance or any product containing the chemical substance in oraround a permanent ortemporary household orresidence, during recreation, orfor any personal use orenjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold or made available to consumers for their use in or around a permanent ortemporary household or residence, in or around a school, orin recreation. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, orthe like that contains a hazardous chemical. Forpurposes 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 Orderfor Contract Manufacturer. "Identity" means any chemical orcommon name used to identify a chemical substance or a mixture containing that substance.2 "Immediatb 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 from a labeled container and will only be used by that person within the work shift in which it is transferred from the labelled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical ormechanical 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 orconcentration, through all intended operations of manufacture, 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-enclosedprocess" means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulkchemical substance and the workplace air may occur. "Non-industrial use" means use other than at a facility where chemical substances ormixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice submittedby the Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the bodyto prevent contact with, and exposure to, 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. Barriercreams are not included in this definition. "Process stream" means all reasonably anticipated transfer, flow, ordisposal ofa chemical substance, regardless ofphysical state orconcentration, through all intended operations ofprocessing, including the cleaning ofequipment. "Scientificallyinvalid" means any significant departure from the EPA-approved protocol orthe GoodLaboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency approval that prevents a reasoned evaluation ofthe health orenvironmental effects ofthe PMN substance.

### 3 "Scientificallyequivocal data" means data which, although developed in apparent conformity with the Good LaboratoryPractice Standards and EPA-approved protocols, are inconclusive, internallyinconsistent, orotherwise insufficient to permit a reasoned evaluation ofthe potential risk of injury to human health orthe environment ofthe PMN substance. "Sealedcontainer" means a closed container that is physically and chemically suitable for longterm containmentofthe 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 orconcentration, through all intended operations ofindustrial, commercial, orconsumeruse. "Waters ofthe United States" has the meaning set forth in 40 CFR 122.2. "Work area" means aroom or defined space in a workplace where the PMN substance is manufactured, processed, orused and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROLACT SECTION 5(e) CONSENT ORDER
P04-80 PMN Number
1. TransferofManufacture 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 governed by a Consent Order issued by the U.S. Environmental Protection Agency (EPA) under the authority of §5(e) ofthe Toxic Substances Control Act (TSCA, 15 U.S.C. §2604(e)).
2. Assumption ofLiability. The Successorin Interest hereby certifies that, as ofthe effective date of transfer, all actions oromissions governed by the applicable Consent Orderlimiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with40 CFR 720.22(3).
3. Confidential Business Information. The Successor in Interest hereby:

_ reasserts,

_ relinquishes, or modifies all Confidential Business Information (CBI) claims made by the Company, pursuant to Section 14 of TSCA 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 ofTransfer.TOXIC SUBSTANCES CONTROLACT SECTION 5(e) CONSENT ORDER

NOTICE OFTRANSFER (cont.) P04-80 Company (Transferor) PMN Number 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