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UNITED STATES ENVIRONMENTALPROTECTION AGENCY OFFICE OFPOLLUTION PREVENTIONAND TOXICS

REGULATION OF A NEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT OFINFORMATION

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Consent Order and Determinations Supporting Consent Order-11- 

### TABLE OF CONTENTS
Preamble I. 

### Introduction IT. Summary ofTerms ofthe Order ill. 

### Contents ofPMN IV. EPA's Assessment ofExposure and Risk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health

Consent Order I. 

### Scope ofApplicability and Exemptions IT. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation ill. 

### Record-keeping IV. Requests for Pre-Inspection Information V. SuccessorLiability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order
Attachment A Definitions Attachment B- Statistical Analysis ofNCELs Analytical Method Verification Results Attachment C - Notice ofTransfer ofConsent Order-m

## PREAMBLE
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") P04-834 for the chemical substance [
] (the "PMN substance") submittedbyArch Chemicals ("the Company"), to take effectupon expiration ofthe PMN review period. The Company submitted the PMNto EPApursuant to section 5(a)( 1) ofTSCA and 40 CFRPart720. Under§ 15 ofTSCA, it is unlawful for any person to fail orrefuse to comply with anyprovision of§ 5 or any order issuedunder§ 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 of TSCA, such as this one, are subjectto the § 12(b) export notice requirement.

II. SUMMARY OF TERMS OF THE ORDER The Consent Order for this PMN substance requires the Company to: ( 1 ) submit to EPAcertain toxicity testing at least 14 weeks before manufacturing or importing a total of [ ] kilograms (Tier I) and [ ] (Tier

# m ofthe PMN substance; (2) provide personal protective equipment to its workers to prevent dermal exposure;-IV- (3) provide respirators with a minimum Assigned Protection Factor (APF) of25 to its workers to prevent inhalation exposure; (4) as an alternative to using respirators, maintain workplace airborne concentrations ofthe PMN substance at orbelow a specified New Chemical Exposure Limit ("NCEL") of0.05 mg/m3 as an 8- hour time-weighted average, verified by actual exposure monitoring data (To pursue this option, a sampling and analytical method must be developed by the Company, verified by an independent thirdpartylaboratory, and submitted to EPA.); (5 ) label containers ofthe PMN substance and provide Material Safety Data Sheets (MSDSs) and workertraining in accordance with the provisions ofthe Hazard Communication Program section; (6) distribute the PMN substance only to a person who agrees to follow the samerestrictions (except the testing requirements) and to not further distribute the PMN substance until it has been completely reacted; and (7 ) maintain certain records.



### III. CONTENTS OF PMN Confidential Business Information Claims (Bracketed in the Preamble and Order): Chemical identity, production volume, otherinformation Chemical Identity: Specific: [

Generic: HDIBiuret, hydroxyethyl methacrylate prepolymer-vUse: As an ingredient in 2-componentpolyurethane coatings Maximum 12-Month Production Volume: [ ] kg/year Test Data Submitted with PMN: none



### IV. EPA'S ASSESSMENT OFEXPOSURE AND RISK The following are EPA's predictions regarding the probable human toxicity ofand exposure to the PMN substance, basedon the information currently available to the Agency. Human Health Effects Summary: ToxicologicalEndpoints and Basis for Concern: The concerns for the PMN substance are potential dermal and respiratory sensitization and pulmonary toxicity and carcinogenicity from the PMN substance ifinhaled. Based onconflicting animal and human datafor respiratory sensitization, the Agencyhas determined that there is presently not a reliable animal model for testing diisocyanates for potential respiratory sensitization. At this time, it is assumed that all diisocyanates maybe potential human respiratory sensitizers. See www.epa.gov/oppt/newchems/chemcat.htm Exposure and Environmental Release Summary: Manufacture Process Use #Sites Not Applicable (N/A) NIA 50 #ofWorkers withExposure (Total) NIA N/A 1,000 Exposure (days/year) N/A N/A 250 Dermal Exposure N/A N/A 1,700 (liquid at 20% PMN (mglday) concentration) InhalationExposure NIA N/A 48 (worst-case) (mglday) 0.2 (typical) Drinking WaterExposure N/A N/A .00405 (mglday/day)-VlRiskto Workers: Based on Structural ActivityRelaionship (SAR) analysis derived from test data on structurally similar diisocyanates, there is a risk to workers for dermal and pulmonary sensitization and irritation and possible pulmonarytoxicity and carcinogenicityfrom the PMN substance ifinhaled.

NIOSH Assigned Protection Factor (APF): New Chemical Exposure Limit: 0.05 mg/m3 as an 8-hour time-weighted average (TWA).



### V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: (a) EPAis unable to determine the potential for pulmonary sensitization and irritation in addition to possiblepulmonarycarcinogenicity from exposure ofhumans to the PMN substance. EPAtherefore 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 effects ofthe PMN substance.
(b) In light ofthe potential risk ofpulmonary sensitization and irritation in addition to possible pulmonarycarcinogenicityposedby the 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 may present an unreasonable risk ofinjury to human health.(c) Inlight ofthe estimated production volume of, and human exposure to, the PMN substance, EPA has further concluded, pursuant to§ 5(e)(l)(A)(ii)(II) ofTSCA, that the PMN substance will be produced in substantial quantities and there may be significant (or substantial) human exposure to the substance.



### VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH EFFECTS Triggered Testing. The Order prohibits 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.

## CONSENT ORDER

I. SCOPE OFAPPLICABILITY AND EXEMPTIONS (a) Scope. The requirements ofthis Orderapplyto all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe chemical substance [ ] (P04-834) ("the PMN substance") in the United States by Arch Chemicals Inc.("the Company"), except to the extent that those activities are exempted by paragraph (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 SuccessorLiability Upon Transfer OfConsent 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.
(1) Completely Reacted (Cured). The requirements ofthis Order do not apply to quantities of the PMN substance that have been completelyreacted (cured).2 (2) De Minimis Concentrations. The requirements ofthis Orderdo not applyto 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 orvolume (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 Companyhas 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 Only. 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 40 CFR 720.3(s). However, once the Companybegins to manufacture the PMN substance for usein the United States, no further activitybythe Companyinvolving the PMN substance is exempt as "solely for export" even ifsome amount ofthe PMN substance is laterexported. 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 small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), and40 CFR720.36.

### 3 (5) Byproducts. Therequirements ofthis Orderdo not apply to the PMN substance when it is produced, without separate commercial intent, only as a "byproduct" as defined at40 CFR 720.3(d) and in compliance with 40CFR 720.30(g). (6) No Separate Commercial Purpose. Therequirements ofthis Order do not apply to the PMN substance when it is manufactured, pursuant to any ofthe exemptions in 40 CFR720.30(h), with
no commercial purpose separate from the substance, mixture, orarticle 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 40CFR 720.38 ora Low Volume Exemption (LVE) orLow Release and ExposureExemption (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 OFMANUFACTURE. IMPORT. PROCESSING, DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OFINFORMATION
PROHIBITION The Companyis prohibited from manufacturing, importing, processing, distributing in commerce, using, ordisposing ofthe PMN substance in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation of the human health effects ofthe substance, and the completion ofEPA'sreview of, andregulatory action4 based on, that information, exceptin 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 ofinjury to health orthe environment, which is requiredtobereported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70 Federal Register 2162 (January 12, 2005), shall reference the appropriate PMN identification numberfor this substance and contain a statement that the substance is subject to this Consent Order. Additional information regarding section 8(e) reporting requirements canbe found in the reporting guide referenced at 56 Federal Register 28458 (June 20, 1991).

(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPALaboratory Data Integrity Branch (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 study; (3) The name and telephone number ofa person at the Companyorthe laboratory whomEPA may contact regarding the study; and

### 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 study required to be performed pursuant to this Order mustbe conducted according to TSCA Good Laboratory Practice Standards at 40 CFRPart 792 and using methodologies generally accepted in the relevant scientific community at the time the studyis initiated. Before starting to conduct any study, the Companymust obtain approval oftest protocols from EPAby submitting written protocols to EPA. EPAwill respond to the Company within 4 weeks ofreceiving the written protocols. Published test guidelines specified in paragraph (d) provide general guidance for development oftest protocols, but are not themselves acceptable protocols. EPA approval ofa test protocol does not mean pre-acceptance oftest results.
(d) Triggered Testing Requirements. The Companyis prohibited from manufacturing orimporting the PMN substancebeyond the following aggregate manufacture and import volumes ("the production limits"), unless the Company conducts the following studies on the PMN substance and submits all final reports and underlying data in accordance with the conditions specified in this Testing section.
Production Limit (kilograms) Tier 1: [ ]
TierII: [ ] Dermal sensitization test 90-day subchronic inhalation Toxicity test in rodents Guideline (OPPTS 870.2600) (OPPTS 870.3465)6
(e) TestReports. 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, intriplicate (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPAno later than 14 weeks priorto 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 clearthat the submission ofsuchinformation is mandatory. EPA will require the submission ofraw data such as slides and laboratorynotebooks only ifEPA finds, on the basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannot take place in the absence ofthese items.
(f) TestingWaivers. The Company is not required to conduct a study specified in paragraph (d) ofthis Testing section ifnotified in writing byEPAthat it is unnecessary to conduct that study.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Companymaycontinue to manufacture and import the PMN substance beyond the applicable production limit. To seek relieffrom any otherrestrictions ofthis Order, the Company may make a second attempt to obtain unequivocal data byreconducting the study underthe conditions specified in7 paragraphs (b), (c), and (e)(l) and (2). The testing requirements maybe modified, as necessary to permit a reasoned evaluation ofthe risks presentedbythe PMN substance, onlyby mutual consent of EPA and the Company.
(h) EPADetermination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report and data, the Companyreceives written notice that EPA finds that the data generated by a study
are scientificallyinvalid, the Companyis prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Company maycontinue to manufacture and import the PMN substance beyond the applicable production limit onlyifso notified, in writing, byEPA in response to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Company mayreconduct 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 complywith subparagraph (e)(3). Ifthere is insufficient time for the Company to comply with subparagraph (e)(3), the Company may 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 Company may, within 4 weeks ofreceiving from EPAthe notice described in

### 8 subparagraph (h)(l), 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 orlaboratory will prevent, orhave prevented, development ofscientificallyvalid 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. (2) The Company may submitto EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearlybeyond the control ofthe Company orlaboratory will cause orhave caused development ofscientifically invalid data. EPA will notifythe Company ofits response, in writing, within 4 weeks ofreceiving the Company's report. EPA's written response may either: (i) allow the Companyto continue to manufacture and import the PMN substance beyond the applicable production limit, or (ii) require the Companyto continue to conduct, orto reconduct, the study in compliance with paragraphs (b), (c), and (e)(1) and (2). Ifthere is sufficient time to conduct or 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 complywith subparagraph (e)(3). Ifthere is insufficient time for the Company to comply with subparagraph (e)(3), the Company9 may exceed the production limit and shall submit the report and data in triplicate to EPAwithin 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 ofreceiving the Company's report and data, as to whether the Company may continue to manufacture and importbeyond the applicable production limit. (j) Unreasonable Risk. (1) EPA may notifythe Company in writing that EPAfinds that the data generatedby a study
are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substance will ormaypresent an unreasonable risk ofinjuryto human health orthe environment. EPA's notice may specifythat the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposures to or to better characterize the risks presented bythe PMN substance. Within 2 weeks from receipt ofsuch
a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal of the PMN substance, unless either: (A) within 2 weeks from receipt ofthe notice described in subparagraph (j)(l), the Company complies with such requirements as EPA's notice specifies; or (B) within 4 weeks from receipt ofthe notice described in subparagraph (j)(l), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness ofany additional requirements imposedby EPA. The Company may continue to manufacture, import, process, distribute, use and dispose ofthe PMN substance in accordance with the terms ofthis Order pending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within10 4 weeks ofreceiving the Company's report. Within 2 weeks ofreceipt ofEPA's written response, the Company shall comply with any requirements imposedbyEPA's response orcease 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 terms ofthis Consent Order until otherwise notified in writing byEPA. The Company may, based upon submitted test data orotherrelevant information, petitionEPA to modifyorrevokeprovisions ofthis Consent Orderpursuant to Part N. ofthis Consent Order.

PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. During manufacturing, processing, and use ofthe PMN substance at any site controlledbythe Company (including any associated packaging and storage and during any cleaning ormaintenance ofequipment associated with the PMN substance), the Companymust 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 orthrough contact with equipment on which the substance mayexist, orbecause the substance becomes airborne in a form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, personal protective equipment that provides abarrierto prevent dermal exposure to the substance in the specific work area where it is selected for use. Each such item ofpersonal protective equipment must be11 selected and used in accordance with OSHAdermal protection requirements at 29 CFR 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 items are required: (i) Gloves. (ii) Full body chemical protective clothing. (iii) Chemical goggles orequivalent eye protection. (iv) Clothing which covers any otherexposed areas ofthe arms, legs and torso. (3) Demonstration ofImperviousness. The Company is able to demonstrate that each item of chemical protective clothing selected, including gloves, provides an impervious barrierto prevent dermal exposure during normal and expected duration and conditions ofexposure within the work area byany 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 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 likelycombinations ofchemical substances to which the clothing maybeexposed in the work area. Permeation testing shall be conducted according to the American Society for Testing and Materials (ASTM) F739 "Standard Test Method for Resistance ofProtective Clothing Materials to Permeation byLiquids 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 Fll94-89 "Guide for Documenting12 the Results ofChemical Permeation Testing on Protective ClothingMaterials." Gloves may notbe used for a time period longerthan they 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 chemicalprotective clothing will be impervious to the PMN substance alone and in likelycombination with otherchemical substances in the work area. (4) Respiratory Protection. Each person who is reasonably likely to beexposedby inhalation in the work area to the PMN substance in the form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, at a minimum, a NIOSH-certified Category I respirator (Assigned Protection Factor2 25), from the respirators listed in subparagraph (a)(6) ofthis section, and the respirator is used in accordance with OSHA and NIOSH respiratoryprotection requirements at 29 CFR 1910.134 and42 CFR Part 84. All respirators mustbe issued, used, and maintained according to an appropriate respiratoryprotection program under the Occupational Safety and Health Administration (OSHA) requirements in 29 CFR 1910.134. (5)Physical States. The following physical states ofairborne chemical substances are listed for subparagraphs (a)(l) and (4) ofthis section: (i) Combination GasNaporand Particulate (gas and liquid/solid physical states are both present; a good example is paint spray mist, which contains both liquid droplets and vapor). (6) Authorized Respirators. The following NIOSH-certified respirators meet the minimum requirements for subparagraph (a)(4) ofthis section:13 !{Data on Cartridge Service 

### Lite Testing has been ReviewedandApprovedby (I) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with the appropriate combination cartridges. Cartridges should be tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include a particulate filter (NlOO ifoil aerosols are absent, RIOO, or PlOO). (II) NIOSH-certified powered air-purifying respirator equipped with a loose fitting hood orhelmet and the appropriate combination cartridges. Cartridges shouldbe tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include HEP A filters. (III) NIOSH-certified powered air-purifying respirator equipped with a tightfitting facepiece (full-face) and the appropriate combination cartridges. Cartridges shouldbe tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include HEPA filters. (IV) NIOSH-certified supplied-airrespirator operated in pressure demand or continuous flow mode and equipped with a hood orhelmet, ortight-fitting facepiece (full-face). !{No Cartridge Service 

### Life Testing isAvailable: (V) NIOSH-certified supplied-airrespirator operated in pressure demand or continuous flow mode and equipped with a hood orhelmet, ortight-fitting facepiece (full-face).

NEW CHEMICAL EXPOSURE LIMIT (a) Alternative to Requirements ofRespirator Section.14 (1) EPA recommends and encourages the use ofpollution prevention, source reduction, engineering controls and workpractices, rather than respirators, as a means ofcontrollinginhalation exposures wheneverpracticable. (2) Whenever a person is reasonablylikely to beexposed to the PMN substance byinhalation,
as an alternative to compliance with the respirator requirements in the Protectionin the Workplace section ofthis Order, the Company maycomplywith the requirements ofthis New Chemical Exposure Limit section. However, before the Companymay deviate from the respirator requirements in the Protection in theWorkplace section ofthis Order, the Company must: (i) submittoEPA a copy ofthe Company's sampling and analytical method for the PMN substance, verified in accordance with subsection (c)(3) ofthis New Chemical Exposure Limit section; (ii) obtain exposure monitoring results in accordance with this New Chemical Exposure Limit section; and (iii) based on those exposure monitoring results, select, provide, and ensure use if necessary ofthe appropriate respiratory protection specified inparagraph ( e)(2) ofthis New Chemical Exposure Limit sectionbypersons who are reasonably likely to be exposed to the PMN substance by inhalation. (3) After appropriate respiratoryprotection has been selected at a workplace based on the results ofactual exposure monitoring conducted in accordance with this New Chemical Exposure Limit section, the Company shall not, at that workplace, use the respiratoryprotection required in the Protection in the Workplace section ofthis Order (unless it is the same as required bythis New15 Chemical Exposure Limit section).
(b) Exposure Limit. (1) General. The following new chemical exposure limit (NCEL) for the PMN substance is an interimlevel determinedbyEPA based on the limited information available to the Agency at the time of development ofthis Order. The NCEL for the PMN substance is as follows: (i) Time-Weighted Average (TWA) Limit. The Company shall ensure that no person is exposed to an airborne concentration ofthe PMN substance in excess of0.05 mg/m3 (the NCEL) as
an 8-hourtime-weighted average, without using a respirator in accordance with subsection (e) ofthis New Chemical Exposure Limit section. (ii) Non-8-HourWork-shifts. Fornon-8-hour work-shifts, the NCELfor that workshift (NCELn) shall be determinedbythe following equation: NCELn = NCEL x (8/n) x [(24-n)/16], where n =thenumber ofhours in the actual work-shift. (2) Automatic Sunset. If, subsequent to the effective date ofthis Order, the Occupational Safety and Health Administration (OSHA) promulgates, pursuant to §6 ofthe Occupational Safety and Health Act, 29 U.S.C. 655, a final chemical-specific permissible exposure limit (PEL) specifically applicable to this PMN substance and the OSHA PEL is not challenged in court within 60 days ofits promulgation, then any respirator requirements in the Protection in the Workplace section ofthis Order and anyrequirements ofthis New Chemical Exposure Limit section applicable to workers and situations subject to the OSHA PEL shall automatically become null and void. However, the requirements ofthis Consent Order are not negated by any pre-existing OSHA PEL applicable to the16 PMN substance.
(c) Performance-Criteriafor Sampling and Analytical Method. (1) Applicability. Forinitial development and validation ofthe sampling and analytical method for the PMN substance, all the requirements ofthis subsection (c) apply. For subsequent exposure monitoring conductedpursuant to subsection (d) ofthis New Chemical Exposure Limit section, onlythe following requirements apply: (c)(4)(i), (4)(ii), (4)(iv)(B), (4)(v)(B), (8), and (9). Any deviation from the requirements ofthis subsection (c) mustbe approved in writing byEPA. (2) Submission ofVerified Method and Certification Statement. The Company shall submit to EPA a copy ofa validated sampling and analytical method for the PMN substance which satisfies the criteria specified in this subsection (c). The method description shall expressly state how the method compares with each quantitative requirement specified in this subsection (c). The submission must include a written statement, signed byauthorized officials ofboth the Company and the Laboratory, certifying the truth and accuracy ofthe independent laboratory verification conducted pursuantto subsection (c)(3). To assist EPA in identifying the document, it shall state in a conspicuous, underlined subject-line at the top ofthe first page: "NCELSampling and Analytical Method for PMN # P04- 834," after-which the correct PMN number for this chemical substance shall be stated. (3) Verification ofAnalytical Method by Independent Third-PartyLaboratory. (i) Verification. The Company shall have an independent reference laboratory ("Laboratory") verify the validity ofthe analytical method for the PMN substance, in accordance with the otherrequirements in this subsection (c)(3). Itis the Company's responsibility to ensure that the17 Laboratory complies with all the requirements specified in this subsection (c)(3). (ii) Independent Reference Laboratory. The independent reference laboratory must be
a separate and distinct person (as defined at 40 CFR 720.3(x)) from the Company and from any other person who may have developed the method for the Company. (iii) Accreditation. The Laboratory must be accredited by a formally recognized government orprivate laboratory accreditation program for chemical testing and/or analysis. (iv) Good Laboratory Practice Standards. The Laboratory verification ofthe analytical method for the 

### PMN substance must comply with TSCAGood LaboratoryPractice Standards (GLPS) at 40 CFR Part 792. [Certain provisions ofthe TSCA GLPS applicable to toxicity testing in laboratory animals, such as 40 CFR 792.43 ("Test systemcare facilities"), 792.45 ("Test system supply facilities") and 792.90 ("Animal and othertest system care"), are clearly inapplicable to the NCELrequirements.] However, compliance with TSCA GLPS is not required underthis New Chemical Exposure Limit section where the analytical method is verifiedbya laboratory accreditedby either: (A) the American Industrial Hygiene Association (AIHA) Industrial Hygiene Laboratory Accreditation Program (IHLAP); or (B) another comparable program approved in advance in writing byEPA. (v) Analysis ofDuplicate Samples. The Company shall collect six duplicate samples (a total of 12) at the TWA concentration. The samples shall be taken either from a controlled environment (e.g., a sealed chamberor "glove box") which closely resembles the actual workplace conditions or, for solids and liquids with very low vapor pressure, by injecting the PMN substance onto
a sample collection device. The duplicate samples shall be collected on identical collection media, at18 the same time, and under the same conditions. One set ofsix samples shall immediatelybe analyzed by the Company, the other set ofsix samples shall be analyzed by the Laboratory using the method developed byor for the Company. (vi) Sample Storage Study. Ifthe results ofthe analysis ofduplicate samples pursuant to paragraph (c)(3)(v) do not satisfy the requirements in paragraph (c)(3)(vii), the Companymust perform a sample storage study as follows: (I) Triplicate Samples. The Company shall collect six triplicate samples (atotal of 18) at the TWAconcentration. The samples shall be taken either from a controlled environment (e.g., a sealed chamber or "glove box") which closely resembles the actual workplace conditions or, for solids and liquids with very low vaporpressure, byinjecting the PMN substance onto a sample collection device. The triplicate samples shall be collected on identical collection media, at the same time, and underthe same conditions. One set ofsix samples shall immediatelybe analyzed bythe Company. (ll) Analysis After Sample Storage. A sample storage evaluation shall be performed with the two remaining sets ofsix samples. One set ofsix samples shall be analyzed by the Laboratoryusing the method developed by or for the Company, and the other shall be analyzed bythe Company on the same day as the Laboratory analyzes its six samples. Specialized storage conditions for the samples including extraction conditions, time from sampling to extraction, time from collection or extraction (ifapplicable) to analysis and storage conditions must be specified in the method description.
(vii) Comparison ofResults. The difference between the results ofthe two sets ofsix19 samples analyzed bythe Laboratory and the Company as required in eitherparagraph (c)(3)(v) or (c)(3)(vi)(ll) shall be evaluated using a two-sample t-test with unequal variances, and the two sides of the criticalregions shall not exceed a 5% significance level. (See Attachment B

- Statistical Analysis of NCELs Analytical Method Verification Results.) The average ofeach set ofsix samples mustbe within 10% ofthe true value. Ifthe average ofeach set ofsix samples is not within 10% ofthe true value, then the sample storage time between collection and analysis mustbereduced until the average ofeach set ofsix samples is within 10% ofthe true value. (4) Accuracy. The sampling and analytical method must clearly demonstrate the following: (i) General. The sampling and analytical method, and all exposure monitoring data relied on bythe Company, shall be accurate to within ±25% at a 95% confidence level for concentrations ofthe PMN substance ranging from one halfthe NCELto twice the NCEL. (ii) NCEL Quantitation Limits. The analytical method shouldbe capable ofreliably quantifying the PMN substance across the full range ofreasonably likelyexposures. At a minimum, the analytical method must be capable ofreliably quantifying from a lower quantitation limit ("LQL") ofone halfthe NCELto an upper quantitation limit ("UQL") ofat least twice the NCEL. Ifthe Company obtains an exposure monitoring sample that is more than 10% above the actual UQL ofthe analytical method, the Companymust comply with paragraph (e)(4)(i). (iii) Lower QuantitationLimit Signal-To-Noise Ratio. The analytical method shall be capable ofquantifying the PMN to a concentration ofone halfthe NCELwith a signal that is at least five times the baseline noise level. Baseline noise must be amplified to a measurable level when possible, even ifthe required amplification is beyond that used in routine analysis ofsamples. (If20 baseline noise cannotbe obtained, another reference must be selected. This maybe a peak considered tobe noise causedbythe reagent matrix.) The sampling preparation method must be specified and the detection limit for the analytical procedure mustbe reported as mass perinjection for chromatographic techniques. (iv) Instrument Calibration. (I) Initial Calibration. For method development and validation (but not subsequent exposure monitoring), the initial calibration shall at a minimum consist offive (5) calibration standards with a linearcorrelation of0.95

-- these five (5) calibration standards must consist ofone standard at each ofthe following concentrations: one halfthe NCEL (0.5 x NCEL); between one half and one times the NCEL (0.5 x NCEL

### < > 1 x NCEL); one times the NCEL (1 x NCEL); between
one and two times the NCEL (1 x NCEL

### <> 2 x NCEL), and twice the NCEL (2 x NCEL). (ill) Continuing Calibration. During each week ofboth method development/validation and subsequent exposure monitoring, the Company shall conductboth an initial instrument calibration and a continuing calibration. The Company shall perform at least one continuing calibration sample at the NCEL concentration, and at least one additional calibration sample perevery 10 samples analyzed. The continuing calibration sample shall fall within±25% ofthe initial calibration value. Ifnot, then the initial calibration must be repeated, and any samples associated with that outlying calibration check mustbe re-analyzed. (v) Calculated Percent Recovery. (I) Initial Calculation. Formethod development and validation, the Company must calculate the percent ofthe PMN substance recovered by the analytical method from a sample21 containing a known quantity ofthe PMN substance. The sample shall be taken either from a controlled environment (e.g., a sealed chamber or "glove box") which closelyresembles the actual workplace conditions or, for solids and liquids with very low vaporpressure, by injecting the PMN substance onto
a sample collection device. (Such a sample is referred to as a "matrix spike"). The calculated percent recovery for each matrix spike shall be greater than or equal to 75% and less than orequal to 125%. Spike concentrations for the PMN substance must be included in the sampling and analytical method submitted to EPA. (II) Subsequent Calculation. During each subsequent exposure monitoring episode orcampaign, at least 1matrix spike, prepared by injecting the PMN substance onto a sample collection device, shall be analyzed. (This matrix spike must be prepared at the NCELconcentration.) (vi) Sampling Device Capacity. The capacity ofthe sampling device must be tested and results reported to show under a known and well-defined set ofconditions that the device is capable ofcollecting the new chemical in solid, liquid or vapor phase with minimal loss. The sampling device's capacity (air volume and collected analyte mass) must be specified. For methods that use adsorbent tubes as the collection medium, evidence ofthe capacity must be provided in the form of breakthrough testing. This testing must be done at a concentration twice the NCEL and under conditions similar to those expected in the workplace. Breakthrough is defined to have occurred when the concentration ofthe PMN substance in the effluent stream is equal to 5% ofthe concentration ofthe influent stream, orwhen 20% ofthe PMN substance is detected in the backup section ofthe sampler. (vii) Sampling Device Desorption Efficiency. Where applicable, the desorption efficiency must be evaluated for the air sampling device. A minimum ofsix air samples spiked with the22 PMN substance at least the NCEL concentration must be prepared. A recovery ofat least 75% must be obtained for each ofthe six samples. (5) Precision. The estimate ofthe coefficient ofvariation ofeach set ofsix samples from the controlled atmosphere test (spiked at 1.0 NCEL, perparagraphs (c)(3)(v) or (vi)) must be less than 0.105, including allowance of0.05 for error due to sampling. (6) Interpretation ofAccuracy and Precision Data. (i) Ifa single matrix spike recovery is less than 75% recovery or greater than 125% or the estimated precision is greater than 0.105, then the Company must re-prepare the matrix spike, resample, and re-analyze all samples associated with such matrix spike ortriplicate samples. (ii) Forpercent recoveries less than 90% but greater than 75%, correction for low recovery is required. Correct for recovery first by dividing the observed amount by the proportion recovered before determining ifmeasurements fall below the NCEL. For example, ifthe observed level is 30 mg/m3 and the percent recovery is 75%, use the value 30 mg/m3/(0.75) 

## =40 mg/m3 when determining whether the levels are below the exposure limit. (7) Representativeness. All sample conditions used to develop the methodology shall mimic the actual workplace environment expected to be monitored. Conditions such as the temperature, humidity, lighting, and presence ofother chemicals, etc. must mimic the conditions in the workplace to be monitored. (8) Changes Affecting Validity. Ifthe workplace environment changes from the initial conditions described in the verified sampling and analytical method in a way reasonably likely to invalidate the accuracy ofthe method, then the Company must comply with the respirator requirements23 in the Protection in the Workplace section ofthis Order, unless the Companyre-validates the method to confirmthat the requirements for accuracy and precision in paragraphs (c)(4) and (5) are met. Examples ofpossible changes include but are not limited to: introduction ofa new chemical substance to the workplace which may interfere with the analysis ofthe new chemical; introduction oflight to the workplace which may interfere with a light-sensitive PMN substance; or introduction of water/increased humidity to the workplace which could react with the PMN substance and cause difficulties in collection and analysis. (9) Comparability. All data and results shall be reported in the same units ofmeasurement as the NCEL. (10) Responsibility for Method Validity. The independent laboratory verification and EPA receipt ofthe sampling and analytical method pursuant to this subsection (c) do not ensure that the method will produce valid exposure monitoring data. The Companyis ultimately responsible for ensuring the validity ofits exposure monitoring data.
(d) Monitoring Potential Exposure. (1) General. (i) Action Level. The "action level" is defined as an airborne concentration ofthe PMN substance, calculated as an 8-hourtime-weighted average, equal to one halfthe NCELTWA specified in subparagraph (b)(1). Fornon-8-hour work shifts, the action level is equal to one halfthe NCELn. (The NCELn is described in subparagraph (b)(l)(ii).) The Company may exceed the action level without penalty. The purpose ofthe action level is solely to determine the requisite monitoring24 frequency. (ii) Representative Exposure Groups. Wheneverexposure monitoring is requiredby this New Chemical Exposure Limit section, the Company shall take representative samples ofwhat the potential exposure ofeach person who is reasonably likely to be exposed to airborne concentrations of the PMN substance would be ifrespirators were not worn. The Company shall do so by sampling the breathing zone air ofat least one person that represents, and does not underestimate, the potential exposure ofeveryperson performing the same or substantially similar operations in each work shift, in eachjobclassification, in each work area (hereinafter identified as an "exposure group") where inhalation exposure to the PMN substance is reasonably likely to occur. Theexposure ofeach person need not be itselfdirectly sampled ifthat exposure is represented by sampling the exposure ofanother person in the same exposure group. (iii) Good Laboratory Practice Standards. Determinations ofpotential inhalation exposure shall be made according to TSCA Good LaboratoryPractice Standards at 40 CFR Part 792 and the sampling and analytical method developed pursuant to subsection (c) ofthis New Chemical Exposure Limit section. [Certain provisions ofthe TSCA GLPS applicable to toxicity testing in laboratory animals, such as 40CFR 792.43 ("Test system care facilities"), 792.45 ("Test system supplyfacilities") and 792.90 ("Animal and other test system care"), are clearly inapplicable to the NCELrequirements.] However, compliance with TSCA GLPS is not required where exposure monitoring samples are analyzed by a laboratory accredited by either: (A) the American Industrial Hygiene Association (AIHA) Industrial Hygiene Laboratory Accreditation Program (IHLAP); or (B) anothercomparable program approved in advance in writing by EPA.

### 25 (iv) Full Shift Exposure Samples. Representative 8-hour TWA airborne concentrations shall be determined on the basis ofsamples representing the full shift exposure for each exposure group.
(2) Initial Monitoring. Before the Company may deviate from the respiratorrequirements of the Protection in the Workplace section, the Company shall conduct initial exposure monitoring to accurately determine the airborne concentration ofthe PMN substance for each exposure group in which persons are reasonably likely to be exposed to the PMN substance. (3) Periodic Monitoring. (i) Ifany representative samples taken during the initial exposure monitoring reveal an airborne concentration at or above the action level but at orbelow the TWA, the Company shall repeat the exposure monitoring for that exposure group at least every 6 months. Ifthe PMN substance is not manufactured, processed, orused at all during a given 6 month calendarperiod, the Company is not required to conduct exposure monitoring until manufacture, processing, oruse ofthe PMN substance is resumed. However, cessation ofmanufacturing, processing and use ofthe PMN substance for less than the 6 month period does not constitute grounds for postponement ofthe 6 month deadline to conduct exposure monitoring. (ii) Ifany representative samples taken during the initial exposure monitoring reveal an airborne concentration above the TWA, the Company shall repeat the exposure monitoring for that exposure group at least every 3 months. Ifthe PMN substance is not manufactured, processed, or used at all during a given 3 month calendarperiod, the Companyis not required to conduct exposure monitoring until manufacture, processing, or use ofthe PMN substance is resumed. However,

### 26 cessation ofmanufacturing, processing and use ofthe PMN substance for less than the 3 month period does not constitute grounds for postponement ofthe 3 month deadline to conduct exposure monitoring. (iii) The Company may alter the exposure monitoring schedule from every 3 months to every 6 months for any exposure group for whom two consecutive measurements taken at least 7 days apart indicate that the potential exposure has decreased to the TWA orbelow, but is at or above the action level. Where the PMN substance is manufactured, processed, orused in batches ofduration less than 7 days, the 2 consecutive measurements maybe taken at least 24 hours apart, provided that the measurements accurately reflect the highest peak exposures and variability in exposure. ( 4) Termination ofMonitoring. (i) Ifrepresentative samples taken during the initial exposure monitoring reveal an airborne concentration below the action level, the Company may discontinue monitoring for that exposure group, except when additional exposure monitoring is required by paragraph (d)(5) ofthis New Chemical Exposure Limit section. (ii) Ifrepresentative samples taken during the periodic monitoring reveal that an airborne concentration, as indicated by at least 2 consecutive measurements taken at least 7 days apart,
are below the action level, the Company may discontinue the monitoring for that exposure group, except when additional monitoring is required by paragraph (d)(5) ofthis New Chemical Exposure Limit section. Where the PMN substance is manufactured, processed, orused in batches ofduration less than 7 days, the 2 consecutive measurements may be taken at least 24 hours apart, provided that the measurements accurately reflect the highest peak exposures and variability in exposure.

### 27 (5) Additional Monitoring. (i) For a previously monitored exposure group, the Company shall, within 7 days of any ofthe events listedbelow in this paragraph (d)(5)(i), conduct the initial exposure monitoring followed by any periodic or additional exposure monitoring required by subsection (d) ofthis New Chemical Exposure Limit section: (I) change in the production volume, process, control equipment, personnel or workpractices that mayreasonably cause new or additional exposures to the PMN substance; 

# em spills, leaks, ruptures orotherbreakdowns occurthat mayreasonably
cause new or additional exposures to the PMN substance; and (III) whenever else the Companyhas any reason to suspect a change that may reasonablyresult in new or additional exposures to the PMN substance. (ii) In no event is the additional exposure monitoring requirement in paragraph (d)(5)(i) intended to delay implementation ofany necessarycleanup orotherremedial action. During any cleanup orremedial operations that may occurbefore commencing additional exposure monitoring, the Company shall ensure that potentially exposed persons use at least the respiratory protection specified in subsection (e) for the measured airborne concentration, ormore protective respiratory equipment deemed appropriate bythe bestprofessionaljudgment ofa qualified expert. (6) Notification ofMonitoring Results. (i) Within 15 working days after receipt ofthe results ofany exposure monitoring required bythis Order, the Company shall notify each person whose exposure is represented bythat monitoring. The notice shall identify the NCEL, the exposure monitoring results, and any corresponding

### 28 respiratoryprotection required by subsection (e). Affected persons shall be notified in writing either individually orby posting the information in an appropriate and accessible location. (ii) Wheneverthe NCEL is exceeded, the written notification required bythe preceding paragraph shall describe the action being taken by the Company to reduce inhalation exposure to orbelow the NCEL, or shall refer to a document available to the person which states the actions to be taken to reduce exposure. (7) Exemption based on Objective Data. Where the Company has documented and reliable objective data demonstrating that, even under worst-case conditions, employee exposure to the PMN substance will not exceed the action level (defined in paragraph (d)(l)(i)) underthe expected handling procedures and conditions for a specific "exposure group" (defined in paragraph (d)(l)(ii)), then that exposure group is exempt from this New Chemical Exposure Limit section (except paragraph (d)(5) "Additional Monitoring" and subsection (f) "NCEL Record-keeping") and the respirator requirements in the Protection in the Workplace section ofthis Order. Any such objective data must accurately characterize actual employee exposures to the PMN substance and must be obtained under conditions closelyresembling the types ofmaterials, processes, control methods, work practices, and environmental conditions in the Company's current workplace operations with the PMN substance. Examples ofobjective data that maybe used to demonstrate that employee exposure will not exceed the action level, even under worst case conditions, include information on the physical and chemical properties ofthe PMN substance, industry-wide studies, and/or laboratory test results.
(e) Respiratory Protection.29 (1) General. Whenever the Company has conducted exposure monitoring at a workplace in accordance with subsection (d) ofthis New Chemical Exposure Limit section and the measured airborne concentration ofthe PMN substance for any person who is reasonably likely to be exposedto the PMN substance by inhalation exceeds the NCEL, the Company shall provide those persons the respirators specified in this subsection (e) (ratherthan the respirator(s) identified in the Protection in the Workplace section ofthis Order), and shall ensure that the respirators are used (including training, fit testing, and maintenance) in accordance with OSHA and NIOSH respiratory protection requirements at 29 CFR 1910.134 and 42 CFR Part 84. When the Company has not yet measured the airborne concentration ofthe PMN substance at a workplace in accordance with this New Chemical Exposure Limit section, the Company shall comply with the respirator requirements in the Protection in the Workplace section ofthis Order at that workplace. (2) Selection ofAppropriate Respiratory Protection. After the Company has conducted exposure monitoring in accordance with subsection (d) ofthis New Chemical Exposure Limit section, the Company shall select, provide, and ensure that persons who are reasonably likely to be exposed to the PMN substance by inhalation use, at a minimum, the respiratory protection which corresponds in the following table to the measured airborne concentration (or a more protective respirator which corresponds to a concentration higher than measured). [(Data on Cartridge Service Life Testing has been ReviewedandApprovedby EPA:**~** NIOSH-certified air-purifying, tight-fitting full-face respirator equipped with the appropriate combination cartridges. Cartridges should be tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include a particulate30 filter (NIOO ifoil aerosols are absent, RIOO, or PIOO).

,.. NIOSH-certified powered air-purifying respirator equipped with a loose fitting hood or helmet and the appropriate combination cartridges. Cartridges should be tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include HEPA filters
.

... NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (full-face) and the appropriate combination cartridges. Cartridges should be tested and approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include HEPA filters.

,.. NIOSH-certified supplied-airrespirator operated in pressure demand orcontinuous flow mode and equipped with a hood or helmet, ortight-fitting facepiece (full-face). lfNo Cartridge Service Life Testing isAvailable:

,.. NIOSH-certified supplied-airrespirator operated in pressure demand orcontinuous flow mode and equipped with a hood or helmet, ortight-fitting facepiece (full-face).
(3) Reductions in Respiratory Protection. After appropriate respiratory protection has been selectedbased on the results ofactual exposure monitoring conducted at a workplace in accordance with subsection (d) ofthis New Chemical Exposure Limit section, the Company shall not, at that workplace, use the respiratory protection required by the Protection in the Workplace section ofthis Order (unless it is the same as required by this New Chemical Exposure Limit section). Before the31 Company may make any reduction in any respiratory protection selected pursuant to this New Chemical Exposure Limit section, the Company must verify, by 2 consecutive measurements taken at least 7 days apart, that the new respiratoryprotection is appropriate in accordance with paragraph ( e)(2). Where the PMN substance is manufactured, processed, orused in batches ofduration less than 7 days, the 2 consecutive measurements maybe taken at least 24hours apart, provided that the measurements accuratelyreflect the highest peak exposures and variability in exposure. (4) Special Situations. (i) Measurements Outside Quantitation Limits. When a value less than the lower quantitation limit ("LQL") ofthe analytical method (as described in paragraph (c)(4)(ii)) is measured, the Company shall estimate potential exposure using generally established and accepted statistical methods. Ifthe Company obtains an exposure monitoring sample that is more than 10% above the actual upperquantitation limit (UQL) ofthe analytical method, the Company must ensure that its workers wear at least a NIOSH-certified supplied-airrespirator operated in pressure demand orother positive pressure mode and equipped with a tight-fitting full facepiece. Any reductions in this respiratoryprotection mustcomply with paragraph (e)(3). The Companymay submit an improved analytical method provided that it complies fully with subsection (c) ofthis New Chemical Exposure Limit section, including the verification required by subsection (c)(3). (ii) Cleanup and Remedial Actions. During any special cleanup orother remedial actions that may occur before commencing additional exposure monitoring (as discussed in paragraph (d)(5)(ii)), the Company shall ensure that potentially exposed persons use at least the respiratory protection specified above in this subsection (e) for the measured airborne concentration, ormore32 protective respiratory equipment deemed appropriate by the best professionaljudgment ofa qualified expert.
(f) NCEL Recordkeeping. (1) Wheneverthe Company elects to comply with this New Chemical Exposure Limit section ratherthan the respirator requirements in the Protection in the Workplace section ofthis Order, the Company shall maintain the following records until 30 years after the date they are created, and shall make them available for inspection and copying by EPA in accordance with section 11 ofTSCA: (i) A copy ofthe sampling and analytical methods used and continuing evidence oftheir accuracy overtime as required by section (c); (ii) Records documenting compliance with the analytical method verification requirements ofsubsection (c)(3), including copies ofthe signed certification statement and the verification results obtainedbyboth laboratories; (iii) Records documenting either compliance with the Good Laboratory Practice Standards at 40 CFR Part 792, or use ofa laboratory accredited by the American Industrial Hygiene Association (AlliA) or another comparable program approved in advance in writing byEPA. Where the Company elects to not comply with TSCA GLPS, such records shall include the written accreditation from the AlliA orthe written approval from EPA. (iv) Records documenting all exposure monitoring dates, duration, and results ofeach sample taken; (v) Records documenting the name, address, work shift,job classification, and work33
area ofthe person monitored and ofall other persons whose exposures the monitoring is intended to represent; (vi) Any conditions that might have affected the monitoring results; (vii) Notification ofexposure monitoring results required byparagraph (d)(6); (viii) Records documenting any changes in the production, process, control equipment, personnel or work practices that may reasonably cause new or additional exposures to the PMN substance; (ix) Records documenting any spills, leaks, ruptures or other breakdowns that may
cause new or additional exposure;

substance; (x) The type ofrespiratory protective devices worn by the monitored person, ifany; (xi) Records documenting any actions taken to mitigate exposures to the PMN
(xii) Records documenting reliance on the objective data exemption in paragraph (d)(7), including: (A) the source ofthe data, (B) protocols and results ofanyrelevant testing or analysis, (C) a description ofthe operation exempted and how the data demonstrate that employee exposures will not exceed the action level, (D) other data relevant to the operations, materials and employee exposures covered bythe exemption.

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,34 at a minimum, describe how the requirements ofthis section for labels, MSDSs, and other forms of warning material will be satisfied. The Company must make the written hazard communication program available, upon request, to all employees, contractor employees, and their designated representatives. The Company may rely on an existing hazard communication program, including an existing program establishedunderthe 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 or to a TSCA section 5(a)(2) SNUR at 40 C.F.R. Part 721, subpart E. The list mustbe maintained in each work area where the PMN substance is known to bepresent and must use the identity provided on the MSDS for the substance required under paragraph (c) ofthis section. The list may be compiled for the workplace or for individual work
areas. Ifthe Companyis required eitherbyanother Orderissued under section 5(e) ofTSCA, orby a TSCA section 5(a)(2) SNUR at 40 CFR Part 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 Orderifemployees ofthe35 contractor work 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)( 1 ). (i) The label shall, at a minimum, contain the following information: (I) A statement ofthe health hazards(s) and precautionary measure(s), ifany, identifiedin paragraph (f) ofthis section orbythe Company, for the PMN substance. (IT) The identitybywhich the PMN substance maybe commonlyrecognized. (III) A statement ofthe environmental hazard(s) and precautionary measure(s), ifany, identified in paragraph (f) ofthis section, orbythe Company, for the PMN substance. (IV) A statement ofexposure and precautionary measure(s), ifany, identified in paragraph (f) ofthis section, orby the Company, for the PMN substance. (ii) The Companymay 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 specifiedby subparagraph (b)(I)(i) ofthis section. Any written materials mustbe readily accessible to the employees in their work areas throughout each work shift. (iii) The Companyneed not label portable containers into which the PMN substance is transferred from labeled containers, and which are intended only for the immediate use ofthe employee36 who performs the transfer. (iv) The Company shall not remove or deface an existing label on containers ofthe PMN substance obtained from persons outside the Company unless the container is immediatelyrelabeled with the information specified in subparagraph (b)( 1 )(i) ofthis section. (2) The Company shall ensure that each container ofthe substance leaving its workplace for distribution in commerce is labeled in accordance with this subparagraph (b)(2). (i) The label shall, at a minimum, contain the following information: (I) The information prescribed in subparagraph (b)( 1 )(i) ofthis section. (IT) 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 prominently displayed. ( 4) The label, or alternative forms ofwarning, shall be printed in English; however, the information maybe repeated in other languages. (5) Ifthe label or alternative form ofwarning is to be applied to a mixture containing the PMN substance in combination with any other substance that is either subject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, or defined as a "hazardous chemical" under the Occupational Safety and Health37 Administration (OSHA) Hazard Communication Standard (29 CFR 1900.1200), the Company may prescribe on the label, MSDS, oralternative form ofwarning, the measures to control worker exposure
orenvironmental 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 control measures pursuant to 40 CFR 721.30 before prescribing them underthis subparagraph (b)(5). (6) Ifthe Companybecomes aware ofany significant new information regarding the hazards of the PMN substance or ways to protect against the hazards, this new information must be added to the label within 3 months from the time the 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 SafetyData Sheets. (1) The Company must obtain or develop an MSDS for the PMN substance. (2) The MSDS shall contain, at a minimum, the following information: (i) The identity used on the container label ofthe PMN substance under this section, and, ifnot claimed confidential, the chemical and common name ofthe PMN substance. Ifthe chemical and common name are claimed confidential, a generic chemical name must be used. (ii) Physical and chemical characteristics ofthe substance known to the Company, (e.g., vapor pressure, flash point).38 (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 (t) ofthis section. (v) Signs and symptoms ofexposure, and any medical conditions which are expected to be aggravated byexposure to the PMN substance known to the Company. (vi) Theprimaryroutes ofexposure to the PMN substance. (vii) Precautionary measures to control worker exposure and/orenvironmental release required bythis Order, or alternative control measures which EPA has determined under40CFR 721.30provide substantially the same degree ofprotection as the identified control measures. The MSDS must identify any New Chemical Exposure Limits specified in paragraph (b) ofthe New Chemical Exposure Limit section ofthis Order and must contain the information specified in the graduated respirator table in paragraph (e)(2) ofthe New Chemical Exposure Limit section. (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, workpractices, orpersonal protective equipment. (x) Emergency first aid procedures known to the Company. (xi) The date ofpreparation ofthe MSDS or ofits last revision.39 (xii) The name, address, and telephone number ofthe Company or anotherresponsible party who 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 Company must mark the MSDS to indicate that no applicable information was found. (4) Where multiple 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 Company may prepare one MSDS to apply to all ofthese multiple mixtures. (5) Ifthe Companybecomes aware ofany significant new information regarding the hazards of the PMN substance or ways to protect against the hazards, this new information must be added to the 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 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 Company mayeitherprovide the MSDS with the shipped containers or send it to the personprior to or at the time ofshipment. (7) The Company must maintain a copy ofthe MSDS in its workplace, and must ensure that it is readily accessible during each work shift to employees when they are in their work areas.

### 40 (8) The MSDS may be kept in any form, including as operating procedures, and may be designed to cover groups ofsubstances in a work area where it may be more appropriate to address the potential hazards ofa process ratherthan individual substances. However, in all cases, the required information mustbe provided for the PMN substance and mustbe readily accessible during each work shift to employees when they are in their work areas. (9) The MSDS must be printed in English; however, the information may be repeated in other languages.
(d) Employee Information and Training. The Company must ensure that employees are provided with information and training onthe PMN substance. This information and training must be provided at the time ofeach employee's initial assignment to a work area containing the PMN substance and whenever the PMN substance is introduced into the employee's work area for the first time. (1) The information provided to employees underthis paragraph shall include: (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 programrequired underparagraph (a) ofthis section, including the list ofsubstances required by subparagraph (a)(I) of this section and MSDSs requiredbyparagraph (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 exposure monitoring conducted by the41 Company, continuous monitoring devices, visual appearance, or odor ofthe substance when being released). (ii) The potential human health and environmental hazards ofthe PMN substance as specified in paragraph (f) ofthis section. (iii) The measures employees can take to protect themselves and the environment from the PMN substance, including specific procedures the Company has 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 721.30provide the same degree ofprotection as the specified control measures. (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) Existing Hazard Communication Program. The Company need not take additional actions if existing programs and procedures satisfy the requirements ofthis section.
(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:42 (1) Human health hazard statements. This substance may cause: (i) skin irritation. (ii) respiratory complications. (iii) cancer. (2) Human hazard precautionary statements. When using this substance: (i) avoid skin contact. (ii) avoid breathing the substance. (iii) avoid ingestion. (iv) use respiratoryprotection, ormaintain workplace airborne concentrations at or below an 8-hourtime-weighted average of0.05 mglm3• (v) use skin protection.
(3) 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."

MANUFACTURING (a)(l) Prohibition. The Company shall not cause, encourage, or suggest the manufacture orimport of the 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) ofTSCA43 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 Companyin writing that all Federal Court actions involving the SNUR have been resolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. When EPA promulgates a final SNUR for the PMN substance and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each person whom it causes, encourages or suggests to manufacture orimport the PMN substance ofthe existence ofthe SNUR.

DISTRIBUTION (a) Distribution Requirements. Except after the PMN has been completelyreacted (cured), or as provided in subparagraph (b) the Company shall distribute the PMN substance outside the Company, including for disposal, onlyto a person who has agreed in writing prior to the date ofdistribution, to: (1) Not further distribute the PMN substance to any other person, including for disposal, until after the PMN substance has been completely reacted (cured). (2) Comply with the same requirements and restrictions, ifany, required ofthe Companyin the Protection in the Workplace and the New Chemical Exposure Limit sections ofthis Order. (3) Comply with the same requirements and restrictions, ifany, required ofthe Companyin the Hazard Communication Program section ofthis Order. (b) Temporary Transport and Storage. Notwithstanding paragraph (a), the Company may distribute the PMN substance outside the Companyfor temporary transport and storage in sealed containers44 (labeled in accordance with paragraph (b)(2) ofthe Hazard Communication Program section ofthis Order) provided the following two conditions are met: (1) Subsequent to any such exempttemporary transport or storage ofsealed containers, the PMN substance may be distributed only to the Company or a person who has given the Companythe written agreement required byparagraph (a). (2) Any human exposure orenvironmental release resulting from opening the sealed containers and removing or washing out the PMN substance may occur only while the PMN substance is in the possession and control ofthe Company or a person who has given the Company the written agreement required byparagraph (a).
(c) 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 (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.45 (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, oris aware ofthe terms 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, or has 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 expire 75 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 seekingjudicialreview ofthe SNUR. Ifthe Company is so notified, paragraph (a)(l) ofthis Distribution section shall not expire until EPAnotifies the Companyin writing that all Federal Court actions involving the SNUR have been resolved and the validity ofthe SNUR affirmed. (2) When EPA promulgates a final SNUR for the PMN substance and paragraph (a)(l) ofthis Distribution section expires in accordance with subparagraph (d)(l), the Company shall notify each46 person to whomit distributes the PMN substance ofthe existence ofthe SNUR. Such notification must be in 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. Suchnotice 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 (a)(l), such notice may substitute for the written agreement required in the introductory clause ofparagraph (a); so that, ifthe Companyprovides such notice to the persons to whomit distributes the PMN substance, then the Company is not required to obtain from such persons the written agreement specified in paragraph (a).



### 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 orbatches ofthe PMN substance eligible for the export only exemption in Section I, Paragraph (b)(3) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, copies of the export label and export notice to EPA, required by TSCA sections 12(a)(l)(B) and 12(b),47 respectively. Any amounts orbatches ofthe PMN substance eligible for the research and development exemption in Section I, Paragraph (b)(4) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records required by 40 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 in paragraphs (2) and (3) below, but is exempt from the other recordkeeping 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, 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; ( 4) Records documenting the address, ofall sites ofmanufacture, import, processing, and use; (5) 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; (6) Records documenting the determinations required by the Protection in the Workplace section ofthis Order that chemical protective clothing is impervious to the PMN substance; (7) Records required by paragraph (f). ofthe New Chemical Exposure Limits section ofthis

### 48 Order, ifapplicable; (8) Records documenting establishment and implementation ofthe hazard communication program required by the Hazard Communication Program section ofthis Order; (9) Copies oflabels required under the Hazard Communication Program section ofthis Order; ( 1

0) Copies ofmaterial safety data sheets required by the Hazard Communication Program section ofthis Order; (11) 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 ofthis Order; (12) Records documenting compliance with any applicable disposal requirements under the Disposal section ofthis Order, including method ofdisposal, location ofdisposal sites, dates of disposal, and volume ofPMN substance disposed. Where the estimated disposal volume is not known to the Company and is not reasonably ascertainable by the Company, the Company must maintain otherrecords which demonstrate establishment and implementation ofa program that ensures compliance with any applicable disposal requirements; (13) Records documenting establishment and implementation ofprocedures that ensure compliance with any applicable water discharge limitation in the Release to Water section ofthis Order; (14) Copies ofany Transfer Documents and notices required by the SuccessorLiability section ofthis Order, ifapplicable; and (15) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substance is manufactured orimported.

### 49
(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 CFR Part 1320, particularly 5 CFR 1320.5(b), the Companyis 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. REQUESTS FORPRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section 11 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 may be written or oral. The types ofinformation that EPA mayrequest may 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;

### 50 (ii) Current workshift schedules for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; (iii) Currentjob titles orcategories for workers who are involved in activities associated with the PMN substance and mayreasonablybe exposed to the PMN substance; (iv) Existing exposure monitoring data for workers who are involved in activities associated with

·the PMN substance and mayreasonablybe exposed to the PMN substance; (v) Records required bythe Recordkeeping section ofthis Order; and/or (vi) Any otherinformation reasonablyrelated to determining compliance with this Order or conducting an inspection for that purpose.
(b) Company's Response. The Company shall respond to such requests within a reasonable period of time, but in no event later than 30 days after receiving EPA's request. When requested in writing by EPA, the Company's response shall be in writing. To the extent the information is known to or .reasonably ascertainable by the Company at the time 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 ofTSCA and 40 CFR Part 2.51 

### V. SUCCESSORLIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures bywhich the Company's rights and obligations under this Ordermay be transferred when the Companytransfers its interests in the PMN subst;mce, including the right to manufacture the PMN substance, to anotherperson 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 orimport ("NOC") for the PMN substance from the Companypursuant to 40 CFR 720.102, the Successorin Interest must submit a
new PMN to EPA and comply fully with Section 5(a)(l) ofTSCA and 40 CFR part 720before commencing manufacture orimport ofthe PMN substance. (2) AfterNOC. Ifthe transfer from the Company to the Successorin Interest is effective after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and shall not be required to submit a new PMN to EPA
(c) Definitions. The following definitions apply to this SuccessorLiability section ofthe Order: (1) "Successor in Interest" means a person outside the Companywho 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 of52 the Company in 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, ordoing business in the United States in accordance with 40 CPR 720.22(a)(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 Company to 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, by registered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, by registered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document must be maintained bythe 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 inspection pursuant to Section 11 ofTSCA, must state the effective date oftransfer, and must contain

### 53 provisions which expresslytransferliability 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 ofthe transfer described above. (2) The Successorin Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date oftransfer. (3) Nothing in this section shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, oromissions 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 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 bythe Companyup to the date oftransfer shall count towards the test trigger applicable to the Successorin Interest.

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company may petition EPA at any time, based upon new information on the human health

### 54
orenvironmental effects of, orhuman exposure to orenvironmental 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 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 orother information that supports the findings in this Order, an examination ofnew test data or otherinformation or analysis, and any otherrelevant information. EPAwill issue a modification orrevocation ifEPA determines that the activities proposed therein will not present an unreasonable risk ofinjury to 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 ofthe PMN substance. In addition, the Company may petition EPA at any time to make othermodifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.

### 55 VII. EFFECT OF CONSENT ORDER By consenting 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 Order no later than 45 days before the end ofthe review periodpursuant to section S(e)(l)(B) ofTSCA, and to challenge the validity ofthis Orderin any subsequent action. Consenting to the entry ofthis Order, and agreeing to beboundbyits terms, do not constitute an admission by the Company as to the facts orconclusions underlying the Agency's determinations in this proceeding. This waiver does not affect any otherrights that the Company may have underTSCA.



# /6- ;:;z- oc? Date i 

### Chemical Control Division Office ofPollution Prevention and Taxies

Company: Arch Chemicals, Inc.

### ATTACHMENT A DEFINITIONS [Note: The attached Ordermaynotcontain some of the terms defined below.] "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed bythe 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 barrierto 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 orany mixture containing the chemical substance in a commercial enterprise providing saleable goods ora service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Common name" means anydesignation oridentification such as code name, code number, trade name, brand name, orgeneric chemical name used to identify a chemical substance otherthanby its chemical name. "Consumer" means a private individual who uses a chemical substance or any product containingthe chemical substance in or around a permanent ortemporary household orresidence, during recreation, or for anypersonal 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 underthe conditions specified in Part II. ofthis Consent Order and in the Consent Orderfor ContractManufacturer.2 "Identity" means anychemical orcommon name used to identify a chemical substance or a mixture containingthat substance. "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is underthe control of, and used onlyby, the person who transferred it from a labeledcontainer and will onlybe used bythat 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 underthe conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, ordisposal 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-enclosed process" means anyequipment system (such as an open-topreactor, storage tank, ormixing vessel) in which a chemical substance is manufactured, processed, orotherwise used where significant direct contact ofthe bulkchemical substance and the workplace airmay 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 submittedbythe Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on thebodyto 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, orequivalent 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

### 3 GoodLaboratory Practice Standards at 40CFR Part 792 without prior or subsequent Agency approval that prevents areasoned evaluation ofthe health orenvironmental effects ofthe PMN substance. "Scientificallyequivocal data" means data which, although developed in apparent conformity with the GoodLaboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation ofthe potential risk of injury to human health orthe environment ofthe PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for longterm 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, ordisposal 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 a room ordefined 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.ATTACHMENTB STATISTICAL ANALYSIS OF NCELs ANALYTICAL METHOD VERIFICATION RESULTS This Attachment describes the statistical technique (with examples) for comparing the analytical results obtainedby two laboratories pursuant to paragraph (c)(3)(vii) ofthe New Chemical Exposure Limit section ofthis Order. STATISTICALTECHNIQUE To obtain two-sample t test with unequal variances, perform the following operations:
• Compute means ofthe data measured bytwo laboratories.
• Compute mean squares

• Formthe ratio

• Compute degrees offreedom

where,

X 1 = Average ofthe results from the company laboratory X2 = Average ofthe results from the independent laboratory
n1 =Number ofsamples analyzed bythe company laboratory
n2 =Numberofsamples analyzed bythe independent laboratory.2 Then compare the absolute value ofTto the 97.5 percentilepoint ofa t distribution with f degrees offreedom. Ifthe absolute value exceedsthe 97.5 percentile point, the results measuredby two laboratories are significantly different at 95% level. Otherwise, they are not significantlydifferent. In general, f may not be a integer. Use interpolation to obtain the 97.5 percentile point ofat distribution with f degrees offreedom.

EXAMPLES

-- The following examples (based on simulated data) illustrate the method: Example 1

X 1

## =83.30 n 1

## =6 Data Set 1 80.56 100.01

86.04 52.61 84.85 95.75



### S 1 1 = 278.72 

## w 1 = 46.25 Absolute value ofT

# = 2.467 

### X2 = 100.40 

## Sl = 9.26 f 

## =5.33 Data Set 2 97.11 102.13

99.83 97.83 105.44 100.04
n2 = 6

The t table shows that the 97.5 percentilepoint is 2.571 and 2.447 for 5 and 6 degrees of freedom, respectively. For5.33 degrees offreedom, the 97.5 percentile point will be approximately 2.530 which is greater than the absolute value ofT, 2.467. Hence, the means oftwo data sets are not significantlydifferent at the 5% level. However, ifthis problemhad been treated as an ordinarytwo-sample t test, the means wouldbe significantly different at the 5% level because the absolute ofTis greaterthan 2.228, the 97.5 percentile point for the t distribution with 10 degrees offreedom. Example 2 Data Set 1 82.87 101.85

87.44 Data Set2 108.05

96.51 100.0499.68 101.15 99.21

Absolute value ofT =**2.2~.54** 

### 3

104.37 S/= 27.25 104.33 110.32 107.00

The t table shows that for 8 and 9 degrees offreedom the 97.5 percentile pointis 2.306 and 2.262, respectively. For 8.54 degrees offreedom the 97.5 percentile point will be approximately 2.282 which is less than the absolute value ofT, 2.290. Hence, the means oftwo data sets are significantly different at the 5% level.Company (Transferor) ATTACHMENT C NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(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 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 or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successorin Interest. Successorin Interest also certifies that it is incorporated, licensed, ordoing business in the United States in accordance with 40 CFR 720.22(a)(3).
3. Confidential Business Information. The Successorin Interest hereby:

_ reasserts,

_ relinquishes, or modifies all Confidential Business Information (CBI) claims made bythe Company, pursuant to Section 14 of TSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is indicated, such modification shall be explained in detail in an attachment to this Notice ofTransfer. Information which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBIbythe original submitter) would not subsequentlybe eligible for confidential treatment under this Notice of Transfer.

### 2 TOXIC SUBSTANCES CONTROLACT SECTION 5(e) CONSENT ORDER NOTICE OFTRANSFER (continued) Company (Transferor) PMNNumber
Signature ofAuthorized OfficiaDate
Printed Narne ofAuthorized Official
Title ofAuthorized Official



### Successor inInterest
Signature ofAuthorized OfficiaDate
Printed Name ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code

### TOXIC SUBSTANCES CONTROLACT SECTION5(e) CONSENT ORDER NOTICE OFTRANSFER (continued)

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