UNITED STATES ENVIRONMENTALPROTECTION AGENCY

In the matter of:

Kior, Inc. OFFICE OF POLLUTION PREVENTION AND TOXICS REGULATION OF A NEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT OFINFORMATION

) ) ) ) ) 

### ) ) ) ) ) ) Premanufacture Notice Number:

P-11-327, P-11-328, P-11-329, P-11-330, P-11-331 and P-11-332

Consent Order and Determinations Supporting Consent Order11 TABLE 

### OF CONTENTS Preamble 1. Introduction II. Summary ofTerms ofthe Order III. Contents ofPMN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health and Environmental Effects
Consent Order I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Recordkeeping IV. Requests for Pre-Inspection Infomlation V. Successor Liability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order Attachment A

- Definitions AttachmentB

- Statistical Analysis ofNCELs Analytical Method Verification Results Attachment C

- Notice ofTransferofConsent Order111 

## PREAMBLE I. INTRODUCTION Under the authority of § 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e», the Environtnental Protection Agency ("EPA" or "theAgency") issues the attached Order, regarding premanufacture notices ("PMN") P-ll-0327, P-ll-0328, P-ll-0329, P-ll0330, P-II-0331 and P-ll-0332 for the chemical substances: Distillates (lignocellulosic), C5-40 (PI 1-0327) , Paraffin waxes (lignocellulosic), C5-40, cyclic and linear (P-ll-0328), Naphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (P-II-0329), Kerosene (lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (P-II-0330), Distillates (lignocellulosic), hydrotreated, C8-26

- branched, cyclic, and linear (pcll-0331) and Residual oils (lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear (P-II-0332) ("the PMN substance") submitted byKior, Inc.("the Company"), to take effect upon expiration ofthe PMNs review period. The Company submitted these PMNs to EPA pursuantto § 5(a)(1) ofTSCA and 40 CFR Part 720. Under § 15 ofTSCA, it is unlawful for anyperson to fail orrefuse to comply with any provision of § 5 or anyorder issued under § 5. Violators maybe subject to various penalties and to both criminal and civil liability pursuant to 

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

### II. SUMMARY OF TERMS OF THE ORDER The Consent Order for these PMN substances requires the Companyto: (a) provide its workers respirators to prevent inhalation exposure; NIOSH Assigned Protection Factor ("APF") of 10,000; (b) as an altemative to using respirators, maintain workplace airborne concentrations ofthese PMN substances at orbelow a specified New Chemical Exposure Limit ("NCEL") of0.32 mg/m3
, v.erified by actual exposure monitoring data (to pursue this option, a sampling and analytical methodmustbe developed by the Company, verified by an independent third-party laboratory, and submitted to EPA); (c) distribute the PMN substance only to a person who agrees to follow the samerestrictions (except the testing requirements); (d) Comply with the Release to Water Provisions; and (e) Maintain certain records.v III. CONTENTS OF PMNs 

### By signing this Order, the Compan"y represents that it has carefully reviewed this document and agrees that all information herein that is claimed as confidential by the Company is correctly identified within brackets and that any information that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA

### will remove only the information contained within thebrackets. Confidential Business Information Claims (Bracketed in the Preamble and Order): Representative Chemical structure, Production volume, Manufacturing sites, and Category ofuse is CBI only for Pll-327 and PIl-328.



### Chemical Identity: P-ll-0327 Specific: Distillates (lignocellulosic), C5-40
Specific: ["

Generic: Distillation feedstock afterhydrotreatment Maximum 12-Month Production Volume: [' yr] 

### Chemicalldentity: P-ll-0328 Specific: Paraffin waxes (lignocellulosic), C5-40, cyclic and linear
Specific: [. Generic: Feedstock Maximum 12-Month Production Volume: [. Iyr]vi 

### Chemical Identity: P-ll-0329 Specific: Naphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear
Specific: Hydrotreated Lignocellulosic Naphtha will be used as blendstock for conventional fossil fuels
Maximum 12-Month Production Volume: [ 

### Chemical Identity: P-ll-0330 Specific: Kerosene (lignocellulosic)" hydrotreated, C8-16-branched, cyclic and linear
Specific: Hydrotreated Lignocellulosic Kerosene will beused as blendstock for conventional fossil fuels. Maximum 12-Month Production Volume: [ 

## __ J Chemical Identity: P-ll-0331 Specific: Distillates (lignocellulosic), hydrotreated, C8-26

- branched, cyclic, and linear
Specific: Hydrotreated Lignocellulosic Distillate will be used as blendstock for conventional fossil fuels Maximnm 12-Month Production Volume: [ 

### ChemicaIIdentity: P-U-0332 Specific: Residual oils (lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear**Sp~cific:** Intended for use in a manner comparable to gas oil as it is currentlyused in industry
Maximum 12-Month Production Volume: [ 

## JVll 

### IV. EPA'S ASSESSMENT OF RISK The following are EPA's predictions regarding the probable human toxicity, human exposure and environmental releases ofthese PMN substances, based on the information currently available to the Agency. Human Health Effects Summary: Absorption: Absorption ofsome (unspecified) PMN constituents is good all routes, based on physical/chemical properties. Toxicological Endpoints ofConcern: There are concerns for solvent irritation and solvent neurotoxicity. There is also concern for dermal and respiratory sensitization, based on styrene and information in the PMN MSDS(s). There are also concerns for immunotoxicitybased on benzene, phenol, styrene and toluene, and mutagenicitybased on phenol, toluene, methyl vinyl ketone, and benzofuran. There is also concern for oncogenicitybased on benzenes.
Basis: Theprimaryhealth concerns for the PMNs havebeen oncogenicity, immunosuppression, and skin sensitization (defatting ofthe skin tissue). These PMNs are complex mixtures and as such havebeen toxicologically assessed based on the toxic components within their mixture that raise issues concerning risk to humanhealth. The most important and primary component present is benzene. Benzene is a known human carcinogep. as well as an agent thathas been shown to cause immunosuppression in humans. The EPA Maximum Contaminate Level (MCL) for benzene in drinking water is 5 ppb. Secondary to benzene there were several other components present that included toluene (methyl-benzene), xylene (Dimethyl benzene (ortho, meta, and para»), ethyl-benzene, and styrene. All ofthese additional components are believed to have a lesserrole in initiating human toxicity than benzene. Thus the focus ofthis liskviii assessment is on benzene. Environmental Effects Summary: Based on Quantitative Structural Activity Relationship ("QSAR") analysis derived from test data on structurally similar neutral organics, See www.epa.gov/opptintr/newchems/pubs/chemcat.htu1 EPA expects toxicity to aquatic organisms in surface waters to occur from these PMN substances at 82 ppb for PII-329 and PI1-331; and 180 ppb for P11-327, PII-328, P 11-330, and PII-332. EPA does not expect risk to aquatic organisms at the expected levels and duration ofexposure as described in the PMNs.
Exposure and Environmental Release Summary: 

### Pll-327 Mannfacture [ :] 

### [l ] 

### [J 

### _1 # Sites 1 I 1 Workers 

### 3 3 3 (#/site) Exposure 365 365 365 (days/year) Dermal Exposure 880 880 880 (mg/day) Inhalation Exposure 4.9 4.9 4.9 (mg/day) Inhalation Dose 3.87E-4 2.73E-3 2.73E-3 (mg/kg/day) Releases (days/year) 0 O· 365 Release to Water 0 0 1.1 (kg/day)IX


### PIl-328 Manufacture Use [. 

### 1 [ [ 

## 1 # Sites I I I I Workers 3 3 3 3 (#/site) Exposure 365 365 365 365 (days/year) Dermal Exposure 1800 880 880 1800 (mg/day)

. Inhalation Exposure 3.9E+2 0.16 0.16 3.9E+2 (mg/day) Inhalation Dose 'S.27E-2 2.65E-3 2.65E-3 8.2E-4 (mg/kg/day) Releases (days/year) 0 0 365 0 Release to Water 0 0 

### 1.1 0 (kg/day)x 

### Pll-329
Manufacture Process 1 Process 2 Use [ I] [ ] [ ] # Sites 2 1 2 235 Workers 12 3 6 705 (#/site) Exposure 365 365 365 365 (days/year) Dermal Exposure 1800 1800 1800 180 (mg/day) Inllalation Exposure 5.05E+5 8600 2.40E+6 4.3e+4 (mg/day) Inhalation Dose 3.90E-2 l.37E-3 3.1OE-l 2,41E-3 (mg/kg/day) Releases (days/year) 365 0 0 0 Release to Water 0.54-1.1 0 0 0 (kg/day)Xl Pll-330 I Manufacture Process 1 Process 2 Use
r r ;] [ # Sites 2 1 2 53 Workers 12 3 3 159 (#/site) Exposure 365 365 365 365 (days/year) Dennal Exposure 1800 1800 1800 . 180 (mg/day) Inhalation Exposure l.1E+5 1800 l.lE+6 4.2E+4

. (mg/day) Inhalation Dose 8.09E-3 2.65E-4. 6.9IE-2 .2.33E-3 (mg/kg/day) Releases (days/year) 365 0 0 0 Release to Water· 0.54-1.1 0 0 

## O. (kg/day)xu Pll-331
Manufacture Process 1 Process 2 Use [ 

## I [ ] r 

## J

- # Sites 2 1 2 185

. Workers 12 3 6 3 (#/site)

. Exposure 365 365 365 365 (days/year) Dermal Exposure 1800 1800 1800 180 (mg/day)

. Inhalation Exposure 3.5E+4 7.5E+2 2.lE+5 3.7E+3 (mg/day) Inhalation Dose 8.82E-3 9.27E-4 2. 13E-2 2.09E-4 (mglkg/day) Releases (days/year) 365 0 0 0 Release to Water 0.54-1.1 0 0 0 (kg/day)Xlll Pll-332
Mannfacture Process 1 Process 2 Use 

## l [ 

## I l J # Sites 2 1 2 53 Workers 3 13 3 159 (#/site) Exposure 365 365 365 365 (days/year) Dennal Exposure 1800 1800 1800 180 (mg/day)

. Inhalation Exposure negligible negligible negligible negligible (mg/day) Inhalation Dose 1.13E-3 2.65E-4 l.30E-5 5.35E-5 (mg/kg/day) Releases (days/year) 0 0

. 0 

### 0 Release to Water 0 0 0 0 . (kg/day)XIV 

### V. EPA'S CONCLUSIONS OF LAW The following findings constitute thebasis ofthe Consent Order: (a) EPA is unable to determine the potential for immunotoxicity, carcinogenicity, and hydrocarbon pneumonia from exposureto these PMN substances. In addition, EPA is unable to determine the potential for chronic toxicity to aquatic organisms from exposures to these PMN substances. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) ofTSCA, that the information available to the Agency is insUfficient to permit a reasoned evaluation ofthe human health and environmental effects ofthe PMN substance.
(b) In light ofthe potential risk ofimmunotoxicity, carcinogenicity, andhydrocarbon pneumonia posed bythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthese PMN substances,EPA has concluded, pursuant to § 5( e)(1)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, impOli, processing, distribution in commerce, Use, and disposal of these PMN substances may present anunreasonable risk ofinjury to human health and the enlvironment.



### VI. INFORMATION REQUIRED TO EVALUATE HEALTH AND ENVIRONMENTAL EFFECTS Pended Testing. The following additional infOlwation on each PMN would berequired to evaluate the following effects which maybe caused bythese PMN substances: Infonnation/Effects Guidelines Combined Chronic Toxicity/Carcinogenicity OPPTS 870.4300Aquatic Inveliebrate Chronictoxicity test, fi'eshwater daphnids (Flow-through conditions/ measured concentrations)

Fish acute toxicity (Flow-through conditions/ measured concentrations) xv OPPTS 850.1300

OPPTS 850.1400

The Order does not require submission ofthe abovepended testing at any specified time or

.production volume. However, the Order's restrictions on manufacture, impOli, processing, distribution in commerce, and usewill remain in effect until the Order is modified orrevoked by EPA based on submission ofthator other relevant information.UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460



## CONSENT ORDER

I. SCOPE OFAPPLICABILITY AND EXEMPTIONS OFFICE OF CHEMICAL SAF'ETY AND POLLUTION PREVENTION

(a) Scope. Therequirements ofthis Order applyto all commercial manufacturing, processing, distIibution in commerce, use and disposal ofthe chemical substances: distillates (lignocellulosic), C5-40 (PI 1-0327); paraffin waxes (lignocellulosic), C5-40, cyclic and linear (P-II-0328); rnaphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (P-I 1- 0329); kerosene (lignocellulosic),hydrotI·eated, C8-16-branched, cyclic and linear (P-I 1-0330); distillates (lignocellulosic), hydrotreated, C8-26 - branched, cyclic, and linear (P-II-0331); and residual oils (lignocellulosic), hydrotI"eated, C20-40- branched, cyclic, and linear (P-l 1-0332) ("the PMN substances") in the United States byKior, Inc.("the Company"), except to the extent that those activities are exempted byparagraph (b).

Internet Address (URl) • http.l/www,epa.gov Recycled/Recyclable' Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper- 2 - (b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthese PMN substances is exempt from the requirements ofthis Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer OfConsent Order sections) only to the extent that (I) 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) Export. Until the Companybegins commercialmanufacture ofthese PMN substances for use in the United States,therequirements ofthis Order do not apply to manufacture, processing ordistribution in commerce ofthese PMN substances solely for export in accordan.ce with TSCA §12(a) and (b), 40 CPR 720.3(s) and 40 CPRPart 707. However,
once the Companybegins to manufacture these PMN substances for use in the United States, no further activity bythe Company involving these PMN substances are exempt as "solely for export" even ifsome amount ofthese PMN substances are later exported. At that point, the requirements ofthis Order apply to all activities associated with these PMN substances while i.n the territory ofthe United States. Priorto leaving U.S. territory, even those quantities orbatches ofthese PMN substances that are destined for export are subject to tenns ofthe Order, and count towards any production volume testtriggers in the Testing section ofthis Order. (2) Research & Development ("R&D"). Therequirements of this Order do not applyto manufacturing, processing, distribution in commerce, use and disposal ofthese PMN substances in small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CPR 720.3(cc), and 40 CPR 720.36. The requirements of this Order also do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthese PMN substances- 3

- when manufactured solely for non-commercial research and development per40 CFR nO.30(i) and TSCA §5(i). (3) Byproducts. The requirements ofthis Order do not apply to these PMN substances when they are produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR nO.3(d) and in compliance with 40 CFR 

### nO.30(g). (4) No Separate Commercial Purpose. The requirements ofthis Order do not apply to these PMN substances when they are manufactured, pursuant to any ofthe exemptions in 40 CFR nO.30(h), with no commercial purpose separate from the substance, mixture, or article of which they are a part. (5) Imported Articles. The requirements ofthis Order do not apply to these PMN substances when they are imported as part ofan "article" as defined at 40 CFR 

### nO.3(c) and in compliance with 40 CFR nO.22(b)(1).
(c) Automatic Sunset. Ifthe Companyhas obtained for these PMN substances a Test Market Exemption ("TME") under TSCA §5(h)(1) and 40 CFR 

### nO.38 or a Low Volume Exemption ("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)(4) and 40 CFR n3.50(c)(1) iilld (2) respectively, any such exemption is automatically rendered null and void as ofthe effective date ofthis Consent Order.- 4

- 

### II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND.DISPOSAL 

### PENDING SUBMISSION AND EVALUATION OF INFORMATION

PROHIBITION The Companyis prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthese PMN substances in the United States, for anynonexempt commercial pm-pose, pending the development ofinformation necessaryfor areasoned evaluation ofthe human health and environmental effects ofthese substances, and the completion ofEPA's review of, and regulatory action based on, that information, except in· accordance with the conditions described inthis 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 or the environment and which is required to be reported under TSCA section 8(e) shall reference the appropriate PMN identification number for this substance and contain a statement that the substance is subject to this Consent Order. Additional infonnation regarding section 8(e) reporting requirements can be found at www.epa.gov/opptitsca8e.
(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA Monitoring Assistance and Media Programs Divison (2227A), Office**ofEnfo~cement** and Compliance- 5 - 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 performedpursuantto this Order, or within 15 days after the effective date ofthis Order, whicheveris later: (1) The date when the study.is scheduledto commence; (2) The name and address ofthe laboratory which will conduct the study;. (3) Thename and telephone number ofa person at the Companyorthe laboratory whom EPA may contactregarding the study; and, (4) The appropriate PMN identificationnumber for each substance and a statement that the substance is subject to this Consent Order.
(c) Good Laboratory Practice Standards and Test Protocols. Each studyrequiredperfomled to address therisk identified in this Ordermustbe conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the relevant scientific community at the time the studyis initiated. Before starting to conduct any studythat will use a modified version ofthepublished test guidelines, the Companymust submit written testprotocols to EPA for review (submission ofwritten test protocols is options for test that are to be conducted using unmodified published test guidelines). Protocols mustbe submitted as a support document for this PMN, usingprocedures set out in 40 CFR 720. EPA will respond to the Company within 4 weeks ofreceiving the written notice (d) Unreasonable Risk. EPA maynotifythe Companyin writing thatEPA finds that the data generated by.a- 6 - study are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substance will ormaypresent an urueasonable risk ofinjury to human health orthe environment. EPA's notice may specifythat the Companyundertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposures to orto better characterize the lisks presentedby the PMN substance. Within 2 weeks from receipt ofsuch a notice, the Companymust cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance, unless either: (1) within 2 weeks from receipt ofthe EPA notice, the Company complies with such requirements as EPA's notice specifies; or (2) within 4 weeks from receipt ofthe EPA notice, the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness ofany additional requirements imposedbyEPA. The Companymay continue to manufacture, import, process, distribute, use and dispose ofthe PMN substance in accordance with the terms ofthis Orderpending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks ofreceipt ofEPA's written response, the Company shall comply with anyrequirements imposedbyEPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthePMN substance,

### - 7 -
PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. During manufacturing, processing, and use ofthese PMN substances at any site controlled bythe Company (including any associated packaging an.d storage and during any cleaning ormaintenance ofequipment associated with these PMN substances), 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 these PMN substances through direct handling ofthe substance or through contact with equipment on which the substance may exist, is provided with, and is required to wear, personal protective equipment thatprovides a barrier to prevent dermal exposure to the substances in the specific work area where it is selected for use. Each such item ofpersonal protective equipment mustbe selected and used in accordance with Occupational Safety and Health Administration ("OSHA") dermal protection requirements at 29 CPR 1910.132,1910.133, and 1910.138. (2) Demonstration ofImperviousness. The Company is able to demonstrate that each item ofchemical protective clothing selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within the work area by anyone 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

likely combinations ofchemical substances to which the'clothing'maybe exposed in the work- 8 -

area. Penneation testing shall be conducted according to the American Society for Testing and Materials ("ASTM") F739 "Standard Test Method for Resistance ofProtective Clothing Materials to Penneation by Liquids or.Gases." Results shall be reported as the cumulative penneation rate as a function oftime, and shall be documented in accordance with ASTM F739 using the fonnat specified in ASTM F1194-99 "Guide for Documenting the Results ofChemical Penneation Testing on Protective Clothing Materials." Gloves maynotbe used for a time period longer than they are actually tested and must bereplaced at the end ofeach work shift during which they are exposed to the PMN substance. (ii) Manufacturer's Specifications. Evaluating the specifications from the manufacturer or supplier ofthe chemical protective clothing, or ofthe material used in construction ofthe clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likely combination with other chemical substances in the work area. (3) Respiratory Protection. Each person who is reasonably likelytobe exposedby inhalation in the work area to these PMN substances is provided with, and is required to wear, at
a minimum, itNational Institute for Occupational Safety and Health ("NIOSH")-celiified respirator with an Applied Protection Factor ("APF") of I0,000, from the respirators listed in subparagraph (a)(4) ofthis section, and the respirator is used in accordance with OSHA and NIOSH respiratory protection requirements at 29 CFR 1910.134 and 42 CFRPart 84. All respirators mustbe issued, used, and maintained according to an appropriate respiratory protection program under the OSHA requirements in 29 CFR 1910.134.- 9 - (4) Authorized Respirators. The following NIOSH-certified respirators meetthe minimum requirements for subparagraph (a)(3) ofthis section: (I) AnyNIOSH-certified pressure-demand or otherpositivepressure mode (e.g. open/closed circuit) self-contained breathing apparatus (SCBA) equipped with a hood
or helmet or full facepiece.
(b) De Minimis Concentrations. The requirements ofthis section do not apply to quantities of these PMN substances that are (1) present in the work area only as a mixture and (2) at a concentration not to exceed 1.0 percentbyweight orvolume (0.1 percent by weight or volume if the PMN substance(s) are identified as a potential carcinogen in paragraph 

### (f) ofthe Hazard Communication Program section ofthis Order). This exemption is not available ifthe Company has reason to believe that, during intended activities, these PMN substances inthemixture may be reconcentrated above the 1.0 or 0.1 percent level, whichever applies. Ifthis Order contains New Chemical Exposure Limits provisions or Release to Waterprovisions that, respectively, specify a NCEL concentration ("TWA") orin-stream concentration ("N") less than the de minimis concentration speCified here, then this de minimis exemption does not apply to those provisions.

### - 10-
NEW CHEMICAL EXPOSURE LIMIT (a) Altemative to Requirements ofRespirator Section. (1) 

### EPA recommends and encourages the use ofpollution prevention, source reduction, engineering controls and work practices, rather than respirators, as a means ofcontrolling inhalation exposures wheneverpracticable. (2) Whenever a person is reasonably likely to be exposed to these PMN substances by inhalation, as an alternative to compliance with the respirator requirements in the Protection in the Workplace section ofthis Order, the Company may comply with the requirements oftj1is New Chemical Exposure Limit section. However, before the Companymay deviate from the respirator requirements in the Protection in the Workplace section ofthis Order, the Company must: (i) submitto EPA a copy ofthe Company's.sampling and analytical methodfor these PMN substances, verified in accordance with subsection (c)(3) ofthis New Chemical Exposure Limit section; (ii) obtain exposure monitoring results inaccordance 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 in paragraph (e)(2) ofthis New Chemical Exposure Limit section bypersons who are reasonably likelyto be exposed to these substances byinhalation. (3) After appropriate respiratory protection has been selected at a workplace based on the results ofactual exposure monitoring conducted in accordance with this New Chemical Exposure- 11 - Limit section, the Company shall not, at that workplace, use the respiratoryprotection relluired in the Protection in the Workplace section ofthis Order (unless it is the same as required bythis New Chemical Exposure Limit section).
(b) Exposure Limit. (1) General. The following new chemicalexposurelimit ("NCEL") for these PMN substances is an interim level determined by EPA based on the limited information available to theAgency at the time ofdevelopment ofthis Order. TheNCEL for these substances are as follows: (i) Time-WeightedAverage ("TWA") Limit. The Company shall ensurethat no person is exposedto an airborne concentration ofthese PMN substances in excess of0.32 mg/m3 (the NCEL) as an 8-hourtime-weighted average, withoutusing a respirator in accordance with subsection (e) ofthis New Chemical Exposure Limit section. (ii) Non-8-HourWork-shifts. Fornon-8-hour work-shifts, the NCEL for that work-shift (NCELn) shall be determinedb'y the following equation: NCELn = NCELx (Sin) x

.[(24-n)1l6], where n = the number ofhours in the actual work-shift. (2) Automatic Sunset. If, subsequent to the effective date ofthis Order, OSHA promulgates, pursuant to §6 ofthe Occupational Safety and Health Act, 29 U.S.c. 655, a final chemical-specificpermissible exposure limit ("PEL") specifically applicable to these PMN substances and the OSHA PEL is not challenged in court within 60 days ofits promulgation, then anyrespirator requirements in the Protection in the Workplace section ofthis Order.and any**r,~quirements** ofthis New Chemical Exposure Limit section applicable to workers and situations- 12 - subjectto the OSHA PEL shall automaticallybecome null and void. However, the requirements ofthis Consent Order are not negatedby anypre-existing OSHA PEL applicable to these PMN substances.
(c) Performance-Criteria for Sampling and Analytical Method. (I) Applicability. Forinitial development and validation ofthe sampling and analytical method for these PMN substances, all the requirements ofthis subsection (c) apply. For subsequent exposure monitoring conducted pursuant to subsection (d) ofthis New Chemical ExposureLimit section, onlythe following requirements apply: (c)( 4)(i), (4)(ii), (4)(iv)(B), (4)(v)(B), (8), (9), and (l0). Any deviation from the requirements ofthis subsection (c) mustbe approved in writingbyEPA. (2) Submission ofVerified Method and Certification Statement. The Company shall submit to EPA a copy ofa validated sampling and analytical method for these PMN substances 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 mustinclude a written statement, signed by authorized 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:**""-N~C=E=L",-",S-",am=p",li",n,.,.gcea""nd"--,-A!oOn",a,"-lyt,-=ic",al=-=M,,,e,,,th""o""d=--:D""o"'-r--"P-"-MN""'-'--'#'--**__ ," after which the correct PMN numbersfor these chemical substances shall be stated. (3) Verification ofAnalytical Method by Independent Third-Party Laboratory.- 13

- (i) Verification. The Company shall have an independent reference laboratory ("Laboratory") velifythe validity ofthe analytical method for these PMN substanc.es, in accordance with the otherrequirements in this subsection (c)(3). Itis the Company's responsibilityto ensure that the Laboratory complies with all the requirements specified in this subsection (c)(3). (ii) Independent Reference Laboratory. The independentreference laboratory mustbe a separate and distinct person (as defined at 40 CFR 

### nO.3(x» £i'om the Company and from any other person whomay have developed the method for the Company. (iii) Accreditation. The Laboratory mustbe accredited bya formallyrecognized govermnentorprivate laboratory accreditation program for chemical testing and/or analysis. (ivy Good Laboratory Practice Standards. The Laboratory verification ofthe

. analytical method for these PMN substances must comply with TSCA Good LaboratoryPractice

Standards ("GLPS") at 40 CFR Part 792. (Certainprovisions ofthe TSCA GLPS applicable to toxicity testing in laboratory animals, such as 40 CFR 792.43 ("Test system care facilities"), 792.45 ("Test system supply facilities") and 792.90 ("Animal and other test system care"), are clearly inapplicableto the NCEL requirements.) However, compliance with TSCA GLPS is not required underthis New ChemicalExposure Limit section where the analytical method is verified by a laboratory accredited byeither: (A) the American Industdal Hygiene Association ("AIHA") Industrial Hygiene Laboratory Accreditation Program ("IHLAP"); or (B) another comparable program approved in advance in writingby EPA. (v) Analysis ofDuplicate Samples. The Company shall collect six duplicate samples (a total of 12 per PMN)aUheTWA concentration, The samples shall betaken either- 14

- from a conh'olled environment (e.g., a sealed chamber or "glovebox") 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, at 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 analyzedbythe Laboratory using themethod developedby or for the Company. (vi) Sample Storage Study. Ifthe results ofthe analysis ofduplicate samples pursuantto paragraph (c)(3)(v) do not satisfy the requirements inparagraph (c)(3)(vii), the Companymustperform a sample storage study as follows: (1) Triplicate Samples. The Company shall collect six triplicate samples (atotal of 18 per PMN) at the TWA concentration. The samples shall be taken either from a controlled environment (e.g., a sealed chamber or "glovebox") which closelyresembles the actual workplace conditions or, for solids and liquids with very low vaporpressure, byinjecting the PMN substance onto a sample collectiondevice. The triplicate samples shall be collected on identical collection media, at the same time, and under the same conditions. One set ofsix samples shall immediatelybe analyzed bythe Company. (II) Analysis After Sample Storage. A sample storage evaluation shall be perfoffiled with the two remaining sets ofsix samples. One set ofsix samples shall be analyzed bythe Laboratory using the method developed by or for the Company, and the other shall be analyzed bythe Company on the same dayas 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- 15

- conditions must be specified in the method description. (vii) Comparison ofResults. The difference between the results ofthe two sets ofsix samples analyzed bythe Laboratory and the Company as required in eitherparagraph (c)(3)(v) or (c)(3)(vi)(II) shall be evaluated using a two-sample t-test with unequal variances, and the two sides ofthe critical regions shall not exceed a 5% significance level. (See Attachment B

- Statistical Analysis ofNCELs Analytical Method Verification Results.) The arithmetic mean ofeach set ofsix samples mustbe within 10% ofthe overall arithmetic mean ofthe two sets of samplemeasurements. Ifthe arithmetic mean ofeach set ofsix samples is notwithin 10% ofthe overall arithmetic mean, then the sample storage timebetween collection and analysis must be reduced until the average ofeach set ofsix samples is within 10% ofthe overall arithmetic.mean. (4) Accuracy. The sampling and analytical methodmust clearlydemonstrate the following: (i) General. The san1pling and analytical method, and all exposure monitoring datarelied onbythe Company, shall be accurate to within ±25% at a 95% confidence level for concentrations ofthese PMN substances ranging from one halftheNCEL to twicetheNCEL. (ii) NCEL QU311titation Limits. The analytical method should be capable of reliably qU3l1tifying these PMN substances across the full range ofreasonably likely exposures. At a minimum, the analytical method mustbe capable ofreliably quantifying from a lower quantitation limit ("LQL") ofonehalfthe NCEL to an upper quantitation limit ("UQL") ofat least twice the NCEL. Ifthe Company obtains an exposuremonitoring sample thatis more than 10% above the actual UQL ofthe analytical method, the Comp3l1Y must comply with paragraph ",:-,

-- 16

- (iii) Lower Quantitation Limit Signal-To-NoiseRatio. The analytical method shall be capable ofquantifYing these PMNs to a concentration ofonehalfthe NCEL with a signal that is at least five times thebaseline noise leyel. Baseline noise mustbe amplified to a measurable level when possible, even ifthe required amplification is beyond that used in routine analysis ofsamples. (Ifbaseline noise cannot be obtained, another reference mustbe selected. This maybe a peak considered to benoise caused bythe reagentmatrix.) The sampling preparation method must be specified and the detection limit for the analytical proceduremustbe ,reported as mass per injection 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

# alinear correlation of0.95

-- these five (5) calibration standards must consist ofone standard at each ofthe following concentrations: onehalfthe NCEL (0.5 x NCEL); between one halfand one times the NCEL(0.5 x NCEL < > 1 x NCEL); onetimes the NCEL (1 x NCEL); between one and two times the NCEL (1 x NCEL < > 2 x NCEL), and twice theNCEL (2 x NCEL): (II) 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 per every 10 samples analyzed. The continuing calibration sample shall fall within

### ±25% ofthe initial calibration value. Ifnot, then the initial calibration mustbeTepeated,;,- 17

- and any samples associated with that outlying calibration check must bere-analyzed. (v) Calculated Percent Recovery. (I) Initial Calculation. For method development and validation, the Companymustcalculate the percent ofthe PMN substance recovered bythe analytical method from a sample containing aknown quantityofthese PMN substances. The sample 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 verylow vapor pressure, 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 or equal to 125%. Spike concentrations for the PMN substance mustbe included in the sampling and analytical method submitted to EPA. (II)
.Subsequent Calculation. During each subsequent exposure monitoring episode or campaign, at least I matrix spike, prepared by injecting these PMN substances onto a sample collection device, shall be analyzed. (This matrix spike must be prepared at the NCEL concentration.) (vi) Sampling Device Capacity. The capacity ofthe sampling device must be tested and results reported to showunder a known and well-defined set ofconditions that the device is capable ofcollecting the new chemical in solid, liquid or vaporphase with minimal loss. The sampling device's capacity (air volume and collected analyte mass) mustbe specified. For methods that use adsorbenttubes as the collection medium, evidence ofthe capacity must be provided in the form ofbreakthrough testing. This testing must be done at a concentration twice the NCEL and under conditions .similar to thosee,xpected in the workplace. Breakthrough is .:' .- 18

- defined to have occurred when the concentration ofthese PMN substances in the effluent stream is equal to S% ofthe concentration ofthe influent stream, or when 20% ofthe PMN substance is detected in the backup section ofthe sampler. (vii) Sampling Device Desorption Efficiency. Where applicable, the desorption efficiencymustbe evaluated for the air sampling device. A minimum ofsix air samples spiked with the PMN substance at least the NCEL concenh'ation must beprepared. A recovery ofat least 7S% must be obtained for each ofthe six samples. 

### (S) 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» mustbe less than 0.1 OS, including allowance ofO.OS 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% orthe estimated precision is greater than 0.105, then the CompanymustTe-prepare the matrix spike, re-sample, and re-analyze all samples associated with such matrix spike or triplicate samples. (ii) Forpercent recoveries less than 90% but greater than 7S%, correction for low recovery is reql,lired. Correct for recovery fiTst by dividing the observed amount bythe proportion recovered before determining ifmeasurements fall below the NCEL. For example, if the observed level is 30 mg/m3 and the percent recovery is 75%, use the value 30 mg/m3/(0.75) = 40 mg/m3when determining whether the levels are below the exposure limit. (7) Representativeness. All sample conditions used to develop the methodology shall .)1llmic the actual workplace environment expected to bemonitored
..Conditions such as the- 19

- temperature, humidity, lighting, and presence ofother chemicals, etc. mustmimic the conditions in the workplace to be monitored. (8) Changes Affecting Validity. lfthe workplace environment changes from the initial conditions described in the verified sampling and analytical method in a wayreasonably likely to invalidate the accuracy ofthe method, then the Company must comply with the respirator requirements in the Protection in the Workplace section ofthis Order, unless the Company revalidates the method to confirm that therequirements 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(s) to theworkplace which mayinterfere with the analysis ofthese
new chemicals; introduction oflight to the workplace which may interfere with a light-sensitive PMN substance(s); or introduction ofwater/increased humidityto the workplace which could react with the PMN substance(s) and cause difficulties in collection and analysis. (9) Comparability. All data and results shall bereported in the same units ofmeasurement
as the NCEL. (10) Responsibility for Method Validity. The independent laboratory verification and EPA receipt ofthe sampling and analyticalmethod pursuant to this subsection (c) do not ensure that the method will produce valid exposure monitoring data. The Company is ultimatelyresponsible for ensuring the validity ofits exposure monitoring data.
(d) Monitoring Potential Exposure. (l) General. (i) ActionLevel.
.The "action level" is defined as an airborne concelltrationofthe- 20-
PMN substance(s), calculated as an 8-hour time-weighted average, equal to one halfthe NCEL TWA specified in subparagraph (b)(1). For non-8-hout 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 solelyto detennine the requisite monitoring frequency. (ii) Representative Exposure Groups. Whenever exposure monitoring is required bythis New Chemical Exposure Limit section, the Company shall take representative samples of what the potential exposure ofeach person who is reasonably likely to be exposed to airborne concentrations ofthe PMN substance(s) 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 ofevery person perfonning the same or substantially similar operations in each work shift, in eachjob classification, in each work area (hereinafter identified as
an "exposure group") where inhalation exposure to these PMN substances are reasonably likelyto
occur. The exposure ofeach person need not be itselfdirectly sampled ifthat exposure is represented by sampling the exposure ofanotller person in fue same exposure group. (iii) Good Laboratory Practice Standards. Detenninations 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 40 CPR 792.43 ("Test system care facilities"), 792.45 ("Test system supply facilities") and 792.90 ("Animal and other test system care"), are clearly inapplicable to the NCELrequirements.} However, compliance with TSCA GLPS is not required·.- 21 - where exposure monitoring samples are analyzed by a laboratory accredited by either: (A) the American Industrial Hygiene Association ("AIHA") Industrial Hygiene LaboratoryAccreditation Program ("IHLAP"); or (B) another comparable program approved in advance in writing by EPA. (iv) Full Shift Exposure Samples. Representative 8-hourTWA airborne concentrations shall be determined on thebasis ofsamples representing the full shift exposure for each exposure group. (2) Initial Monitoring. Before the Company may deviate from the respirator requirements ofthe Protection in the Workplace section, the Company shall conduct initial exposure monitoring to accurately determine the airborne concentration ofthese PMN substances for each exposure group in which persons are reasonably likely to be exposed to these PMN substances. (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 or below the TWA, the Company shall repeat the exposure monitoring for that exposure group at least every 6 months. Ifthese PMN substances are not manufactured, processed, orused.at all during a given 6 month calendar period, the Company is not required to conduct exposure monitoring until manufacture, processing, or use ofthese PMN substances are resumed. However, cessation ofmanufacturing, processing and use ofthese PMN substances for less than the 6 month period does not constitute grounds for postponement ofthe 6 month deadline to conduct exposure monitoring. (ii) Ifanyrepresentative 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. IfthesePMN substances are not- 22- manufactured, processed, orused at all during a given 3 month calendarperiod, the Companyis not required to conduct exposure monitoring until manufacture, processing, or use ofthese PMN substances is resumed. However, cessation ofmanufacturing, processing and use ofthese PMN substances for less than the 3 monthperiod 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 these PMN substances are 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 ofMonitOling. (i) Ifrepresentative samples taken during the initial exposure monitoring reveal an airbome concentrationbelow the action level, the Companymay discontinue monitoring for that exposure group, except when additional exposure monitoring is required byparagraph (d)(5) of this New Chemical Exposure Limit section. (ii) Ifrepresentative samples taken during the periodic monitoringreveal that an airbome concentration, as indicatedby 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 byparagraph (d)(5) ofthis New Chemical ExposureLimitsection. Where these PMN substances are manufactured;.processed, or.used in- 23

- batches ofduration less than 7 days, the 2 consecutive measurements maybe taken at least 24 hours apart, provided that the measurements accurately reflect the highestpeak exposures and variability in exposure.
(5) Additional Monitoring. (i) For a previously monitored exposure group, the Company shall, within 7 days ofany ofthe events listed below in this paragraph (d)(5)(i), conduct the initial exposure monitoring followed by anyperiodic 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 work practices that may reasonably cause new or additional exposures to these PMN substances; (II) spills, leaks, ruptures or otherbreakdowns occur that mayreasonably
cause new or additional exposures to these PMN substances; and, (III) whenever else the Companyhas any reason to suspect a change that mayreasonably result in new or additional exposures to these PMN substances. (ii) In no event is the additional exposure monitoring requirement in paragraph (d)(5)(i) intended to delay implementation ofany necessary cleanup or otherremedial 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, or more protective respiratory equipment deem?c!appropriateby the best professionaljudgment ofa qualified.expeq.- 24- (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 by that monitoring. The notice shall identify the NCEL, the exposure monitoring results, and any corresponding respiratory protectionrequired by subsection (e). Affected persons shall be notified in writing either individually or byposting the infonnation in an appropriate and accessible location. (ii) Whenever the NCEL is exceeded, the written notification required bythe preceding paragraph shall describe the action being taken bythe Companyto reduce inhalation exposure to orbelow the NCEL, or sha.ll referto a document available to the person which states the actions to betaken to reduce exposure. (7) Exemption based on Objective Data. Where the Company has documented an.d reliable objective data demonstrating that, even under 'worst-case conditions, employee exposure to these PMN substances will not exceed the action level (defined in paragraph (d)(J)(i)) under the expected handling procedures and conditions for a specific "exposure group" (defined in paragraph (d)(l)(ii)), then that exposure group is exemptfrom this New Chemical Exposure Limit section (except paragraph(d)(5) "Additional Monitoring" and subsection(f) "NCELRecordkeeping") and the respirator requirements in the Protection in the Workplace section ofthis Order. Any such objective data must accurately characterize actual employee exposures to these PMN substances 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 substances. Examples ofobjective data that maybe used to demonstrate- 25

- that employee exposure will not exceed the action level, even under worst case conditions, include infonnation on thephysical and chemical properties ofthe PMN substances, industry-wide studies, and/or laboratory test results.
(e) Respiratory Protection. (1) General. Whenever the Companyhas conducted exposure monitoring at a workplace in'accordance with subsection (d)ofthis New Chemical Exposure Limit section and the measured airborne concentration ofthee PMN substances for any person who is reasonably likely tobe exposed to these PMN substances byinhalation exceeds the NCEL,the Company shall provide those persons the respirators specified in this subsection (e) (rather than the respirator(s) identified in the Protection in theWorkplace 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 CPR 1910.134 and 42 CPR Part 84. When the Company has not yet measured the airborne concentration ofthe PMN substances at a workplace in accordance with this New Chemical Exposure Limit section, the Company shall complywith the respirator requirements in the Protection in theWorkplace section ofthis Order at that workplace. (2) Selection ofAppropriate Respiratory Protection. After the Companyhas conducted exposure monitoring in accordance with subsection (d) ofthis New Chemical Exposure Limit section, the Company shall select, provide, and ensurethat persons who are reasonably likelyto be exposed to these PMN substances by inhalation use, at a minimum, the respiratory protection which corresponds in the following table to the measured airborne concentration (ora more

...motective respirator which corresponds to a concentrationhight;J;than measured).Measured Concentration ofPMN Substance
::: NCEL

< 10 x NCEL

::: 25 x NCEL 

### - 16-
GASIVAPOR RESPIRATOR TABLE Required Respiratory Protection

No respiratoryprotection is required. If Data on Cartridge Service Lite Testing has been ReviewedandApproved bvEPA: (I) AnyNIOSH-certified powered air-purifying respirator with a hood or helmet equipped with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges. (II) Any NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. If

No Cartridge ServiceLite Testing has been Conducted: (I) AnyNIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, or helmet. If Data on Cartridge Service Life Testing has been ReviewedandApproved byEPA: (I) AnyNIOSH-certified powered air-purifyingrespirator with a hood or helmet equipped with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges. (II) AnyNIOSH-certified powered air-purifying respirator equipped with a loose fitting facepiece with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges. (III) Any NIOSH-certified continuous flow supplied-air respirator equipped with a hood orhelmet. (IV) Any NIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece.::: 50 

### x NCEL

< 1000 x 

### NCEL lfNo Cartridge Service Life Testing has been Conducted: (I) AnyNIOSH-certified continuous flow supplied-air respirator equipped with a loose fitting facepiece, hood, orhelmet. (II) Any NIOSH-certified negative pressure (demand) supplied-air respirator equipped with a full facepiece. 

### If

Data on Cartridge Service Life Testing has been ReviewedandApproved byEPA: (I) AnyNIOSH-certified air-purifying full facepiece respirator equipped with appropriate gas/vapor cartridges or canisters (acid gas, organicvapor, or substance specific). (II) AnyNIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece (halfor full facepiece) and appropliate gas/vapor eartridges or canisters (acid gas, organic vapor, or substance specific). (III) AnyNIOSH-certified negativepressure (demand) supplied-air respirator equipped with a full facepiece.

(IV) Any NIOSH-certified negativepressure (demand) self-contained breathiug apparatus (SCBA) equipped with a hood, helmet, or a full facepiece. lfNo Cartridge Service Life Testing has been Conducted: (I) AnyNIOSH-certified negativepressure (demand) supplied-air respirator equipped with a full facepiece, (II) Any NIOSH-certified negativepressure (demand) self-contained breathing apparatus (SCBA) equipped with a hood, helmet, or a full facepiece. 

### If

Data on Cartridge Service Life Testing has been ReviewedandApproved by EPA:
. (I) AnyNIOSH-certified powered air purifying full facepiece respirator equipped with appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartJidges.> 1000 x NCEL 

### (max. 10,000 

### x NCEL) - 28

- (II) AnyNIOSH-certified powered air-purifyingrespirator equipped with a hood orhelmet and appropriate gas/vapor (acid gas, organic vapor, or substance specific) cartridges with evidence demonstratingprotection level of ],000 orgreater. (III) AnyNlOSH-certified continuous flow supplied-airrespirator equipped with a full facepiece. (IV) AnyNlOSH-certified continuous flow supplied-airrespirator equipped with a hood or helmet with evidence demonstratingprotection level of I, 000 orgreater. 

## * (VI) AnyNlOSH-certifiedpressure-demand or otherpositivepressuremode supplied-air respirator equipped with a full facepiece. 

### If

No Cartridge ServiceLife Testing has been Conducted: (I) AnyNIOSH-certified continuous flow supplied-airrespirator equipped with a full facepiece. (II) AnyNIOSH-certified continuous flow supplied-air respirator equipped with a hood orhelmet with evidence demonstratingprotection level of 1,000 orgreater. (III) AnyNlOSH-certified pressure-demand or otherpositivepressuremode supplied-air respirator equipped with afull facepiece; AnyNlOSH-certifiedpressure-demand or other positivepressure mode (e.g., open/closed circuit) self-contained breathing apparatus (SCBA) equipped with a hood orhelmet or a full facepiece. 

### * OSHA has assigned APFs of 1000 for certain types ofhoods and helmets with powered air purifying respirators (PAPRs) or supplied air respirators (SARs) where the manufacturer can demonstrate adequate air flows to maintain positive pressure inside the hood or helmet in normal working conditions. However, the employer musfhave evidence provided bythe respirator manufacturer that the testing ofthese respirators demonstrates performance at a level ofprotection of!,000 or greater to receive an APF of!,OOO. This level of perfollllance can best be demonstrated by performing a Workplace Protection Factor (WPF) or Simulated Workplace Protection Factor (SWPF) study or equivalent testing. Without testing data that demonstrates a level ofprotection of 1,000 or greater, all PAPRs and SARs with helmets/hoods are to be treated as loose-fitting facepiece respirators, and receive an APF of25.- 29-

(3) Reductions in Respiratory Protection. After appropriate respiratoryprotection has been selected based 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 respiratoryprotection required bythe Protection in the Workplace section ofthis Order (unless it is the same as required bythis New Chemical Exposure Limit section). Before the Company maymake any reduction in anyrespiratory 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 newrespiratoryprotection.is appropriate in accordance with paragraph (e)(2). Where these PMN substances are manufactured, processed, orused in batches ofduration less than 7 days, the 2 consecutivemeasurements maybe taken at least 24 hours apart, provided that the measurements accuratelyreflect thehighest peak exposures and variability in exposure. (4) Special Situations. (i) Measurements Outside Ommtitation 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 estimatepotential exposure using generally established and accepted statistical methods. Ifthe Company obtains an exposure monitoring sample that is more than 10% above the actual upper quantitation limit ("UQL") ofthe analytical method, the Company must
ensure that its workers wear at least a NIOSH-certified supplied-air respirator operated in pressure demand or otherpositivepressure mode and equipped with a tight-fitting full facepiece. Any reductions in this respiratoryprotection must comply with paragraph (e)01)
.. The Company may- 30- submit an improved analytical method provided that it complies fully with subsection (c) ofthis New Chemical Exposure Limit section, including the velification required by subsection (c)(3). (ii) Cleanup and Remedial Actions. During any special cleanup or otherremedial
. actions that may occurbefore commencing additional exposure monitoring (as discussed in paragraph (d)(5)(ii)), the Company shall ensure that potentially exposedpersons use at least the respiratoryprotection specified above in this subsection (e) for the measured airborne concentration, or moreprotective respiratory equipment deemed appropriate bythe best professionaljudgment ofa qualified expert.
(f) NCELRecordkeeping. (I) Whenever the Company elects to comply with this New Chemical Exposure Limit section rather than 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 makethem 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 of their accuracy over time as required by section (c); (ii) Records documenting compliance with the analytical method verification requirements ofsubsection (c)(3), including copies ofthe signed celiification statement and the verification results obtained byboth laboratories; (iii) Records documenting either compliance with the Good Laboratory Practice Standards at 40 CPR Part 7Q2, oruse ofa laboratory accredited bythe AIHA or another- 31

- comparable program approved in advance in writing by EPA. Where the Company elects to not complywith TSCA GLPS, such records shall includethe wlitten accreditation from the AIHA or the written approval from EPA. (iv) Records documenting all exposure monitoring dates, duration, and results of each sample taken; (v) Records documenting the name, address, work shift,job classification, and work area ofthe person monitored and ofall otherpersons whose exposures the monitoring is intel),ded to represent; (vi) Any conditions that mighthave affected the monitoringresults; (vii) Notification ofexposuremonitoring results requiredbyparagraph (d)(6); (viii) Records documenting any changes in the production, process, control equipment, personnel or work practices that mayreasonably cause new or additional exposures to these PMN substances; (ix) Records documenting any spills, leaks, ruptures or otherbreakdowns that may
cause new or additional exposure;

substances; (x) The type ofrespiratoryprotective devices wornby the monitored person, ifany; (xi) Records documenting any actions taken to mitigate exposures to these PMN
(xii) Records documenting reliance on the objective data exemption in paragraph (d)(7), including: (A) the source ofthe data, (B) protocols and results ofany relevant testing or analysis, (C) a description ofthe operation exempted and how the data demonstrate that employee exposures will notexceed the action level, (D},other datarelevant to the operations, materials and- 32- employee exposures covered by the exemption.

HAZARD COMMUNICATION PROGRAM (a) Written Hazard Communication Program. The Company shall develop and implement a written hazard communication program for these PMN substances in each workplace. The written program will, at a minimum, describe how therequirements ofthis section for labels, MSDSs, and other forms ofwamingmaterial will be satisfied. The Companymustmake the written hazard communicationprogram available, upon request, to all employees, contractor employees, and their designated representatives. The Companymayrely on an existing hazard communication program, including an existing program established under the OSHA Hazard Communication Standard (29 CPR 1910.1200),to complywith this paragraph provided that the existing hazard communication program satisfies therequirements ofthis section. The written program shall include the following: (1) A list ofchemical substances known to bepresent in the work area which are subject to
a TSCA section 5(e) consent order signed bythe Company or to a TSCA section 5(a)(2) SNUR at 40 C.P.R. Part 721, subpart E. The list must bemaintained in each work area wherethese PMN substances are known to bepresent and must use the identityprovided on the MSDS for the substancerequired under paragraph (c) ofthis section. The list maybe compiled for the workplace·
or for individual work areas. Ifthe Company is required eitherby another Orderissued under section 5(e) ofTSCA, orby a TSCA section 5(a)(2) SNUR at 40 CPR Part 721, subpart E, to maintain a list ofsubstances, the lists shall be combined withthe list underthis subparagraph. (2) Themethods the Companywill use to inform employees onhe hazards ofnon-routine- 33

- tasks involving these PMN substances (e.g., cleaning ofreactor vessels), and the hazaxds associated with these PMN substances contained in unlabeled pipes in their work axea. (3) The methods the Companywill use to infom1 contractors ofthe presence ofthese PMN substances in the Company's workplace and oftheprovisions ofthis Order ifemployees ofthe contractor work in the Company's workplace and axe reasonablylikelyto be exposedto these PMN substances 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 subparagxaph (b)(1). (i) The label shall, at a minimum, contain the following information: (I) A statement ofthe health hazaxds(s) and precautionarymeasure(s), if any, identified in paxagxaph (1) ofthis section orbythe Company, for these PMN substances. (II) The identitybywhich each PMN substance maybe commonly

.recognized. (III) A statement ofthe environmental hazard(s) and precautionary

measure(s), ifany, identified in paxagraph (1) ofthis section, orbythe Company, for these PMN substances. (IV) A statement ofexposure and precautionarymeasure(s), ifany, identified in paragxaph (1) ofthis section, orby the Company, for these PMN substances. (ii) The Company mayuse signs, placaxds, process sheets, batch tickets, operating procedures, or**oth~r\such** written materials in lieu ofaffixing labels to individual stati?naxy process- 34

- containers, as long as the alternative method identifies the containers to which it is applicable and conveys information specified by subparagraph (b)(1lei) ofthis section. Anywritten materials must be readily accessible to the employees in their work areas throughout each work shift. (iii) The Companyneed not label portable containers into which these PMN substances are transferred from labeled containers, and which are intended only for the immediate
use ofthe employee who performs the transfer. (iv) The Company shall not remove or deface an existing label on containers of these PMN substances obtained from persons outside the Companyunless the container is immediatelyre-labeled with theinformation specified in subparagraph (b)(I)(i) ofthis section. (2) The Company shall ensurethat 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: (1) The information prescribed in subparagraph (b)(1lei) ofthis section. (II) Thename and address ofthe manufacturer or a responsible party who
can provide additional information on the substance for hazard evaluation and any appropriate emergencyprocedures. (ii) The label shall not conflict with therequirements ofthe Hazardous Materials Transportation Act (18 U.S.c. 1801 et. seq.) and regulations issued underthat Actbythe 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.- 35

- (5) Ifthe label or alternative form ofwamingis to be applied to a mixture containing these PMN substancse in combination with any other substance that is either subject to another TSCA section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 CPR Part 721, subpart E, ordefined as a "hazardous chemical"under the OSHA Hazard Communication Standard (29 CFR 1900.1200), the Companymayprescribe on the label, MSDS,
or alternative form ofwarning, the measures to cohtrol worker exposure or environmental release which the Company determines provide the greatest degree ofprotection. However, should these control measures differ fi·om the applicable nleasures required Ullder this Order, the Companymust seek a determination ofequivalency for such altemative control measures pursuant to 40 CPR 721.30 before prescribing them underthis subparagraph 

### (b)(5). (6) Ifthe Companybecomes aware ofany significant new information regarding the hazards ofthese PMN substances orways to protect against the hazards, this new infomlationmust be added to the label witllin 3 months from thetime the Companybecomes aware ofthenew information. Ifthese PMN substances are notbeingmanufactured, imported, processed, orused in the Company's workplace, the Companymust add the new infoTInation to the label before these PMN substances is reintroduced into the workplace.
(c) Material SafetyData Sheets. (1) The Companymust obtain or develop an MSDS for these PMN substances. (2) The MSDS shall contain, at a minimum, the following information: (i) The identity used on the container label ofthese PMN substances under this section, and, ifnot claimed confidential, the chemical and common name ofthese PMN

### - 36-
substances. lfthe chemical and common name is claimed confidential, a generic chemical name mustbe used. (ii) Physical and chemical characteristics ofthe substance known to the Company, (e.g., vaporpressure, flash point). (iii) The physical hazards ofthe substance known to the Company, including the potential for fire, explosion, and reactivity. (iv) The potential human and environmental hazards as specified in paragraph (f) ofthis section. (v) Signs and symptoms ofexposure, and any medical conditions which are expected to be aggravated by exposure to these PMN substances known to the Company. (vi) Theprimaryroutes ofexposure to these PMN substances. (vii) Precautionarymeasures to control worker exposure andlor environmental release required bythis Order, or alternative control measures which EPA has deternlined under40 CFR 721.30 provide substantially the same degree of protection as the identified control measures. TheMSDS must identify anyNew Chemical Exposure Limits specifiedin 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) oftheNew Chemical Exposme Limit section. (viii) Any generally applicable precautions for safehandling and use ofthese PMN substances which are known to the Company, including appropriate hygienicpractices, protective
measures during repair and maintenance ofcontaminated equipment, and procedmes for response to spills and leaks. (ix) Any generally applicable control measures which are \alown to the Company,- 37- such as appropriate engineering controls, work practices, orpersonal protective equipment. (x) Emergency first aid procedures known to the Company. (xi) The date ofpreparation ofthe MSDS or ofits last revision. (xii) The name, address, and telephone number ofthe Company or another responsiblepartywho 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 these PMN substances have similar compositions (i.e., the chemical ingredients are essentially the same, butthe specific composition varies from mixture to mixture) and similar hazards, the Companymayprepare one MSDS to apply to all of these multiple mixtures. (5) Ifthe Companybecomes aware ofany significant new information regarding the hazards ofthese PMN substances or ways to protect against the hazards, this new information must be added to the MSDS within 3 months from the time the Companybecomes aware ofthe new information. Ifthese PMN substances are not being manufactured, imported, processed, orused in the Company' Ii workplace, the Companymust add the new information to the MSDS before these PMN substances are reintroduced into the workplace. (6) The Companymust ensure that persons receiving these PMN substances from the Company are provided an appropliate MSDS with their initial shipment and with the first shipment after an MSDS is revised. The Company may either provide the MSDS with the shipped containers or send it to the personpriorto or at the time ofshipment.- 38

- (7) The Companymust maintain a copy ofthe MSDS in its workplace, and must ensure that it is readily accessible dming each work shift to employees when they are in their work areas. (8) The MSDS maybe kept in any form, including as operatingprocedures, and maybe designed to cover groups ofsubstances in a work area where it maybe more appropriate to address the potential hazards ofa process rather than individual substances. However, in all cases, the required information mustbe provided for these PMN substances and must be readily accessible during each work shiftto employees when they are in their work areas. (9) The MSDS must be printed in English; however, the information mayberepeated in otherlanguages.
(d) Employee Information and Training. The Companymust ensure that employees are provided with information and training on these PMN substances. This information and training mustbe provided at thetime ofeach employee's initial assignment to a work area containing these substances and whenever the PMN substances are introduced il1to the employee's work area for the first time. (1) The infOlmation provided to employees underthis paragraph shall include: (i) Therequirements ofthis section. (ii) Any operations in the work area where the PMN substances are present. (iii) The location and availability ofthe written hazard communicationprogram required underparagraph (a) ofthis section, including the list ofsubstances required by subparagraph (a)(1) ofthis section and MSDSs requiredbyparagraph (c) ofthis section. (2) The training provided to**employe~s.shall** include:- 39

- (i) Me.thods and observations that maybe used to detect the presence orrelease of these PMN substances in or from an employee's work area (such as exposure monitoring conducted bythe Company, continuous monitoring devices, visual appearance, or odor ofthe substance when beingreleased). (ii) Thepotential human health and environmental hazards ofthese PMN substances as specified in paragraph (f) ofthis section. (iii) The measures employees can taketo protect themselves and the enviromnent from these PMN substances, including specificprocedures the Companyhas implemented to protect employees and the enviromnent from exposure to these PMN substances, including appropriate work practices, emergencyprocedures, personal protective equipment, engineering controls, and other measures to control worker exposure and/or environmental releaserequired under this Order, or alternative cont·ol measures which EPA has determined under 40 CFR 721.30 providethe same degree ofprotection as the specified control measures. (iv) Therequirements ofthe hazard communicationprogram developed bythe Company under this section, including an explanation ofthe labeling system and the MSDS required bythis section and guidance on obtaining and using appropriate hazard information.
(e) De Minimis Concentrations. The requirements ofthis section do not applyto quantities of these PMN substances that are (1) present in the work area only as a mixture and (2) at a concentration not to exceed 1.0 percentbyweight or volume (0.1 percent by weight orvolume if the PMN substance(s) are identified as a potential carcinogen in paragraph (f) ofthe Hazard Communication Program section ofthis Order). This exemption.is not available ifthe Company

### - 40-
has reasonto believe that, during intended activities, these PMN substances in the mixture maybe reconcentrated above \he 1.0 or 0.1 percent level, whichever applies. Ifthis Order contains New Chemical Exposure Limits provisions or Release to Water provisions that, respectively, specify a NCEL concentration ("TWA") orin-stream concentration ("N") less \han the de minimis concentration specified here, \hen this de minimis exemption does not apply to \hose provisions.
(f) 

### Human Health, Exposure, and Precautionary Statements. The following human heal\h and environmental hazard and precautionary statements shall appear on each label as specified in paragraph (b) and the MSDS as specified in paragraph (c) of\his section: (1) Human health hazard statements. This substance may cause: (i) skin irritation. (ii) respiratory complications. (iii) central nervous system effects. (iv) internal organ effects. (v) birth defects
.

. (vi) reproductive effects.

(vii) cancer. (viii) immune system effects. (ix) developmental effects. (2) Human hazard precautionary statements. When using this substance: (i) avoid skin contact. (ii)'avoid breathing the substance.- 41

- (iii) avoid ingestion. (iv) use respiratory protection, or maintain workplace airborne concentrations at or below an 8-hourtime-weighted average of 0.32 mg/m3

. v) use skin protection.
(3) Environmental hazard statements. This substance maybe: (i) toxic to fish. (ii) toxicto aquatic organisms. (4) Environmental hazardprecautionary statements. Notice to users: (i) disposal restrictions apply. (ii) spill clean-up restrictions apply. (iii) do notrelease to water.
(5) Thehuman and environmental hazard andprecautionary statement on the label preparedpursuantto paragraph (b) ofthis sectionmustbe followed bythe statement: "See the MSDS for details."
(g) Existing Hazard Communication Program. The Companyneed nottake additional actions if existingprograms and procedures satisfytherequirements ofthis section.

### - 42- MANUFACTURING 

### (I) Prohibition. The Company shall not cause, encourage, or suggest the manufaGture or import ofthese PMN substances by any other person. (2) Sunset Following SNUR. Subparagraph (a)(I) shall expire 75 days afierpromulgation ofa final significant new use rule ("SNUR") governing these PMN substances under section 5(a)(2) ofTSCAunless the Companyis notified on orbeforethat day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, subparagraph (a)(1) shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have beenresolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. When EPA promulgates a final SNUR for these PMN substances and subparagraph (a)(I) expires in accordance with subparagraph (a)(2), the Company shall notify each person whom it causes, encourages or suggests to manufacture or import these PMN substances ofthe existence ofthe SNUR. DISTRIBUTION 

### (a) Export Notice Requirement. No later than the date ofdistribution, the Company shall notify in writing any person to whom it distributes these PMN substances that, due to the issuance ofthis Consent Order under. section 5(e) ofTSCA, these PMN substances are subject to the export notificationrequirements ofTSCA section 12(b) and 40 CFR Pmt 707 Subpart D. Such notice shall contain, in the fonn in which it appears in this Consent Order, the following information: (1) the PMN number(s), and (2) either (A) the specific chemical identity ofthe PMN substance(s), or (B) ifthe specific chemical identity is confidential, the generic chemical identity- 43

- (b) Distribution Reguirements. The Company shall distribute these PMN substances outside the Company, other than for disposal only to a person who has agreed in writing prior to the date of distribution to: (1) Notify in writing any person to whom it distributes these PMN substances that, due to the issuance ofthis Consent Order under section See) ofTSCA, these PMN substances are subject to the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 SubpaJ.i D. Such notice shall contain, in the form in which it appears in this Consent Order, the following information: (I) the PMN number(s), and (2) either (A) the specific chemical identity ofthe PMN substance(s), or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Comply with the same requirements and restrictions, ifany, required ofthe Company in the Protection in theWorkplace and the New Chemical Exposure Limit sections ofthis Order. (3) Comply with the same requirements and restrictions, ifany, required ofthe Company in the Hazard Communication Program section ofthis Order. (4) Comply with the same environmental release restriction, ifany, required ofthe Companyin the Release to Water section ofthis order.
(c) Temporary TranspOli and Storage. Notwithstanding paragraph (b), the Companymay distribute these PMN substances outside the Company for temporarytransport and storage in sealed containers (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 exempt temporary transport or storage ofsealed containers, these PMN substances maybe distributed only to the Company or a perso,n.,who has given the-44

- Companythe written agreement required byparagraph (b). (2) Anyhuman exposure resulting from opening the sealed containers and removing or washing out these PMN substances mayoccur only while these PMNsubstances are in the possession and control ofthe Company or a person who has given the Companythe written agreement required byparagraph (b).
(d) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of these PMN substances, the Company obtains knowledge that a recipient ofthe substancehas failed to coinplywith any ofthe conditions specified in paragraph (b) ofthis Distribution section or has eengaged in a significant new use ofthese PMN substances (as defined in 40 CFRPart 721, Subpart E) without submitting a significant newusenotice to EPA, the Company shall cease supplying the substanceto that recipient, unless the Company is able to document each ofthe following: (1) Thatthe Companyhas, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section, orhas engaged in a significant new use ofthese PMN substances without submitting a significant new use notice to EPA. (2) That, within 15 working days ofnotifying the recipient ofthe noncompliance, the Company received from the recipient, in writing, a statement ofassurance that the recipient is
aware ofthe terms ofparagraph (b) ofthis Distribution section and will comply with tllose terms,
or is aware ofthe terms ofthe significant new use rule for these PMN substances and will not engage in a significant newuse without submitting a significant new use notice to EPA.

### - 45

- (3) If, after receiving a statement ofassurance from a recipient under subparagraph (d)(2) ofthis Distribution section, the Company obtains knowledge that the recipient has failed to comply with any ofthe conditions specified in paragraph (b) ofthis Distribution section, or has engaged in
a significant new use ofthese PMN substances without submitting a significant new use notice to EPA, the Company shall cease supplying these PMN substances to thatrecipient, shall notify EPA ofthe failure to comply, and shall resume supplying these PMN substances to that recipient only upon written notification from the Agency.
(e) SunsetFollowing SNUR. (1) Paragraph (b)(2) ofthis Distribution section shall expire 75 days after promulgation ofa final SNUR for these PMN substances under section 5(a)(2) of TSCA, unless the Companyis notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Companyis so notified, paragraph (b)(2) ofthis Distribution section shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have beenresolved and the validity ofthe SNUR affirrned. (2) When EPA promulgates a final SNUR for thesePMN substances and paragraph (b)(2) ofthis Distribution section expires in accordance with subparagraph (e)(1), the Company shall notify each person to whom it distributes these PMN substances ofthe existence ofthe SNUR. Such' notification must be in writing and must specifically include all limitations contained in the SNUR which are defined as significant newuses, and which would invoke significant new use notification to EPA for these PMN substances. Such notice must also reference the publication of the SNUR for these PMN substances in either the Federal Register or the Code ofFederal Regulations. After promulgation ofa SNUR:and expiration ofsubparagraph (b)(2), such notice

### - 46-
may substitute for the written agreementrequired in the introductory clause ofparagraph (b); so that, ifthe Companyprovides such notice to the persons to whom it distributes these PMN substances, then the Companyis not required to obtain from such persons the written agreement specified in paragraph (b).

RELEASE TO WATER This provision does not supersede orpreempt any applicable federal, state, and local laws and regulations. (Those other laws maybemore stringentthan therequirements below.) The Company is prohibited from any predictable orpurposeful release ofthese PMN substances, or any waste stream from manufacturing, processing oruse containingthe PMN substance: (I)(a) Into the waters ofthe United States ifthe quotient from the formula: number ofkilograms/day/site released

-------------.----------------------------------- x 1000 = N parts perbillion receiving**~;tream** flow (million liters/day)
exceeds 5 ppb for PIl-327, Pll-328, Pll-329, Pll-330, Pll-331, and PIl-332 when calculated using the methods described in 40 CFR 721.91.
(b) In lieu ofcalculating the quotient in subparagraph (4)(a), monitoring or alternative calculations maybeusedto predict the surface water concentration expected to result from the intendedrelease ofthe substance, ifthe monitoring procedures or calculations havebeen approved for suchpurposeby EPA. EPA will review and act on a written request to approve monitoring procedures or alternative calculations within 90 days after such a request is received. TheAgency- 47

- will inform the Company ofthe disposition ofsuch requests in writing and, where a request is denied, will explain the reasons therefore.

III. 

### RECORDKEEPING (a) Records. The Company shall maintain the following records until 5 years afterthe date they
are created and shall make them available for inspection and copyingbyEPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that any ofthese PMN substances did in fact qualify for anyone ormore ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Suchrecords must satisfy all the statutory and regulatoryrecordkeeping requirements applicable to the exemptionbeing claimedby the Company. Any amounts orbatches ofthese PMN substances eligible for the Export exemption in Section I, Paragraph (b)(1) ofthis Order are exempt from all the requirements inthis Recordkeeping section, ifthe Companymaintains, for 5 years from the date oftheir creation, copies ofthe export label and export notice to EPA, required by TSCA sections 12(a)(I)(B) and 12(b), respectively. Any amounts orbatches ofthese PMN substances eligible for the Research and Development exemption in Section I, Paragraph (b)(2) ofthis Order,
are exempt from all the requirements in this Recordkeeping section, ifthe Companymaintains, for 5 years from the date oftheir creation, the records requiredby40 CFR 720.78(b). For any amounts or batches ofthese PMN substances claimed to be eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the Company shall keep records demonstrating qualification for that exemption as well as the records specified inparagraphs (2) and (3) below, but is exempt fi'omthe other recordkeepingrequirements in this Recordkeepingsection;- 48

- (2) Records documenting the manufacture and impOliation volume ofeach PMN substance and the corresponding dates ofmannfacture and import; (3) Records documentingthe names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Company directly sells ortransfers these PMN substances, the date ofeach sale ortransfer, and the quantity ofthe substance sold ortransferred on such date; (4) Records documenting the address ofall sites ofmanufacture, import, processing, and 

### use; (5) Records documenting establishment and implementation ofa program for the use of any applicable personal protective equipment required pursuant to the ProtectionintheWorkplace section ofthis Order; (6) Records documenting the detenninations required bythe Protection in the Workplace section ofthis Order that chemical protective clothing is impervious to these PMN substances; (7) Records required by paragraph (f). ofthe New Chemical Exposure Limits section of this Order, ifapplicable; (8) Records required by the release to water section ofthis Order. (9) Records documenting establishment and implementation ofthe hazard communication program required bythe Hazard Communication Program section ofthis Order; (10) Copies oflabe1s required under the Hazard Communication Program section ofthis Order; (11) Copies ofMaterial SafetyData Sheets required bythe Hazard Communication Program section ofthis Order;- 49- 

### (12) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing and Distribution sections ofthis Order, including distributees' written agreement to comply with the Distribution section ofthis Order; (13) Copies ofany Transfer Documents and notices required bythe Successor Liability section ofthis Order, ifapplicable; and (14) The Company shall keep a copy ofthis Order at each ofits sites where these PMN substances are manufactured or imported.
(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 Company is not required to respond to this "collection of information" unless this Order displays a cUlTently valid control number from the Office of Management and Budget ("OMB"), and EPA so informs the Company. The "collection of information" required in this TSCA §5(e) Consent Order has been approved under cUlTently valid OMB Control Number 2070-0012.- 50-
IV. REQUESTS FQRPRE-INSPECTION INFORMATION (a) EPA's Request for Infomlation. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyances associated with these PMN substances. To facilitate such inspections, EPApersoffi1el 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 include, but are not limited to, the following:
(I) Expected dates and times when these PMN substances will be in production within the subsequent 12 months; (2) Current workshift schedules for workers who are involved in activities associated with these PMN substances and may reasonablybe exposed to these PMN substances; (3) Currentjob titles or categories for workers who are involved in activities associated with these PMN substances and mayreasonablybe exposed to these PMN substances; (4) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance(s) and mayreasonably be exposed to these PMN substances; (5) Records required by the Recordkeeping section ofthisOrder; and!or (6) Any other infonnation reasonably related to determining compliance with this Order or conducting an inspection for thatpurpose.
(b) Company's Response. The Company shall respond to such requests within a reasonable period oftime, but in no event later than 30 days after receiving EPA's reqllest. Whenreqllested

# • - 51

- 

### in writing byEPA, the Company's response shall bein writing. To the extent the information is known to or reasonably ascertainable to 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 Infonnation ("CBI") that the Company submits to EPA pursuant to paragraph (b) 

### shall be protected in accordance with §

### 14 of TSCA and 40 CPR Part 2.

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Company's rights and obligations under this Order maybe transferred when the Company transfers its interests in these PMN substances, including the right to manufacture these PMN substances, to anotherperson outside the Company (the "SuccessorinInterest")
.
(b) 

### Relation ofTransfer Date to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Companyto the Successorin Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for these PMN substances from the Companypursuant to 40 CFR 720.102, the Successorin Interest must submit
a new PMN for each substance to EPA and comply fully with Section 5(a)(1) ofTSCA and 40 CPR part 720 before commencing manufacture or import ofthese PMN substances. (2) After NOC
..Ifthe transfer from the Company to the Successorin Interest.is.effeRtivl;)- 52 _. 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 Successor Liability section ofthe Order: (1) "Successor in Interest" means a person outside the Company who has acquired the Company's full interest inthe rights to manufacture any ofthese PMN substances, including all ownership rights and legal liabilities, through a transfer document signed bythe Company, as transferor, andthe Successor in Interest,as transferee. Theterm excludes persons who acquire less than the full interest ofthe Company in these PMN substances, such as a licensee who has acquired a limited licenseto the patent ormanufactUllng rights associated withthese PMN substances. A Successor in Interest mustbe incorporated, licensed, or doingbusiness in the United States in .accordance with 40 CFR n0.22(a)(3). (2) "Transfer Document" means the legal instrUlnent(s) usedto conveythe interests in these PMN substances, including the right to manufacturethese PMN substances, from the Companyto the Successor in Interest.
(d) Notices. (1) Notice to Successor in Interest. On or before the effective date ofthe transfer, the Company shall provide to the Successorin Interest, byregistered mail, a copy ofthe Consent Orderand the "Notice of Transfer" document which is incorporated by reference as Attachment C to this Order. (2) Notice to EPA. Within. 10 business daysoftheeffective date ofthe transfer, the- 53

- Company shall, byregistered mail, submit the fully executed Notice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pellrlsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe Transfer Document mustbemaintainedby the Successor in Interestat its principal place ofbusiness, and at all sites where these PMN substances
are manufactured orimported. Copies ofthe Transfer Document must also bemade available for inspection pursuant to Section 11 ofTSCA, must state the effective date oftransfer, and must containprovisions which expressly transfer liability for these PMN substances under the terms of this Order from the Companyto the SuccessorinInterest.
(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 withthe 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, or omissions made; during the time in which the Companymanufactured, processed, used, or distributed in commerce ofthese PMN substances pursuantto the terms ofthis Consent Order.- 54-
VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company maypetition EPA at any time, based upon new information on the health effects of, or human exposure to, these PMN substances, to modify or revoke substantive provisions ofthis Order. The exposures and risks identifiedby EPA during its review ofthese PMN substances and the information EPA determined to benecessary to evaluate those exposures andrisks are described in thepreambleto this Order. However, in determining whether to amend
or revoke this Order, EPA will consider all relevant infonnation available at the time the Agency makes that determination, including, where appropriate, anyreassessment ofthe test data or other information that supports the findings inthis Order, an examination ofnew test data or other information or analysis, and any otherrelevant information. EPA will issue a modification orrevocation ifEPA determines that the activities proposed therein will notpresent an unreasonable risk ofinjury to health orthe environment and will not result in significant or substantial hmnan exposure or substantial enviromnentalrelease in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects of these PMN substances. In addition, the Company maypetition EPA at anytimeto makeother modifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure andintent ofthis Order as issued.- 55

- 

### VII. EFFECT OF CONSENT ORDER (a) Waiver. By consenting to the entry ofthis Order, the Company waives its rights to file objections to this Orderpursuant to section 5(e)(1)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the end ofthe review periodpursuant to section 5(e)(1)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to beboundbyits terms, do not constitute an admission bythe Company as to the facts or conclusions underlying the Agency's detem1inations in this proceeding. This waiver does not affect any otherrights that the Company mayhave under TSCA.
(b) CBI Brackets. By signing this Order, the Companyrepresents that it has carefullyreviewed this document and hereby agrees that all information herein that is claimed as confidential bythe Company (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFRPart 2) is correctly identified within brackets and that any infonnation that is not bracketedis not claimed as confidential. To make this document available for public viewing, EPAwill remove onlythe infonnation contained within the brackets.

Director Chemical Control Division Office ofPollution Prevention and ToxicsATTACHMENT A DEFINITIONS
Note: The attached Order may not contain some of the terms defined below. "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed by the Chemical Abstracts Service's rules of nomenclature, or a name which

### will clearlyidentify a chemical substance for the purpose of conducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protectivebarrier to prevent dermal contact with chemical substances ofconcern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves,jackets, and pants. "Company"means the person orpersons subject to this Order. "Commercial use" meansthe use ofa chemical substance or anymixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establislnnent orpainting contractor). "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical nameused to identify a chemical substance other than byits chemical name. "Consumer"means a private individual who uses a chemical substance or any product containing the chemical substance in or around a pennanent or temporaryhousehold orresidence, during recreation, or for anypersonal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold ormade available to consumers for their use in or around a pennanent ortemporary household orresidence, in or around a school, or inrecreation. "Container" means anybag, 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. "ContractManufacturer" means a person, outside the Company, who is authorized to manufactnre and impOli these PMN substances under the conditions specified in Part II. ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance."Immediateuse." A chemical substance is for the "immediateuse" ofa person ifit is under the control of, and used onlyby, the person who transferred it from a labeled container and will only beused bythat person within the work shift in which it is transferred from the labeled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical or mechanical degradation, penneation, orpenetration ofthe chemical protective clothingunder the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance. "NIOSH"means the National Institute for Occupational Safety and Health ofthe U.S. Department ofHealth and Hwnan Services. "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemical substance and the workplace air may occur. "Non-industrial use" means use other than at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacture notice submittedby the Companyrelevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the bodyto prevent contact with, and exposure to, an identified chemical substance or substances in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types ofrespirators. Barrier creams are not included in this definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa (,hemical substance, regardless ofphysical state or concentration, through all intended operations of processing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA reviewed protocol or the Good Laboratory Practice Standards at 40 CFRPart 792 without prior or subsequent Agency review that prevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. "Scientifically equivocal data" means data which, although developed in apparentconfonnity with the Good Laboratory Practice Standards and EPA reviewedprotocols, are inconclusive, internally inconsistent, or otherwise insufficient to pennit a reasoned evaluation of the potential risk ofinjury to human health orthe environment ofthe PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-tenn containment ofthe PMN substance, and from which there will be no human exposure to, or environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumeruse.. "Waters oftheUnited States" has the meaning set forth in 40 CFR 122.2. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishmentat one geographic location containing one ormore work areas.ATTACHMENT B STATISTICAL ANALYSIS OF NCELsANALYTICAL METHOD VERIFICATION RESULTS This Attachment describes the statistical teclmique (with examples) for comparing the analytical results obtainedby two laboratories pursuant to paragraph (c)(3)(vii) ofthe New Chemical Exposure Limit section,ofthis Order. STATISTICAL TECHNIQUE To obtain two-sample t test with unequal variances, perform the following operations:
10 Compute means ofthe datameasuredbytwo laboratOlies.
10 Compute mean squares

10 Form the ratio

10 Compute degrees offreedom

where,

- Xl = Average ofthe results from the company laboratory X2 = Average ofthe results fi-om the independent laboratory nl = Number ofsamples analyzed bythe company laboratory n2 = Number ofsamples analyzed bythe independent laboratory.2 Then compare the absolute value ofTto the 97.5 percentile pointofat distribution with f degrees offi:eedom. Ifthe absolute value exceeds the 97.5 percentile point, the results measured bytwo laboratories are significantly different at 95% level. Otherwise, they are not significantly different. In general, fmay not be an integer. Use interpolation to obtain the 97.5 percentilepoint ofa t distribution with f degrees offreedom.

EXAMPLES

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

XI 

### = 83.30 Data Set 1 80.56 100,01

86;04 52.61 84.85 95.75

Absolute value ofT = 2.467 

# sl= 9.26 f= 5.33 Data Set2 97.11 1'02.13

99.83 97.83 105.44 100.04 n2 = 

### 6

The t table shows that the 97.5 percentile point is 2.571 and 2.447 for 5 and 6 degrees of freedom, respectively. For 5.33 degrees offreedom, the 97.5 percentilepoint will be approxirnately 2.530 which is greater than the absolute value ofT, 2.467. Hence, the means of two data sets are not significantly different at the 5% level. However, ifthis problem hadbeen treated as an ordinary two-sample t test, the means would be significantly different at the 5% level because the absolute ofT is greater than 2.228, the 97.5 percentile point for the t distribntion with 10 degrees offreedom. Example 2 Data Set 1 Data Set 2 82.87 108.05 101.85 96.51

87.44 100.04 99.68 104.33 101.15 110.32

99.21 107.003

- - Xl 

### = 95.37 nI = 6 

### X2 = 104.37 SII = 65.59 WI = 10.93 

# sl =27.25 W2 

### =4.54 Absolute value ofT = 2.290 f= 8.54 The t table shows that for 8.and 9 degrees offreedom the 97.5 percentilepoint is 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 absolutevalue ofT, 2.290. Hence, the means oftwo data sets are significantly different atthe 5% level.Company (Transferor) ATTACHMENT C NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER

PMNNumber
I. Transfer ofManufacture Rights. Effective on , the Company did sell or otherwise transfer to , ("Successor 

### inInterest") 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 Orderissued bythe U.S. Environmental Protection Agency ("EPA") under the authority of§5(e) ofthe Toxic Substances Control Act ("TSCA," IS U.S.C. §2604(e».
2. Assumption ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed bythe applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall bethe responsibility ofthe Successorin Interest. Successorin Interest also certifies that it is incorporated, licensed, or doing business iI1 the United States 

### in accordance with 40 CFR nO.22(a)(3)
.. 3. Confidential Business Information. The Successor in Interest hereby:

_ reasserts,

_ relinquishes, or modifies all Confidential Business Infonnation ("CBI") claims madebythe Company,.pursuant to Section 14 ofTSCA and 40 CFRpart 2, for the PMN sUbstance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer. Infonnation which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBI by the original submitter) would not subsequentlybe eligible for confidential treatment under this Notice ofTransfer.1

TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER

Company (Transferor)
Signature ofAuthorized Official NOTICE OF TRANSFER (continued)
PMNNumber

Date
Printed Name ofAuthorized Official
Title ofAuthorized Official

Succ.essor in Interest
Signature ofAuthorized Official Date
PrintedName ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code2

TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER NOTICE OF TRANSFER (continued)

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