UNITED STATES.ENVIRONMENTAL PROTECTIONAGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF NEW CHEMICAL SUBSTANCES

PENDINGDEVELOPMENT OF INFORMATION 

### Inthe matter of: ) ) )- ) ) 

### ) ) ) ) ) ) 

### ) ) ) ) ) ) ) ) ) ) ) 

### ) 

### ) ) ) PremanufactureNoticeNumbers:

Nano-C, Inc. 

# EPA SANITIZED

P-09-54-57

Consent Order, Consent Orderfor Processor, and Determinations Supporting Consent OrdersII 

### TABLE OF CONTENTS

Preamble I. 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 Effects

Consent Order I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Recordkeeping IV. Requests for Pre-Inspection Information V. Successor Liability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order Attachment A - Definitions Attachment B - Notice ofTransfer ofConsent Order Attachment C - Consent Order for Processoriii 

## PREAMBLE I INTRODUCTION Underthe authority of

### § 5( e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 2604(e», the Environmental Protection Agency ("EPA" or "the Agency") issues the attached Order, regarding premanufacture notices ("PMN") P-09-54-57 for the following chemical substances, P-09-54

- [5,6]Fullerene-C60-Ih, P-09-55

-**[5,6]Fullerene-C70~D5h(6),** P-09-56

- [5,6]Fullerene-C84-D2, P-09-57

- [5,6]Fullerene-C84-D2d, (the "PMN substances"), submitted by Nano-C, Inc. ("the Company"), to take effect upon expiration ofthe PMN reviewperiod. The Companysubmitted the PMNs to EPA pursuantto section 5(a)(1) of TSCA and 40 CFRPart 720.
Under 

### § 15 ofTSCA, it is unlawful for any person to fail orrefuse to comply with any provision of

### § 5 or any order issuedunder

### § 5. Violators may be subjectto various penalties and to both criminal and civil liabilitypursuantto 

### § 16, and to specific enforcement and seizure pursuant to 

### § 17. In addition, chemical substances subject to an Order issued under § 5 of TSCA, such as this one, are subjectto the 

### § 12(b) export notice requirement.



### II. SUMMARY OFTERMS OF THE ORDER The Consent Order for these PMN substances requires the Company to: (1) Submit certain physical/chemical properties data before exceeding a specified time period; (2)
. Provide workers with impervious gloves and clothing that covers any other exposed areas of the arms, legs, and torso;iv (3) Provide workers with a NIOSH-approved full-face respirator with an N -100 cartridge while exposedby inhalation in the work area; (4) Manufacture, process and use the PMN substances only as: (I) an intermediate compound for use in producing downstream products that will intum be used in organic electronic devices and an additive to improve mechanical properties or conductivity; (2) a compoundused to improve the mechanical properties ofrubbers, plastics, and lubricants; and (3) a compound for
use as an additive to increase the conductivity ofmaterials; (5) Distribute the PMN substances only to a person who agrees to follow the same restrictions (exceptthe testing requirements); (6) Comply withthe Release to Waterprovisions; and (7) Maintain certain records. A Consent Order for Processor is attached to extend these requirements to any Processor.


### III. CONTENTS OF PMN By signing this Order, the Company represents that it has carefully reviewed this
. document and hereby agrees that: all information herein that is claimed as confidentialbythe Company (per section 14 ofTSCA, 40 CFRPart 720 Subpart E, and 40 CFRPart 2) is correctly identified within brackets and that anyinformation that is not bracketed is not claimed as confidential. To makethis document available for public viewing, EPA will remove only the information contained within the brackets. Confidential Business Information Claims (Bracketed in the Preamble and Order): Production volume, impurities, byproducts, process information, environmental release and disposal information, and worker/occupational exposure.

### v Chemical Identity: P-09-54

- [5,6]Fullerene-C60-Ih, P-09-55

- [5,6]FuIlerene-C70-D5h(6), P-09-56

- [5,6]FuIlerene-C84-D2, and P-09-57

- [5,6]Fullerene-C84-D2d. Use: (1) an intermediate compound for use in producing downstream products that will in 

### turn be used in organic electronic devices and an additive to improve mechanical properties or conductivity; (2) compound used to improve the mechanical properties ofrubbers, plastics, and lubricants; and (3) compound for use as an additive to increase the conductivity ofmaterials.
Maximum 12-MonthProduction Volume: P-09-54 - [ ] kg/yr, P-09-55 - [ ] kg/yr, P-09-56 

### & 57 combined - [ ] kg/yr. TestData Submittedwith PMN: Particle size distribution and some otherphysical-chemical data.


### IV. EPA'S ASSESSMENT OF RISK The following are EPA's predictionsregarding the probable toxicity, human exposure and environmental release ofthePMN substances, based on the information currently available to the Agency. Human Health'Effects Summary: Absorption: absorption is expected to be poorvia all routes based ontest datafor chemicals with similarmolecular structures and chemicals with similarphysical/chemical properties described in the EPARespirable, Poorly Soluble Particulates chemical category. See www.epagov/opptlnewchems/pubs/cat02.htrn#RespirableVI Toxicological Endpoints ofConcern: 1) Immunotoxicityhazard

- pulmonary exposure to these PMN substances may lead to reduced alveolar macrophage phagocytosis, impaired clearance ofinhaledbacteria, inflammation, and possible systemic immunosuppression. (2) Oncogenicityhazard -longterm exposure may lead to carcinogenesis, induce oxidative stress, cause DNA effects, and result inphoto toxicity. (3) Mutagenicity hazards

- the PMN substances may be weak inducers ofaneuploidy, may induce DNA effects in mammalian cells in culture, may induce gene mutations in mammalian cells in culture. Occupational Exposure
Table 1 PMN# No. ofSites Total No. Inhalation Dermal ofWorkers (mg/day) (mg/day)
. Manufacturing P09-54 

### [ ] [ ] 1.3 12-90 P09-55 

## [] [ ] 0.64 12-90 P09-5617 

### [ ] [ ] 0.19 12-90
ProcessinglUse 1 P09-54 [ 

### ] 

### [ ] 1.0 12-90 P09-55 

### [ ] 

### [ ] 0.52 12-90 P09-56/7 

### [ ] 

### [ ] 0.19 12-90
Use 2 and 3

- [] P09-54 

### [ ] 

### [ ] 0.026 12-90 P09-55 

### [ ] 

## [1 0.013 12-90 P09-56/7 

### [ ] 

## [1 0.19 12-90Vll



### Environmental releases: From manufacturing: incineration or landfill, total- [ 

## 1 kg/y From ProcessinglUse I: incineration or landfill, total- [ 

## 1 kg/y From Use 2/3: incineration or landfill, total- [ 

## 1 kg/y
Risk to Workers: The PMN substances maypresent a risk to workers exposed to the PMN substances via inhalation. Risk to General Population: There is potential for exposure to the general population and the environment from landfill andlor incineration releases as well as fugitive air releases. Hnman inhalation, ingestion and dermal exposure mayresult from the landfill, incineration and fugitive releases.



### V. EPA'S CONCLUSIONS OF LAW The following findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine the potential for human health effects from exposure to the PMN substances. EPA therefore concludes, pursuant to 

### § 5(e)(I)(A)(i) ofTSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation ofthe hnmanhealth effects ofthe PMN substances.

(b) In light ofthe potential risk to human healthposedby the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances, EPA hasVlll concluded, pursuant to 

### § 5(e)(1)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances may present an unreasonable risk ofinjury to human health.



### VI. INFORMATION REOUIRED TO EVALUATE HEALTH EFFECTS Triggered Testing. The Order prohibits the Company from exceeding a specified production limit unless the Company submits the information described in the Testing section ofthis Order in accordance with the conditions specified in the Testing section.
Pended Testing. The following additional information wouldbe required to evaluate human health effects which may be causedbythe PMN substance: Information 90-day inhalation toxicity study for the substances in P-09-55, P-09-56, and P-09-57 Dispersion and solubility infresh water, without the use ofdispersants/solvents

Comparison ofElectrokinetic Properties ofColloidal Fullerenes (n-C60) Formed Using Two Procedures Guidelines OCSPP 870.3465

Naphthalene AdsQrption 

### and desorption from aqueous C60 fullerene, J. Chern. Eng. Data 2004, 49, 675-683
Jonathan Brant,HeaLeo Nelecoanet, Matt Hotze and Mark Wiesner, Environ. Sci. Techno!. 2005, 39, 6243- 6351IX
The Order does not require submission ofthe above pendedtesting at any specified time or production volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances will remain in effect until the Order is modified orrevoked by EPA based on submission ofthat or otherrelevant information.

## CONSENT ORDER I. SCOPE OF APPLICABILITYAND EXEMPTIONS (a) Scope. The requirements ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal, in the United States, ofthe following chemical substances, [S,6]Fullerene-C60-Ih (P09-S4), [5,6]Fullerene -C70-DSh(6) (P-09-SS), [S,6]Fullerene-C84-D2 (P-09-S6), [S,6]Fullerene-C84-D2d (p-09-S7), (the "PMN substances"), submittedbyNano-C, Inc. ("the Company"), except to the extentthat those activities are exempted by paragraph (b). (b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe 

### PMN substances are exempt from the requirements ofthis Order (except the requirements 

### in the Recordkeepingand SUQcessQr LiabilityUpon Transfer OfConsent Order sections) only to the extent that (1) these activities are conducted in full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section ofthis Order. (1) Mitigated States ofthe 

### PMN Substances The requirements ofthis Order 

### do not apply to quantities ofthe PMN substances that have been (i) completely reacted (cured); (ii) 

### incorporated or embedded into a polymer rnatrix that itselfhas 

### been reacted (cured); (iii) embedded in a permanent solid polymerform that is not intended to undergo further processing2 except for mechanical processing; or (iv) incorporated into an article as defined at 40 CFR 720.3(c). (2) Export. Until the Company begins commercial manufacture ofthe PMN substances for use in the United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe PMN substances solely for export in accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFRPart 707. However, once the Company begins to manufacture the PMN substances for use in the United States, no further activities by the Company involving the PMN substances are exempt as "solely for export" evenifsome amounts ofthe PMN substances are later exported. Atthatpoint, the requirements ofthis Order applyto aU activities associated withthe PMN substances while in the territory oftheUnited States. Prior to leaving U.S. territory, eventhose quantities orbatches ofthe PMN substances that are destined for export are subject to terms ofthe Order, and count towards any production volume testtriggers in the Testing section ofthis Order. (3) Research & Development ("R&D"). Therequirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances in small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR nO.3(cc), and 40 CFR720.36. (4) Byproducts. The requirements ofthis Order do not apply to the PMN substances when they areproduced, without separate commercial intent, only as "byproducts" as defined at 40 CFR 720.3(d) and in compliance with 40 CFR nO.30(g). (5) No Separate Commercial Purpose. The requirements ofthis Order do not apply to the PMN substances when they are manufactured, processed, distributed in commerce, used and/or disposed ofpursuant to any ofthe exemptions in 40 CFR nOJO(h), with no commercial3 purpose separate from the substances, mixture, or article ofwhich they are a part.
(c) Automatic Sunset. lfthe Company has obtainedfor the PMN substances a Test Market Exemption ("TME") under TSCA §5(h)(1) and 40 CFR 720.38 or a LowVolume Exemption ("L VE") or LowRelease and Exposure Exemption ("LoREx") under TSCA §5(h)(4) and 40 CFR 723.50(c)(1) and (2) respectively, any such exemptionisautomatically rendered null and void as ofthe effective date ofthis Consent Order.



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

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION
PROHIBITION The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, ordisposing ofthe PMN substances in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe humanhealth effects ofthe substanees, and the completion ofEPA'sreview of, and regulatory action based on, that information, except in accordance with the conditions described 

### inthis Order.



### TESTING (a) Section 8ee) Reporting. Any information on the PMN substances which reasonably supports the conclusion that the PMN substances present a substantial risk ofinjury to health or the

### 4 environmentrequired to be reported under EPA's section 8(e) policy statementat 43 Federal Register 11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70 Federal Register 2162 (January 12,2005), shall reference the appropriate PMN identification numbers for these substances and shall contain a statement that the substances are subject to this Consent Order. Additional information regarding section 8(e) reporting requirements can be found in the reporting guide referenced at 56 Federal Register 28458 (June 20,1991).
(b) Notice ofStudy Scheduling. The Company shall notify, inwriting, the EPALaboratory DataIntegrity Branch (2225A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study required to beperformed pursuantto this Order, orwithin IS days after the effective date ofthis Order, whichever is**later~** (1) The 

### date when the study is scheduled to commence; (2) The name and address ofthe laboratory which will conduct the study; (3) The name andtelephone number ofa person atthe Company orthe laboratory whom EPA may contactregarding the study; and (4) The appropriate PMN identification numbers for the substances and a statementthat the substances are subject to this Consent Order.

(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be performed pursuant to this Order must be conducted according to TSCA Good Laboratory Practice Standards at 40 CFRPart 792 and using methodologies generally accepted in the

### 5 relevant scientific community at the time the study is initiated. Before startingto conduct any such study, the Company must obtain approval oftest protocols from EPAby submitting written protocols. EPA will respond to theCompany within 4 weeks ofreceiving the written protocols. Published test guidelines specified in paragraph (d) provide general guidance for development of test protocols, but are not themselves acceptable protocols. Approval ofthe testprotocol does not meanpre-acceptance oftest results.
(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or importing, or causing another personto manufacture or import, any ofthe PMN substances beyond 9 months after the first date ofcommencement ofnonexempt commercial manufacture or import ofanyone ofthePMN substances ("the productionlimit"), unless the Companyprovides the following data for each ofthe PMN substances (except that only one set ofdata is required for the P09-56 and P09-57 substances combined) and submits all final reports and underlying datain accordance with the conditions specified in this Testing section:

- Dry particle size distribution by count for each PMN substancein a form which has the highest content ofparticles smallerthan 10 microns as manuf{lctUfed, processed-orused in the workplace at sites controlledby the Company. The method shall be STEM (scanning transmission electron microscopy), using a dry particle counting method, with a resolution of 

### < 1 nanometer and with no counting after dispersionin a solution and evaporating solvent.

- Dustiness (EN 15051 method). Description ofthe physical-chemical properties ofthe material tested should take into consideration the characterizations identified in the most recent version ofthe Guidance Manual for the Testing ofManufactured Nanomaterials: OECD's Sponsorship Progranune.6 (e) TestReports. The Company shall: (1) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPAthe results ofany interim phase of each study; and (3) submit, intriplicate (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA no later than 14 weeks prior to exceeding the applicable production limit. The final report shall containthe contents specified in 40 CFR 792.185. Underlying data shall be submitted to EPA in accordance with the applicable "Reporting", "Dataand Reporting", and "TestReport" subparagraph.s inthe applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clearthat the submission ofsuch information is mandatory. EPA will notrequire the submission ofraw data such as slides and laboratory notebooks unless ifEPA finds, onthe basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannottake place in the absence ofthese items.


### (f) Testing Waivers. The Company is notrequired to conduct a study specified inparagraph (d) ofthis Testing section ifnotified inwriting by EPAthat it is unnecessary to conduct that study.
(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Company may continue to manufacture and import the PMN substances beyond the applicable production limit. To seek relieffrom any otherrestrictions ofthis Order, the Company may make a second attempt to obtain unequivocal data by reconducting the study under the conditions specified inparagraphs (b), (c), and (e)(1) and (2). The testing requirements maybe modified, as necessary to permit a reasoned evaluation ofthe risks presentedbythe PMN7 substances, only by mutual consentofEPA and the Company.
(h) EPA Detennination ofInvalid Data. (1) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa test report and data, the Company receives written notice thatEPA finds that the data generated by
a study are scientifically invalid, the Company is prohibited from further manufacture and import ofthe PMN substances beyond the applicable production limit. (2) The Company may continue to manufacture and import the PMN substances beyond the applicable production limit only ifso notified, in writing, by EPA in response to the Company's compliance with eitherofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Company may reconduct the study in compliance withparagraphs(b), (c), and (e)(l) and (2). Ifthere is sufficienttime to reconduct the study and submitthe report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Company to comply with subparagraph (f)(3), the Company may exceed the production limit and shall submitthe report and data intriplicate to EPA within a reasonable period oftime, all as specified by EPA in the notice describedin subparagraph (h)(l). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data.
(ii) The Companymay, within 4 weeks ofreceiving from EPAthe notice described in subparagraph (h)(!), submit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.8 (i) Company Determination ofInvalid Data (1)Exceptas described in subparagraph (i)(2), ifthe Company becomes aware that circumstances clearly beyond the control ofthe Company or laboratory will prevent, or have prevented, development ofscientifically valid data under the conditions specified inparagraphs (c) and (e), the Company remains prohibited from further manufacture and import ofthe PMN substances beyond the applicable production limit. (2) The Companymay submitto EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearlybeyond the control ofthe Company or laboratory will cause orhave caused development ofscientifically invalid data EPA will notifY the Company ofits response, in writing, within 4 weeks ofreceiving the Company's report. EPA's written response may either: (i) allow the Companyto continue to manufacture and import the PMN substances beyond the applicable production limit, or (ii) require the Company to continue to conduct, orto reconduct, the study in compliance with paragraphs (b), (c), and (e)(1) and (2), Ifthere is sufficient time to conduct or reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Company to comply with subparagraph (e)(3), the Company may exceedthe production limit and shall submit the report and data in triplicate to EPA within a reasonable period oftime, all as specified by EPA in the notice described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data, as to whether the Company may continue to manufacture and import beyond the applicable production limit.9



### G) Umeasonable Risk. (1) EPAmay notify ):he Company in writing that EPA finds thatthe data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substances will or may present an umeasonablerisk ofinjury to human health orthe environment. EPA's notice may specify that the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use andior disposal ofthe PMN substances to mitigate exposures to or to better characterize the risks presented by the PMN substances. Within 2 weeks from receiptofsuch a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substances, unless either: (2) within 2 weeks from receipt ofthe notice described in subparagraph 

### G)(l), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks fromreceipt ofthe notice described in subparagraph 

### G)(l), the Company submits to EPA a written report refuting EPA's finding andiorthe appropriateness of any additional requirements imposedby EPA. The Company may continue to manufacture, import, process, distribute, use and dispose ofthe PMN substances in accordance with the terms of this Order pendingEPA's response to the Company's written report. EPAwill respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks of receipt ofEPA's written response, the Company shall comply with anyrequirements imposed by EPA's response orcease all manufacture, import, processing, distribution, use and disposal ofthe PMN substances.

### 10
(k) Other Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continueto obey allthe tenns ofthis Consent Order until otherwise notified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modify orrevoke provisions ofthis Consent Order pursuant to Part VI ofthis Consent Order.

PROTECTION IN THE WORKPLACE 

### (a) Establishment ofProgram. Duringmanufacturing, processing, and use ofthe PMN substances at any site controlledbythe Company (including any associated packaging and storage and during any cleaning ormaintenance ofequipment associated with the PMN substances), the Company must establish a program whereby: (1) General Dennal Protection. Each person who is reasonably likely to be dennally exposedin the work areato the PMN substances through direct handling ofthe substances or through contact with equipment on which the substances may exist, or because the substances become airborne in a fonn listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, personal protective equipment thatprovides a barrier to prevent dennal exposure to the substances inthe specific work area where the substances are selected for use. Each such item ofpersonal protective equipment must be selected and used in accordance with OSHA dermal protectionrequirements at 29 CFR 1910.132, 1910.133, and 1910.138.
(2) Specific Dermal Protective Equipment. The dennal personal protective equipment required by subparagraph (a)(l) ofthis section must include, but is not limited to, the following

### 11 items: (i) Gloves impervious to the PMN substances (ii) Clothing that covers any other exposed areas ofthe arms, legs, and torso (3) Demonstration ofImperviousness. The Company is able to demonstrate that the gloves selected provide an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within the work areaby anyone or a combination ofthe following: (i) Permeation Testing. Testing the material used to make the gloves and the construction ofthe gloves to establishthatthe protective gloves will be impervious for the expected duration and conditions ofexposure. Thetesting must subjectthe chemical protective gloves to the expected conditions ofexposure, including the likely combinations ofchemical substances to which the gloves maybe exposed in the work area. Permeationtesting shall be conducted accordingto the American Society for Testing and Materials ("ASTM") F739 "Standard Test Method for Resistance ofProtective Clothing materials to Permeationby Liquids
or Gases." Results shall be recorded as a cumulative permeationrate as a function oftime, and shall be documented inaccordance with ASTM F739 using the format specified inASTM F1194- 89 "Guide for Documenting the Results ofChemical Permeation Testing on Protective Clothing Materials." Gloves may not be usedfor a time period longer than they are actually tested and must be replaced atthe end ofeach work shift duringwhichthey are exposed to the PMN substances. (ii) Manufacturer's Specifications. Evaluating the specifications from the manufacturer or supplier ofthe chemical protective gloves to establish that the chemical protective gloves will be impervious to the PMN substances alone and in likely combination with other chemical substances in the work area.12 (4) Respiratory Protection. Each person who is reasonably likely to be exposed by inhalation inthe work area to the PMN substances in the fonn listed in subparagraph (a)(5) ofthis section, is provided with, andis required to wear, at a minimum, a NIOSH-certifiedrespirator from the respirators listed in subparagraph (a)(6) ofthis section, and the respirator is used in accordance with the Occupational Safety and Health Administration ("OSHA") and NIOSH respiratory protectionrequirements at 29 CFR 1910.134 and 42 CFR Part 84. All respirators must be issued, used, and maintained according to an appropriate respiratory protection program under the OSHA requirements in 29 CFR 1910.134. (5) Physical States. The following physical states ofairborne chemical substances are listed for subparagraphs (a)(l) and (4) ofthis section: (i) Particulate (including solids or liquid droplets). (6) Authorized Respirators. The following NIOSH-certified respirators meet the minimumrequirements for subparagraph (a)(4) ofthis section: NIOSH-certified airpurifying, tight-fitting full-face respirator equipped with N100 cartridges.

MANUFACTURING (a)(I) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import ofthe PMN substances by any otherperson. (2) Sunset Following SNUR. Subparagraph (a)(I) shall expire 75 days after promulgation ofa final significant new use rule ("SNUR") governing the PMN substances under section 5(a)(2) of TSCA unless the Company is notified on orbefore that day ofan action in a Federal Court seeking judicial review ofthe SNVR. Ifthe Company is so notified, subparagraph (a)(l) shall not expire until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have

### 13 been resolved and the validity ofthe SNUR affirmed. (3) Notice ofSNUR. When EPA promulgates a final SNUR for the PMN substances and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notifY each person whom it causes, encourages or suggests to manufacture orimportthe PMN substances of the existence ofthe SNUR.
(b) Prohibited Uses. The Company shall notmanufacture or import the PMN substances for use otherthan as: (l) an intermediate compound for use in producing downstream products that will in turn be used in organic electronic devices and an additive to improve mechanical properties or conductivity; (2) a compoundusedtoimprove the mechanical properties ofrubbers, plastics, and lubricants; and (3) a compound for use as an additive to increase the conductivity ofmaterials. The Company shall not mix ormanufacture the PMN substance to encapsulate another chemical substance.


### PROCESSING AND USE The Company shall not proeess oruse the PMN substances other than as: (l) an intermediate compound for use inproducing downstream products that will in turn be used in organic electronic devices and an additive to improve mechanical properties or conductivity; (2)
a compound used to improve the mechanical properties ofrubbers, plastics, and lubricants; and (3) a compound for use as an additive to increase the conductivity of materials. The Company shall not mix, process, or use the PMN substance to encapsulate another chemical substance.14 DISTRIBUTION (a) ExportNotice Requirement. No later than the date ofdistribution, the Company shall notify in writing any person to whom it distributes the PMN substances (a Distributee) that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substances are subject to the export notification requirements ofTSCA section 12(b) and 40 CFRPart 707 Subpart D. Such notice shall contain, in the form in which they appear in the Consent Order, the following information: (1) the PMNnumbers and (2) either (A) the specific chemical identities ofthe chemical substances, or (B) ifthe specific chemical identities are confidential, the generic chemical identities.
(b) Types ofDistributees. This Distribution section authorizes the Companyto distribute the PMN substances to three types ofDistributees: (1) Distributees who will further distribute the PMN substances only when the PMN substances are in a mitigated state, as defined inparagraph (c); (2) Distributees who will further distribute the PMN substances in anunmitigated state before the attached Consent Order for Processor expires 75 days after promulgation ofa final SNUR goveming all ofthe PMN substances; and (3) Distributees who will further distribute the PMN substances in an unmitigated state after the attached Consent Order for Processor expires 75 days after promulgation ofa final SNUR governing all ofthe PMN substances. The distribution requirements for the first and third type ofDistributee are identical and are stated in paragraph (e) below. The second type ofDistributee must sign the attached Consent Order for Processor, as 

### specified in paragraph (f) 

### below.15 (c) Mitigated States ofthe PMN Substances. For purposes offurther distribution, the PMN substances shall be considered to be in a "mitigated state" (regarding risk) when the PMN substances have been (i) completelyreacted (cured); (ii) incorporated or embedded into a polymer matrix that itselfhas been reacted (cured); (iii) embedded 

### in apermanent solid polymer form that is not intended to undergo further processing except for mechanical processing; or (iv) incorporated into an article as defined at40 CFR nO.3(c).
(d) TemporaryTransport and Storage. Notwithstanding paragraphs (e) and 

### (t) in this Distribution section, the Company may distribute the PMN substances outside the Company for temporary transport and storage insealed containers provided the following two conditions are met: (1) Subsequentto any such exempttemporary transport or storage ofsealed containers, the PMN substances may be distributed only to the Company or to a Distributee compliant with paragraph (e) or 

### (t). (2) Any human exposure or environmental release resulting from opening the. sealed containers and removing or washing out the PMN substances may occur only while the PMN substances are in the possession and control ofthe Company or a Distributee compliant with paragraph (e) or 

### (t).
(e) Distribution Requirements inthe Absence ofProcessor Order. Except when the PMN substances are in a mitigated state as described in paragraph (c) above, or as provided in the Temporary Transport and Storage paragraph (d) above, or for Distributees who sign Processor Orders as described in paragraph 

### (t) below, the Company shall distribute the PMN substance16 outside the Company, other than for disposal, only to a Distributee who has agreed in writing prior to the date ofdistribution, to: (1) Notify in writing anyperson to whom itdistributes the PMN substance that, due to the issuance ofthis Consent Orderunder section 5(e) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section l2(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, inthe form in which it appears inthis Consent Order, the following information: (1) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Not further distribute the PMN substances to any other person, other than for disposal, except when the PMN substances are in a mitigated state, as described inparagraph (c) above. (3) Comply with the same requirements and restrictions required ofthe Company in the Protectioninthe Workplace section; (4) Comply with the same requirements and restrictions required ofthe Company inthe Release to Water section ofthis Order; and (5) Notprocess or use the PMN substances otherthan as: (1) an intermediate compound for use inproducing downstream products that will in tum be used in organic electronic devices and an additive to improve mechanical properties or conductivity; (2) a compound used to improve the mechanical properties ofrubbers, plastics, and lubricants; and (3) a compound for use as an additive to increase the conductivity ofmaterials; (6) Not mix, process, or use the PMN substance to encapsulate another chemical Subst!='ll1ce.17 

### (1) Consent Order for Processor. (1) Ifthe Company distributes the PMN substances to Distributees who will further distribute the PMN substances in an unmitigated state, before the attached Consent Orderfor Processor expires 75 days after promulgation ofa final SNUR governing all ofthe PMN substances, the Company shall distribute the PMN substances outside the Company, other than for disposal, only to a Distributee who has signed the Consent Order for Processor inAttachment C to this Order (a "Processor"). (2) The Company shall obtain from each such Processor a signed copy ofthe Consent Order for Processor and submit the copy to EPA along withthe name, address, and telephone number ofa responsible official ofthe Processor. The Processor orCompany must receive a fully executed copy ofthe Consent Order for Processor from EPA before the Processor maybeginto process any ofthe PMN substances.
(g) Sunset following SNUR. (1) Ifthe Company distributes the PMN substances to Distributees who will further distribute the PMN substances in an unmitigated state, before the attached Consent Order for Processor expires 75 days after promulgation ofa final SNUR governing all ofthe PMN substances, the Company shall distribute the PMN substances, other than for disposal, only to processors who have signed the attached Consent Order for Processor in accordance with paragraph 

### (1) ofthis Distribution section. After the attached Consent Order for Processor expires 75 days a..fter promulgation ofa final SNUR governing all ofthe PMN substances, the Company shall distribute the PMN substances only to Distributees who comply with the requirements specified inparagraph (e) ofthis Distribution section.

### 18 (2) Paragraphs (e)(2) and (f) ofthis Distribution section shall expire 75 days after promulgation ofa final SNUR for the PMN substances under section 5(a)(2) ofTSCA, unless the Company is notified on orbefore that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Company is so notified, paragraphs (e)(2) and (f) 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 affirmed. (3) When.EPA promulgates a final SNUR for the PMN substances and paragraph (e)(2) and (f) ofthis Distribution section expires in accordance with subparagraph (g)(2), the Company shall notify each Distributee to whom it distributes the PMN substances ofthe existence ofthe SNUR. Suchnotification must be in writing and must specifically include all limitations contained inthe SNUR which are defined as significant new uses, and which would invoke significant new
use notification to EPA for the PMN substances. Suchnotice must also reference the publication ofthe SNUR for these PMN substances in eitherthe Federal Register orthe Code ofFederal Regulations. After promulgation ofa SNUR and expiration ofparagraphs (e)(2) and (f), such notice may substitute for the written agreement required in the introductory clause ofparagraph (f); so that, ifthe Companyprovides such notice to the Distributee, thenthe Company is not required to obtain from such Distributeethe written agreement specified

### in paragraph (e). However, even absent such written agreement, the Companyremains obligated to comply withthe "RecipientNon-Compliance" paragraph (h) below.
(h) Recipient Non-Compliance. If, at any time after commencing distribution in commerce ofthe PMN substances, the Company obtains knowledge that a recipient (including a Processor) ofthe PMN substances has failed to complywith any ofthe applicable conditions specified inparagraphs19 (e)(2) or (f) ofthis Distribution section or, after paragraphs (e)(2) or (f) expires iu accordance with paragraph (g)(2), has engaged in a significant newuse ofthe PMN substances (as defined in 40 CFRPart 721, SubpartE) without submitting a significant newuse notice to EPA, the Company shall cease supplying the substancesto that recipient, unless the Company is able to document each ofthe following: (1) Thatthe Company has, within 5 working days, notified the recipient in writing that the recipienthas failed to comply with any ofthe applicable conditions specified inparagraphs (e)(2)
or (f) ofthis Distribution section, orhas engaged in a significant new use ofthe PMN substances without submitting a significant newuse notice to EPA. (2) That, within 15 working days ofnotifYing the recipient ofthe noncompliance, the Companyreceived from the recipient, inwriting, a statement ofassurance that the recipient is
aware ofthe applicable terms ofparagraphs (e)(2) or (f) ofthis Distribution section and will comply withthose terms, or is aware ofthe terms ofthe significant newuse rule for the PMN substances and will not engage ina significant newuse without submitting a significant new use notice to EPA. (3) If, after receiving a statement ofassurance from a recipient under subparagraph (h)(2) ofthis Distribution section, the Company obtains knowledge that the recipient has failed to comply with any ofthe applicable conditions specifiedinparagraphs (e)(2) or (f) ofthis Distribution section, orhas engaged in a significantnewuse ofthe PMN substances without submitting a significantnewuse notice to EPA, the Company shall cease supplying the PMN substances to that recipient, shall notify EPA ofthe failure to comply, and shall resume supplying the PMN substances to that recipient only upon written notification from the Agency.20 

### RELEASE TO

### WATER This provision does not supercede orpreempt any applicable federal, state, or local laws andregulations. Those may be more stringent than therequirements below. The Processor is prohibited from anypredictable orpurposeful release ofthe PMN substance, or any waste stream from processing or use containing the PMN substance, into the waters ofthe United States.



### III. RECORDKEEPING (a) Records. The Company shall maintainthe following records until 5 years after the date they
are created and shall make them available for inspection and copying by EPA 

### in accordance with section 11 ofTSCA: (I) Exemptions. Records documenting that the PMN substances did infact qualify for any
one ormore ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed bythe Company. Any amounts or batches ofthe PMN substances eligible for the Export 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, copies ofthe export label and export notice to EPA, required byTSCA sections 12(a)(l)(B) and l2(b), respectively. Any amounts or batches ofthe PMN substances eligible for the Research and Development exemption in Section I, Paragraph (b)(3) ofthis Order,
are exemptfrom all the requirements inthis Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records required by 40 CFR nO.78(b). For any amounts or batches ofthe PMN substances claimedto be eligible for any other exemption

### 21 described in Section I, Paragraph (b) ofthis Order, the Company shall keep records demonstrating qualification for that exemption as well as the records specified inparagraphs (2) and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importation volume ofthe PMN substances and the corresponding dates ofmanufacture and import; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Company directly sells ortransfers the PMN substances, the date ofeach sale ortransfer, and the quantity of the substances sold ortransferred on such date; (4) Records documenting the addresses ofall sites ofmanufacture, import, processing, and use; (5) Records documenting establishment and implementation ofa program for the use of any applicable personal protective equipmentrequired pursuant to the Protection inthe Workplace section ofthis Order; (6) Records documenting the determinations required by the Protection in the Workplace section ofthis Order that chemical protective clothing is impervious to the PMN substances; (7) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, and Use, and Distribution sections ofthis Order, including any Consent Order for processors and distributees' written agreement to comply with the Distribution section ofthis Order;
(8) Records documenting establishment and implementation ofprocedures that ensure compliance with any applicable water discharge limitation in the Release to Water section ofthis

### 22 Order; (9) Copies ofany Transfer Documents and notices required by the Successor Liability section ofthis Order, ifapplicable; and (l0) The Company shall keep a copy ofthis Order at each ofits sites where the PMN substances are manufactured ofimported.
(a) Applicability. Theprovisions ofthis Recordkeeping Section are applicable only to activities ofthe Company and not to activities ofthe Company's customers.
(b) OMB Control Number. Underthe Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is not ·required to respond to this"collection of information" unless this Order displays a currently valid control number from the Office of Management and Budget ("OMB"), and EPA so informs the Company. The "collection of information"required in this TSCA §5(e) Consent Orders has been approved under currently valid OMB ControlNumber 2070-0012.

IV. REQUESTS FORPRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section II ofTSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyances associated with the PMN substances. To facilitate such inspections, EPA personnel may contact the Company in advance to request information pertinent to the scheduling and conduct ofsuch inspections. Such requests may be written or oral. The types ofinformation that EPA may request may include, but are not limited to, the following:23 (i) Expected dates and times whenthe PMN substances will be inproduction withinthe subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with the PMN substances and mayreasonably be exposedto the PMN substances; (iii) Currentjobtitles or categories for workers who are involved in activities associated with the PMN substances and may reasonably be exposedto the PMN substances; (iv) Existing exposure monitoring data for workers who are involvedin activities associated with the PMN substances and may reasonablybe exposed to the PMN substances; (v) Records required bythe Recordkeeping section ofthis Order; and/or (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for thatpurpose.
(b) Company's Response. The Company shall respondto such requests within a reasonable period oftime, but inno event later than 30.days after receiving EPA's request. When requested in writingby EPA, the Company's response shall be inwriting. To the. extentthe information is knownto orreasonably ascertainable to the Company atthe time ofthe request, the Company's response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests. (c) Confidential Business Information. Any Confidential Business Information ("CBI") that the Company submits to EPApursuant to paragraph (b) shall beprotected in accordance with 

### §14 of TSCA a.lld 40 CFRPart2.24 

### V. SUCCESSORLIABILITYUPONTRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures bywhich the Company's rights and obligations under this Order may be transferred whenthe Company transfers its interests in the PMN substances, including the right to manufacture the PMN substances, to another person outside the Company (the "Successor in Interest").


### (b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Company to the Successorin Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import (,'NOC") for the PMN substances from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit.
newPMNs to EPA and comply fully with Section 5(a)(1) ofTSCA and 40 CFRpart 720 before commencing manufacture or import ofthe PMN substances. (2) AfterNOC. Ifthe transfer from the Company to the Successor in Interest is effective after EPA receives a NOC, the Successor in Interest shall comply with the terms ofthis Order and shall notbe required to submit new PMNs toEP 

### A.
(c) Definitions. The following definitions apply to this Successor Liability section ofthe Order: (1) "Successorin Interest" means a person outside the Company who has acquired the Company's full interest in the rights to manufacture the PMN substances, including all ownership rights and legal liabilities, through a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Company in the PMN substances, such as a licensee who has acquired a limited license to the patent or manufacturing rights associated withthe.PMN substances. A Successor in25 Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR720.22(a)(3). (2) "Transfer Document"means the legal instrnment(s) used to convey the interests in the PMN substances, including the right to manufacture the PMN substances, from the Company to the Successor in Interest.
(d) Notices. (I) Notice to Successor in Interest. On orbeforethe effective date ofthetransfer, the Company shall provide to the Successor in Interest, by registered mail, a copy ofthe Consent Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the Company shall, by registered mail, submit the fully executedNotice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer DocUment. Copies ofthe Transfer Documentmust 

### be maintained by the Successor**~n** Interest at its principal place ofbusiness, and at all sites where the PMN substances
are manufactured or imported. Copies ofthe Transfer Document must also be made available for inspection pursuantto Section 11 ofTSCA, must state the effective date oftransfer, and must contain provisions which expressly transfer liability for the PMN substances under the terms of this Order from the Companyto the Successor in Interest.

### 26 (e) Liability. (1) The Company shall be liable for compliance withthe requirements ofthis Order until the effective date ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date oftransfer. (3) Nothing in this section shall be construed to prohibitthe Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, or omissions made, during the time in which the Company manufactured, processed, used, distributed in commerce, ordisposed ofthe PMN substances pursuant to the terms ofthis ConsentOrder.
(f) Obligations to Submit TestDataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Order requires the Companyto submittest datato EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMN substances manufactured and imported bythe Company up to the date of transfer shall counttowards the testtriggerapplicable to the Successor in Interest.27 VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company maypetition EPA at any time, based upon new information onthe human health orenvironmental effects of, orhuman exposure to or environmental release of, the PMN substances, to modifY orrevoke substantiveprovisions ofthis Order, including modifYing the Release to Waterprovisions to allowlimited releases to water. The exposures and risks identified by EPA during its review ofthe PMN substances andthe information EPA determined

### to be necessary to evaluate those exposures and risks are described inthe preamble to this Order. However, in determining whetherto amend orrevoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessment ofthe test data or other information that supports the findings inthis Order, an examination ofnewtestdata or other information oranalysis, 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 human exposure or substantial environmental release inthe absence ofdata sufficient to permit a reasoned evaluation ofthe health orenvironmental effects of the PMN substances. In addition, the Company may petition EPA at any time to make other modifications 

### to the language ofthis Order. EPAwill issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.28 

### VII. EFFECT OF CONSENT ORDER Byconsenting to the entryofthis Order, the Companywaives its rights to file objections to this Orderpursuantto section 5( e)(1)(C) ofTSCA, to receive service ofthis Orderno laterthan45 days beforethe end ofthe review periodpursuantto section 5(e)(I)(B) ofTSCA, and to challenge the validity ofthis Orderinany subsequentaction. Consentingto the entry ofthis Order, and agreeing to beboundbyits terms, donot constitUte an admission bythe Company as to, the facts
or conclusions underlying the Agency's determinations inthis proceeding. This waiver does not affect any other**ri~~** thatthe CompanymayhaveunderTSCA. Bysigningthis Order, the 

# , Companyrepresents thatithas carefullyreviewed this document andhereby agrees that all informationherein that is claimed as confidentialbythe Company (per section 14ofTSCA, 40 CFRPart 720 Subpart E, and40 CFRPart2) is correctlyidentifiedwithinbrackets <kd that any informationthat isnotbracketed isnot claimed as confidential. Tomakethis document available forpublicviewing, EPA will removeonlytheinform ained 

### within thebrackets.

Date s, Drrector I Control Division ofPollution Prevention and Toxics

Date Company: Nano-C, Inc.ATTACHMENTA DEFINITIONS [Note: The attachedOrder may notcontain some ojthe terms definedbelow.] "Chemical name" means the scientific designation ofa chemical substances in accordance with the nomenclature system developedbythe International Union ofPure and Applied Chemistry or the Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identifY a chemical substances for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protective barrier to prevent dermal contact with chemical substances ofconcern. Examples can include, butare not limited to: full body protective clothing, boots, coveralls, gloves,jackets, and pants. "Company" means the person orpersons subject to this Order. "Commercial use" meansthe use ofa chemical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than by its chemicalname. "Consumer" means a private individual who uses a chemical substance or any product containing the chemical substance in or around a permanent ortemporary household orresidence, during recreation, orfor any personal use or enjoyment. "Consumerproduct" means a chemical substancethat is directly, or as part ofa mixture, sold ormade available to consumer1; for their use in oraFOund a permanent or temporary household orresidence, in or around a school, or inrecreation. "Container" means any bag, barrel, bottie, box, can, cylinder, drum, reaction vessel, storage tank, orthe like that contains a hazardous chemical. Forpurposes ofthis section, pipes or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are notconsidered to be containers. "ContritctManufacturer" means a person, outside the Company, who is authorized to manufacture and importthe PMN substance under the conditions specified in Part II. ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identifY a chemical substance or a mixture containing that substance. "Immediate use." A chemical substance is for the "immediateuse" ofa person ifit is under2 the control of, and used only by, the person who transferred it from a labeled container and will onlybe used bythat person within the work shift inwhich it is transferred from the labelled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical or mechanical degradation, permeation, orpenetration ofthe chemical protective clothingunderthe 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 ofdatafor the chemical substance.
. "NIOSH"meansthe National Institute for Occupational Safety and Health oftheU.S. Department ofHealth and Human Services. "Non-enclosedprocess" means any equipment system (such as an open-top reactor, storage tank, ormixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contactofthe bulk chemical substance and the workplace air may occur. "Non-industrial use" means use otherthan at a facility where chemicalsubstances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the Premanufacturenotice submittedbythe 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 inthe work area. Examples include, but are notlimited

### to, chemicalprotective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types ofrespirators. Barrier creams are not included inthis definition. "Process" means the preparation ofa chemical substance ormixture, after its manufacture, for distribution in commerce (A) inthe same form or physical state as, or in a different form or physical state from, that inwhich it was receivedbythe person so preparing such substance or mixture, or (B) as partofan article containing the chemical substanceormixture. "Processor" means the person orpersons subject to this Consent Order for Processor "Process stream"means all reasonably anticipated transfer, flow, ordisposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of processing, including the cleaning ofequipment.3
"Scientifically invalid" means any significant departure from the EPA-approved protocol or the Good Laboratory Practice Standards at 40 CFRPart 792 without prior or subsequent Agency approval that prevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. "Scientificallyequivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive,
. internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk ofinjury to humanhealth or the environment ofthe PMN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-term containment ofthe PMN substance, and from whichthere will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumer use, "Waters ofthe United States" has the meaning set f9rth 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 establishment at one geographic location containing one or more work areas.

### Company (Transferor) ATTACHMENT B NOTICE OFTRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION See) 

### CONSENT ORDER

PMNNumber 

### 1. 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 substances, which was the subject ofa preniannfacture notice ("PMN") and is governed by a Consent Order issued by the U.S. Environmental ProtectionAgency ("EPA") under the authority of §5(e) ofthe Toxic Substances Control Act (TSCA, 15 U.S.C. §2604(e». 2. Assumption ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting mannfacture, processing, use, distribution 

### incommerce and disposal ofthe PMN substances, shall be the responsibility ofthe Successor inInterest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in. accordance with40 CFR n0.22(a)(3). 3. Confidential Business Information. The Successor in Interest hereby:

_ reasserts,

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

TOXIC SUBSTANCES CONTROL ACT SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)
Company (Transferor) PMNNumber

Signature ofAuthorized Official Date
PrintedName ofAuthorized Official
Title ofAuthorized Official

Successorin Interest
Signature ofAuthorized Official Date
PrintedName ofAuthorized Official
Title ofAuthorized Official
Address City, State, Zip Code

### 3



### TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER NOTICE OFTRANSFER (continued)

Successor's Technical Contact


### Address City, State, Zip Code
PhoneATTACHMENT C
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OF NEW CHEMICAL SUBSTANCES PENDING DEVELOPMENT OF INFORMATION
Inthe matter of: ) ) ) 

### ) ) ) ) ) ) ) ) ) 

### ) ) 

### ) ) ) 

### ) ) ) ) ) ) ) ) ) Premanufacture Notice Numbers:

P-09-54 -57

Consent Order for Processor

### ii
TABLE OF CONTENTS Consent Order I. Scope ofApplicability and Exemptions 

### II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation 

### HI. Recordkeeping IV. Requests for Pre-Inspection Information V. Modification and Revocation ofConsent Order VI. Effect ofConsent Order AttachmentA

- Definitions

## CONSENT ORDER I. SCOPE, EXEMPTIONS AND TERMINATION (a) Scope. Therequirements ofthis Order apply to all commercial processing, distribution in commerce, use and disposal, in the United States, ofthe following chemical substances P-09-54- [5,6]Fullerene-C60-Ih, P-09-55

- [5,6]Fullerene-C70-D5h(6), P-09-56

- [5,6]Fullerene-C84-D2, P-09-57

- [5,6]Fullerene-C84-D2d, (the "PMN substances"), submitted by
_ ("the Company"), and processed by
_______("the Processor"), exceptto the extent that those activities are exemptedby paragraph 

### (b). This Order is an attachment to a related Order applying to the Company, which among otherrequirements, prohibits the Company from distributing the PMN substances, unless the have been (i) completelyreacted (cured); (ii) incorporated or embedded into a polymer matrix that itselfhas been reacted (cured); (iii) embeddedin a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing; or (iv) incorporated into an article as defined at 40 CFR nO.3(c), other than to those persons who have either: (I) agreed to and signed this Consent Order for Processor, or (2) agreed in writing to comply with similar requirements and restrictions as required of the Company in the Company's Consent Order.2 (b) Sunset Following SNUR. The Consent Order for Processor (exceptthe 5-yearrecordkeeping requirements in Section III ofthis Order) shall expire 75 days afterpromulgation ofa final significantnewuse rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA, unless the Processor is notified on orbefore that day ofan action in a Federal Court seeking judicial review ofthe SNUR. Ifthe Processor is so notified, the conditions shall notexpire until EPAnotifies the Processor inwriting that all Federal Court actions involving the SNURhave been resolved and the validity ofthe SNUR affirmed.
(c) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances are exempt from the requirements ofthis Order (exceptthe requirements inthe Recordkeeping section) only to the extentthat (1) these activities are conducted infull compliance with all applicable requirements ofthe following exemptions, and (2) suchcompliance is documentedby appropriate recordkeeping as required inthe Recordkeepingsection ofthis Order. (l) Mitigated States ofthe PMN Substances The requirements ofthis Order do not apply to quantities ofthe PMN substances thathave been (i) completely reacted (cured); (ii) incorporated
or embedded into a polymermatrixthat itselfhas been reacted (cured); (iii) embedded in a permanent solidpolymer form that is not intended to undergo further processing except for mechanicalprocessing; or (iv) incorporated into an article as defined at 40 CFR 720.3(c). (2) Export. Until the Processorbegins commercial processing ofthe PMN substances for
use inthe United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe PMN substances solely for export in accordance with TSCA §12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Processorbegins to processthe PMN substances for use inthe United States, no further activities bythe Processor

### 3 involving the PMN substances are exempt as "solely for export" even ifsome amounts ofthe PMN substances are later exported. Atthat point, the requirements ofthis Order apply to all activities associated with the PMN substances while in the territory ofthe United States. Prior to leaving U.S. territory, even those quantities or batches ofthe PMN substances that are destined for export
are subjectto terms ofthe Order, and counttowards any production volume test triggers in the Testing section ofthis Order. (3) Research & Development ("R&D"). The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances in small quantities solely for research and development in accordance withTSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CFR 720.36. (4) Byproducts. The requirements ofthis Order do not apply to the PMN substances when they are produced, without separate commercial intent, only as "byproducts" as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). (5) No Separate Commercial Purpose. The requirements ofthis Order do not apply to the PMN substances when they are manufactured, processed, distributed in commerce, used and/or disposedpursuant to any ofthe exemptions in 40 CFR 720JO(h), with no commercial purpose separate from the substances, mixture, or article ofwhich they are a part.4
II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTIONIN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSIONAND EVALUATION OF INFORMATION
PROIDBITION The Processor is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe PMN substances in the United States, for any nonexempt commercial purpose, pendingthe development ofinformation necessary for a reasoned evaluation ofthe human health effects ofthe substances, and the completion ofEPA's review of, and regulatory action based on, that information, except in accordance with the conditions described in this Order. TESTING (a) Section 8ee) Reporting. Any information on the PMN substances whichreasonably supports the conclusion thatthe PMN substances present a substantialrisk ofinjury tohealth or the environmentrequired to be reported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70 Federal Register 2162 (January 12, 2005), shall reference the appropriate PMN identification numbers for these substances and shallcontain a statement that the substances are subject to this Consent Order. Additional informationregarding section 8(e) reporting requirements can be found in the reporting guide referenced at 56 Federal Register 28458 (June 20, 1991).

PROTECTION IN THE WORKPLACE (a) Establishment ofPrograrn. Duringprocessing and use ofthe PMN substances at any site

### 5 controlled by the Processor (including any associated packaging and storage and during any cleaning or maintenance ofequipment associated with the PMN substances), the Processor must establish a program whereby: (1) General Dermal Protection. Eachperson who is reasonably likely to be dermally exposed 

### inthe work area to the PMN substances through direct handling ofthe substances or through contact with equipment on which the substances may exist, orbecausethe substances become airborne in a form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, personal protective equipment that provides a barrier to prevent dernial exposure to the substances in the specific work area where the substances are selected for use. Each such item ofpersonal protective equipmentmustbe selected and used in accordance with OSHA dermal protection requirements at 29 CFR 1910.132, 1910.133, and 1910.138. (2) Specific Dermal Protective Eguipment. The dermal personal protective equipment required by subparagraph (a)(l) ofthis section must include, butis not limited to, the following items: (i) Gloves impervious to the PMN substances (ii) Clothing that covers any other exposed areas ofthe arms, legs, and torso. (3) Demonstration ofImperviousness. The Processor is able to demonstrate that any gloves selectedprovide an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within the work area by anyone or a combination of the 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 the6 chemical protective clothing to the expected conditions ofexposure, including the likely combinations ofchemical substances to which the clothing may be exposed in the work area. Permeation testing shall be conduded according to the American Society for Testing and Materials ("ASTM") F739 "Standard Test Method for Resistance ofProtective Clothing materials to Permeation by Liquids or Gases." Results shall be recorded as a cumulative permeation rate as a function oftime, and shall be documented in accordance with ASTM F739 using the format specified in ASTMFl194-89 "Guide for Documenting the Results ofChemical Permeation Testing on Protective Clothing Materials." Gloves may not be 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 substances. (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 substances alone and inlikely combination with other chemical substances in the work
area. (4) Respiratory Protection. Each person who is reasonably likelyto be exposed by inhalation in the work areato the PMNsubstances in the form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, at a minimum, a NIOSH-certified respirator from the respirators listed in subparagraph (a)(6) ofthis section, and the respirator is used inaccordance with the Occupational Safety and Health Administration ("OSHA") andNIOSH respiratory· protectionrequirements at 29 CFR 1910.134 and 42 CFRPart 84. All respirators must be issued, used, and maintained according to an appropriate respiratory protection program under the OSHA requirements in 29 CFR 1910.134.7 (5) Physical States. The following physical states ofairborne chemical substances are listed for subparagraphs (a)(J) and (4) ofthis'section: (i) Particulate (including solids orliquid droplets). (6) Authorized Respirators. The following NIOSH-certified respirators meetthe minimum requirements for subparagraph (a)(4) ofthis section: NIOSH-certified airpurifying, tight-fitting full-face respirator equipped with NIOO cartridges.

MANUFACTURING (a)(1) Prohibition. The Processor shall not manufacture the PMN substances, or cause, encourage,
or suggestthe manufacture orimport, ofthe PMNsubstances by any person other than the Company.

PROCESSING AND USE The Processor shall not process or use the PMN substances other than as: (1) anintermediate compound for use in producing downstream products that will in turn beused in organic electronic devices and an additive to improve mechanical properties or conductivity; (2) a compound used to improvethe mechanical properties of rubbers, plastics, and lubricants; and (3) a compound for use
as an additive to increase the conductivity ofmaterials. The Processor shall not mix, process or
use the PMN substance to encapsulate another chemical substance.

DISTRIBUTION (a) ExportNotice Reguirement. No later than the date ofdistribution, the Processor shall notify in8 writing any person to whom it distributes the PMN substances that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substances are subject to the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in the form in which they appear in the Consent Order, the following information: (1) the PMN numbers and (2) either (A) the specific chemical identities ofthe chemical substances, or (B) ifthe specific chemical identities are confidential, the generic chemical identities.
(b) Mitigated States ofthe PMN Substances. For purposes offurther distribution, the PMN substances shall be considered to be in a "mitigated state" (regarding risk) when the PMN substances are: (i) completely reacted (cured); (ii) incorporated or embeddedinto a polymer matrix that itselfhas been reacted (cured); (iii) embedded in a permanent solid polymer form that is not intended to undergo further processing except for mechanical processing, or (iv) incorporated into
an article as defined at40 CFR nO.3( c).
(c) Temporary Transportand Storage. Notwithstanding paragraph (d) in this Distribution section, the Processor may distribute the PMN substances outside theProcessor for temporary transport and storage in sealed containers provided the following two conditions aremet: (1) Subsequent to any such exempt temporary transport or storage ofsealed containers, the PMN substances may be distributed only to the Company or to a Distributee compliant with paragraph (d). (2) Anyhuman exposure or environmental release resulting from opening the sealed containers and removing or washing outthe PMN substances may occur only while the PMN9 substances are inthe possession and control ofthe Company or a Distributee compliant with paragraph (d).
(d) Distribution Requirements. Except when the PMN substances are in a mitigated state as described in paragraph (b) above, oras provided in the Temporary Transport and Storage paragraph (c) above, the Processor shall distribute the PMN substances outside the Processor's company, other than for disposal, onlyto the Company or a person ("Distributee") who has agreed inwriting prior to the date ofdistribution, to: (I) Notify in writing any personto whom it distributes the PMN substance that, due to the issuance ofthis Consent Order under section 5(e) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section 12(b) and 40 CFRPart 707 Subpart D. Such notice shall contain, in the form in which it appears in this Consent Order, the following information: 

### (I) the pMN number, and (2) either (A) the specific chemical identity ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Notfurther distribute the PMN substances to any other person, otherthan for disposal, except when the PMN substances are in a mitigated state, as described in paragraph (b) above. (3) Comply with the same requirements and restrictions required ofthe Processor in the Protection in the Workplace section. (4) Comply with the same requirements and restrictions required ofthe Processor 

### in the Release to Water section ofthis Order. (5) Notprocess oruse the PMN substances otherthan as: 

### (I) an intermediate compound for use in producing downstream products that will in turn be used in organic electronic devices and an additive to improve mechanical properties or conductivity; (2) a compound used to improve10 the mechanical properties ofrubbers, plastics, and lubricants; and (3) a compound for use as an additive to increase the conductivity ofmaterials. (6) Notmix, process, or use the PMN substance to encapsulate another chemical substance.
(e) RecipientNon-Compliance. If, at any time after commencing distribution in commerce ofthe PMN substances, the Processor obtains knowledge that a recipient ofthe substances have failed to comply with any ofthe conditions specified inparagraph (d) ofthis Distribution section, the Processor shall cease supplying the substances to that recipient, unless the Processor is able to document each ofthe following: (1) That the Processor has, within 5 working days, notified the recipient in writing thatthe recipienthas failed to comply with any ofthe conditions specified in paragraph (d) ofthis Distribution section, or has engaged in a significant newuse ofthe PMN substances without submitting a significant new use notice to EPA. (2) That, within 15 working days ofnotifying the recipient ofthe noncompliance, the Processorreceived from the recipient, in writing, a statement ofassurance thatthe recipient is
aware ofthe terms ofparagraph (d) ofthis Distribution section and will comply with those terms,
or is aware oftheterms ofthe significantnew use rule for the PMN substances and will not engage in a significant newuse without submitting a significant new use notice to EPA. (3) If, after receiving a statement ofassurance from a recipient under subparagraph (e)(2) ofthis Distribution section, the Processorobtains knowledge that the recipienthas failed to comply with any ofthe conditions specified inparagraph (d) ofthis Distribution section, the Processor shall cease supplying the PMN substances to thatrecipient, shall notify EPA ofthe failure to comply, and shall resume supplying the PMN substances to that recipient only uponwritten11 notification from the Agency.


### RELEASE TO 

### WATER This provision does not supercede orpreempt any applicable federal, state, or local laws and regulations. Those may bemore stringent thanthe requirements below. The Processor is prohibited from any predictable orpurposeful release ofthe PMN substance, or any waste stream from processing oruse containing the PMN substance, into the waters ofthe United States.



### III. RECORDKEEPING (a) Records. The Processor shall maintain the following records until 5 years after the date they
are created and shall make them available for inspection and copying by EPA in accordance with section 11 ofTSCA:, (I)Exemptions. Records documenting that the PMN substancesdid in fact qualify for anyone or
more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed by the Processor. Any amounts orbatches ofthe PMN substances eligible for the Export exemption in Section I, Paragraph (b)(2) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Processor maintains, for 5 years from the date of their creation, copies ofthe export label and export notice to EPA, required byTSCA sections 12(a)(l)(B) and 12(b), respectively.-Any amounts orbatches ofthe PMN substances eligible for the Research and Development exemption in Section I, Paragraph (b)(3) ofthis Order, are exempt from all the requirements in this Recordkeeping section, ifthe Processor maintains, for 5 years12 from the date oftheir creation, the records required by 40 CFR nO.78(b). For any amounts or batches ofthe PMN substances claimed to be eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the Processor shall keep records demonstrating qualification for that exemption as well as the records specified in paragraph (2) below, butis exempt from the other recordkeeping requirements inthis Recordkeeping section; (2) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Processor directly sells or transfers the PMN substances, the date ofeach sale ortransfer, and the quantity of the substances sold or transferred on such date; (3) Records documenting the addresses ofall sites ofprocessing and use; (4) Records documenting establishment and implementation ofa program for the use of any applicable personal protective equipment required pursuant to the Protection inthe Workplace section ofthis Order; (5) Records documenting the determinations required by the Protection inthe Workplace section ofthis Order that chemical protective clothing is impervious to the PMN sUbstances; (6) Records documenting compliance with any applicablemanufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, and Use, and Distribution sections ofthis Order, including distributees' written agreement to comply withthe Distribution section of this Order; (7) Records documenting establishment and implementation ofprocedures that ensure compliance with any applicable water discharge limitation in the Release to Water section ofthis Order; and (8) The Processor shall keep a copy ofthis Consent Order for Processor at each ofits sites13 where the PMN substances are processed.
(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Processor, and not to activities ofthe Processor's customers.
(c) OMB Control Number. Underthe Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Processor is not required to respond to this "collection of information" unless this Order displays a currently valid control numberfrom the Office of Management and Budget ("OMB"), and EPA so informs the Processor. The "collection of information" required inthis TSCA §5(e) Consent Orders hasbeen approved under currently valid OMB Control Number 2070-0012.

IV. REQUESTS FORPRE-INSPECTIONINFORMATION (a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofProcessor facilities and conveyances associated with the PMN substances. To facilitate such inspections, EPApersonnel may contact the Processor in advance to request informationpertinentto the scheduling and conduct ofsuch inspections. Suchrequests may be written or oral. The types ofinformationthat EPA may request may include, but are not limited to, the following: (i) Expected dates and times whenthe PMN substances will be processed within the subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with14 the PMN substances and may reasonably be exposed to the PMN substances; (iii) Currentjobtitles or categories for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to the PMN substances; (iv) Existing exposure monitoring data for workers who are involved inactivities associated with the PMN substances and may reasonably be exposed to the PMN substances; (v) Records required bythe Recordkeeping section ofthis Order; and/or (vi) Any other informationreasonably related to determining compliance with this Order or conducting an inspection fot thatpurpose.
(b) Processor's Response. The Processor shall respond to such requests within a reasonable period oftime,but in no event later than 30 days after receiving EPA's request. When requested in writing by EPA, the Processor's response shall be in writing. To the extent the information is known to or reasonably ascertainable to the Processor at the time ofthe request, the Processor's response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests.
(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the Processor submits to EPA pursuant to paragraph (b) shall be protected in accordance with 

### §14 of TSCA and 40 CFRPart 2.



### V. MODIFICATION AND REVOCATION OF CONSENT ORDER The conditions ofthis Order (excepttheprovisions regarding the retention ofrecords described in III(a), the Recordkeeping section) shall expire 75 days after promulgation ofa final15 significant newuse rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA, unless the Processor is notified on orbefore that day ofan action in a Federal Court seeking judicial review ofthe SNUR. Ifthe Processor is so notified, the conditions shall not expire until EPA notifies the Processor in writing that all Federal Court actions involving the SNURhave been resolved and the validity ofthe SNURaffirmed. Prior to the promulgation ofthe final SNUR, the Processor may petitionEPA at any time, based upon new information onthe human health or enviromnental effects of, or !Juman exposure to or environmental release of, the PMN substances, to modify or revoke substantive provisions of this Order, including modifying the Release to Water provisions to allow limited releases to water. The exposures and risks identified by EPA during its review ofthe PMN substances and the information EPA determined to be necessary to evaluate those exposures and risks are described in
. the preamble to this Order. However, in determining whether to amend orrevoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, 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 other relevant information. EPA will issue a modification or revocation ifEPA determines thatthe activities proposed therein will notpresent an unreasonable risk ofinjury to health orthe environment and will not result in significant or substantial human exposure or substantial environmentalrelease in the absence ofdata sufficient to permit a reasoned evaluation ofthe health or environmental effects of the PMN substances. In addition, the Processor may petition EPA at any time to make other modifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the16 modification is useful, appropriate, 

### and consistent withthe structure 

### and intent ofthis Order as issued.17 

### VI. EFFECT OF 

### CONSENT ORDER By consenting to the entry ofthis Order, the Processor waives its rights to file objections to this Order pursuant 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)(I)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound by its tenns, do notconstitute an admission by the Processor as to, the facts
or conclusions underlying the Agency's detenninations inthis proceeding. This waiver does not affect any other rights that the Processormay have under TSCA. By signing this Order, the Processorrepresents that it has carefully reviewed this document and hereby agrees that all infonnation hereinthat is claimed as confidential by the Processor (per section 14 ofTSCA, 40 CFRPart 720 SubpartE, and 40 CFRPart 2) is correctlyidentified within brackets and that any infonnationthat is not bracketed is not claimed as confidential. To make this document available for public viewing, EPAwill remove only the information containedwithin the brackets.

Date

Date Jim Willis, Director Chemical Control Division Office ofPollution Prevention and Toxics

Name: Title: Processor Company:ATTACHMENT A DEFINITIONS [Note: The attached Order may notcontain some of the terms definedbelow.] "Chemical name" means the scientific designation ofa chemical substances inaccordance with the nomenclature system developed bythe International Union ofPure and Applied Chemistry orthe Chemical Abstracts Service's rules ofnomenclature, or a name which will clearly identifY a chemical substances for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items ofclothing that provide a protective barrier to prevent dermal contact with chemical substances ofconcern. Examples can include, but are not limited to: full bodyprotective clothing, boots, coveralls, gloves,jackets, andpants. "Company" means the person orpersons that submitted the PMNs that are the subject of the Company's Consent Order. "Commercial use" means the use ofa chemical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Common name" means any designation oridentification such as code name, code number, trade name, brand name, or generic chemical name usedto identifY a chemical substance other thanby its chemical name. "Consumer" means a private individual who uses a chemical substance or any product

, containing the chemical substance in or around a permanent or temporary household orresidence,

during recreation, orfor any personal use orenjoyment. "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 permanent ortemporary household orresidence, in or around a school, orin recreation. "Container"means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, orthe like that contains a hazardous chemical. For purposes ofthis section, pipes orpiping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers, "Contract Manufacturer" means a person, outside the Company, who is authorized to manufacture and import the PMN substance under the conditions specified in Part II, ofthis Consent Order and in the Consent Order for Contract Manufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containing that substance.2 "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is under the control of, and used only by, theperson who transferred it from a labeled container and will onlybe used bythatperson within the work shiftin which it is transferred from the labelled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical or mechanical degradation, permeation, or penetration ofthe chemical protective clothing under the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health ofthe V;S. Department ofHealth and Human Services. "Non-enclosedprocess" means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe 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 submitted bythe Companyrelevantto this Order. "Personal protective equipment" means any chemical protective clothing or device placed on the body to prevent contact with, and exposure to, an identified chemical substance or substances in the work area. Examples include, but are notlimited to, chemicalprotective 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" means the preparation ofa chemical substance or mixture, after its manufacture, for distribution in commerce (A)in the same form orphysical state as, or in a different form or physical state from, that in which it was received by the person so preparing such substance or mixture, or (B) as part ofan article containing the chemical substance or mixture. "Processor" means the person or persons subject to this Consent Order for Processor. "Process stream" means all reasonably anticipated transfer, flow, or disp'osal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of

### 3 processing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA-approved protocol orthe Good Laboratory Practice Standards at 40 CFRPart 792 without prior or subsequent Agency

. approval thatprevents a reasoned evaluation ofthe health or environmental effects ofthe PMN

substance. "Scientifically equivocal data" means data which, although developed in apparent conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk ofinjury to hnman health orthe environment ofthePMN substance. "Sealed container" means a closed container that is physically and chemically suitable for long-term containment ofthe PMN substance, and from which there will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, ordisposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, orconsumer use. "Waters ofthe United 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, orused and where employees are present. "Workplace" means an establishment at one geographic location containing one or more work areas.