UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OFNEW CHEMICAL SUBSTANCES PENDING DEVELOPMENT OF INFORMATION

In the matter of: ) ) ) ) ) 

### ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) ) PremanufactureNotice Numbers:

Nano-C, Inc. P-09-142-144

Consent Order, Consent Order for Processor, and Determinations Supporting Consent Orders

### TABLE OF CONTENTS

Preamble I. Introduction II. Summary ofTenns ofthe Order III. Contents ofPMN IV. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. Infonnation Required to Evaluate Human Health Effects Consent Order I. Scope ofApplicability and Exemptions II. Tenns ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInfonnation III. Recordkeeping IV. Requests for Pre-Inspection Infonnation 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 Processor

## PREAMBLE I. 

### INTRODUCTION Under the 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 ("PMNs") P-09-142-144 for the following chemical substances, 3'H-Cyclopropa[1,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No: 160848-22-6, P-09-142), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'- butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 1051371-21-1, P-09-144) (the "PMN substances") submittedbyNano-C, Inc. ("the Company"), to take effect upon expiration ofthe PMN review period. The Company submitted the PMNs to EPApursuant to section 5(a)(l) ofTSCA and 40 CFRPart 720.
Under § 15 ofTSCA, it is unlawful for any person to fail or refuse to comply with any provision of

### § 5 or any order issuedunder 

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

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



### II. SUMMARY OF TERMS OF THE ORDER The Consent Order for these PlviN substances requires the Companyto: (I) Submit to EPA certain health test data and physical/chemical property databefore exceeding

a specified manufacturing and import volume;(2) Provide workers with impervious gloves and clothing that covers any other exposed areas of the arms, legs, and torso; (3) Provide workers with a NIOSH-approved full-face respirator with anN -100 cartridge when exposed by inhalation inthe work area; (4) Use the PMN substances only as: (I) a compound used in fabrication and/or operation of electronic devices that enables or improves the conductivity, efficiency, voltage or other characteristics ofthe device; or (2) a compound used to improve the mechanical properties of lubricants and plastics; (5) Distribute the PMN substances onlyto a person who agrees to follow the same restrictions (exceptthe testing requirements); (6) Comply with the Release to Waterprovisions; and (7) Maintain certainrecords. 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 ithas carefully reviewed this document andhereby agrees that all information herein that is claimed as confidential by the Company (per section 14 ofTSCA, 40 CFRPart 720 Subpart E, and 40 CFR Part 2) is correctly identified within brackets and that any information that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within the brackets. Confidential Business Information Claims (Bracketed in the Preamble and Order): Impurities, production volume, byproducts, process description, environmental release anddisposal, and worker/occupational exposure. Chemical Identity: modified fullerene C60

- P09-0142, and modified fullerenes C70

- P09-143- 144; 3'H-Cyclopropa[1,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3 '-phenyl-, methyl ester (CAS No: 160848-22-6, P-09-142), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'- butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 1051371-21-1, P-09-144).

Use: (I) a compound used in fabrication and/or operation of electronic devices that enables or improves the conductivity, efficiency, voltage or other characteristics ofthe device; or (2)

a compound used to improve the mechanical properties oflubricants and plastics; Maximum 12-MonthProductionVolume: P-09-142 - [ ] kg/yr, P-09-143-144 - [ ] kg/yr. Test Data Submitted with PMN: Particle size distribution.


### IV. EPA'S ASSESSMENT OF RISK The following are EPA's predictions regarding the probable toxicity, human exposure and environmental release ofthe PMN substances, based on the information currently available to the Agency. Human Health Effects Summary: Absorption ofthe chemicals is expectedto be poor via all routes ofexposure based ontest data for chemicals with similar molecular structures and chemicals with similarphysical/chemicalproperties. Toxicological Endpoints ofConcern: There is concern for lung effects based onthe EPA Respirable, Poorly Soluble Particulates chemical category. See www.epa.gov/opptlnewchems/pubs/cat02.htm#Respirable. Based on analogy to otherrespirable, poorly soluble particles with diameter ofless than 10 microns, there is potential risk for adverse lung effects including cancer, lung fibrosis, lung inflammation and systemic effects, including immunotoxicity, ifinhaled. The PMN substances may induce gene mutation inbacterial cells and in manunalian cells in culture and 

### in vivo, chromosomal effects in mammalian cells in culture and 

### in vivo, and DNA effects in manunalian cells in culture and 

### in vivo. There is concern that the PMN substances may disperse/disaggregate inthe lung fluids to nanoscle particles. Hence, there is a concern for systemic effects ofnanoparticles beyondthe lungs, including adverse cardio-vascular effects. Based on published scientific data, some nanoparticles appear to have immunotoxicityhazard potential. Pulmonary exposure to these PMN substances may lead to toxicity to alveolar macrophage, impaired clearance ofinhaled bacteria and possible systemic immunosuppression. Occupational Exposure TABLE I - P09-142 Scenario # Sites # Workers Inhal (mg/d) Derm (mg/d) Manufacturing 

## [ 1 [1 0.64 (particle) 3100 (solid) Processing 

## [ 1 [ 1 0.0064 (particle) 3100 (solid) 18 (liquid) Use 

## [ 1 [1 negligible 87 (liquid)TABLE 2 - P09-l43/144 Scenario # Sites # Workers Inhal (mg/d) Derm(mg/d) Manufacturing 

## [1 [1 0.32 (particle) 3100 (solid) Processing 

## [ 1 [1 0.032 (particle) 3100 (solid) 18 (liquid) Use 

## [1 [1 negligible 87 (liquid) Risk to Workers: A comparison ofTables 1 and 2 above indicates a greater predicted inhalation exposure value (0.64 mg/day) during manufacturing for P09-l42. Therefore, since P09- 142/143/144 are close analogues, the inhalation exposure value of0.64 mg/day (0.064 mg/m3) and the NCEL (New Chemical Exposure Limit) of 0.05 mg/m3 for crystalline silica was used for EPA'srisk assessment calculations. Therefore, the predicted worst case worker inhalation exposure of0.064 mg/m3 for P09-l42 during manufacturing, when compared to the NCEL of 0.05 mg/m3 for crystalline silica, poses a potential carcinogenic risk to workers exposed via inhalation.
Risk to General Public: A qualitative evaluation ofestimatedreleases indicates a lowpotential risk to the general population from exposure to the PMN substances via water, landfill, and/or incinerationreleases.

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, pursuantto § 5(e)(1)(A)(i) ofTSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation ofthehumanhealth effects ofthe PMN substances.(b) In light ofthe potential risk to hnrnan health posedbythe uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substances, EPA has concluded, pursuantto § 5(e)(1)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal ofthePMN substances may present an unreasonable risk ofinjury to hnrnan health.

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS Triggered Testing. The Orderprohibits the Company from exceeding a specified production volnrne or time period unless the Company submits the information described in the Testing section ofthis Order in accordance with the conditions specified inthe Testing section.

## CONSENT ORDER SCOPE OF APPLICABILITYAND EXEMPTIONS (a) Scope. The requirements ofthis Order apply to all commercial manufacturing, processing, distribution in commerce, use and disposal ofthe following chemical substances, 3'HCyclopropa[l,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No: 160848-22-6, P-09-142), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'- butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 1051371-21-1, P-09-144) (the "PMN substances"), inthe United States by Nano-C, Inc. ("the Company"), exceptto the extentthat those activities are exemptedby paragraph (b). (b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substances are exempt from the requirements ofthis Order (exceptthe requirements inthe Recordkeeping and Successor Liability Upon Transfer OfConsent Order sections) only to the extentthat (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. (I) 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)2 incorporated or embedded into a polymermatrix that itselfhas been reacted (cured); (iii) embedded in apermanent solidpolymer form that is not intended to undergo further processing except for mechanical processing; or (iv) incorporated into an article as defined at 40 CFR 120.3(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 120.3(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" 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 inthe territory ofthe United States. Priorto leaving U.S. territory, even those quantities or batches ofthe PMN substances that are destined for export are subjectto terms ofthe Order, and count towards any production volume test triggers inthe Testing section ofthis Order. (3) Research & Development ("R&D''). The requirements of this Order do notapply 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 120.3(cc), and 40 CFR 120.36. (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 120.3(d) and in compliance with 40 CFR 120.30(g).3 (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 pursuant to any ofthe exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substances, mixture, or article ofwhich they are a part.

(c) Automatic Sunset. Ifthe Companyhas obtained for the PMN substances a Test Market Exemption ("TME") under TSCA §5(h)(l) and 40 CFR 720.38 or a LowVolume Exemption ("LVE") or Low Release and Exposure Exemption ("LoREx") under TSCA §5(h)(4) and 40 CFR 723 .s0(c)(1) and (2) respectively, any such exemption is automatically rendered null and void as ofthe effective date ofthis Consent Order.

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTIONIN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSIONAND EVALUATION OFINFORMATION

PROHIBITION The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe PMN substances inthe United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for a reasoned evaluation ofthe human health effects ofthe substances, and the completion ofEPA'sreview of, and regulatory action based on, that information, exceptin accordance with the conditions described inthis Order.4

TESTING (a) Section 8ee) Reporting. Any information onthe PMN substances which reasonably supports the conclusionthat the PMN substances present a substantial risk ofinjury to health orthe environmentrequired to be reported underEPA'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 identificationnumbers for these substances and shall contain a statementthat the substances are subject to this Consent Order. Additional information regarding section 8(e) reporting requirements canbe found inthe reporting guide referenced at 56 Federal Register 28458 (June 20,1991).

(b) Notice ofStudy Scheduling. The Company shall notify, in writing, the EPA Laboratory Data Integrity Branch (2225A), Office ofEnforcement and Compliance Assurance, U.S. Environmental Protection Agency, 1200 PennsylvaniaAvenue, N,W., Washington, D.C. 20460, ofthe following information within 10 days ofscheduling any study required to be performed pursuantto this Order, orwithin 15 days after the effective date ofthis Order, whichever is**later~** (1) The date when the study is scheduled to commence; (2) The name and address ofthe laboratory which wilI conduct the study; (3) The name and telephone number ofa person at the Company or the laboratory whom EPA may contactregarding the study; and (4) The appropriate PMN identification numbers for the substances and a statementthat the substances are subjectto this Consent Order.5 (c) Good Laboratory Practice Standards and Test Protocols. Each study required to be perfonned pursuantto this Ordermust be conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and using methodologies generally accepted inthe relevant scientific community at the time the study is initiated. Before startingto conduct any such study, the Company must obtain approval oftestprotocols, including selection ofthe test substances, from EPA by submitting writtenprotocols. EPA will respond to the Company within 4 weeks ofreceiving the written protocols. Publishedtest guidelines specified inparagraph (d) provide general guidance for development oftestprotocols, butare notthemselves acceptable protocols. Approval ofthe test protocol does not meanpre-acceptance oftestresults.

(d) Triggered Testing Requirements. (1) 90-day inhalation toxicity test. The Company is prohibited from manufacturing or importingthe PMN substances beyondthe following aggregate manufacture and importvolume ofall three PMN substances combined ("the production limit"), unless the Company conducts the following test on one ofthe PMN substances (selected bythe Company and approved by EPA) and submits all final reports and underlying data in accordance with the conditions specified in this Testing section. Production Limit 

## [ 1 kg Test Guideline 90-day inhalation toxicity study onrats with a post-exposure OCSPP 870.3465 observationperiod ofup to 3 months, or OECD 413 including bronchoalveolar lavage fluid ("BALF") analysis, a detennination ofcardiovasculartoxicity (clinically-based blood/plasmaprotein analyses), and histopathology of the heart along with data onpulmonary deposition,6 clearance half-life (biopersistence) and translocation ofthe test material and particle size distributions prior to, and during, the inhalationtests. Physical/chemical properties. The Company is prohibited from manufacturing or importing, or causing another person to manufacture or import, any ofthe PMN substances beyond 9 months after the first date ofcommencement ofnonexempt commercial manufacture or import ofanyone ofthe PMN substances ("the production limit"), unless the Company provides the following data for each ofthe PMN substances and submits all final reports and underlying data in accordance with the conditions specified in this Testing section:

Water solubility (OECD 105 test method); Surface chemistry: EELS (electron energy loss spectroscopy) and/or XPS (ESCA) (X-ray photoelectron spectroscopy/electron spectroscopy for chemical analysis), functionalized probe AFM (atomic force microscopy), or Auger electron spectroscopy; Dry particle size distributionby count for each PMN substance in a form which has the highest content ofparticles smallerthan 10 microns as manufactured, processed orused inthe workplace at sites controlled by the Company. The method shall be STEM (scanning transmission electron microscopy), using a dry particle counting method, with a resolution of< I nanometer and with no counting after dispersion in a solution and evaporating solvent); and

- Dustiness test (EN 15051 method) Description ofthephysical-chemical properties ofthe material tested shouldtake into consideration the characterizations identified in the mostrecent version ofthe Guidance Manual for the Testing ofManufactured Nanomaterials: OECD's Sponsorship Programme. (e) Test Reports. The Company shall: (I) conduct each study in good faith, with due care, and in a scientifically valid manner; (2) promptly furnish to EPA the results ofany interim phase of each study; and (3) submit, intriplicate (with an additional sanitized copy, ifconfidential7 business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA no later than 14 weeks priorto 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", "Data and Reporting", and "Test Report" subparagraphs inthe applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to make clearthatthe submission ofsuch information is mandatory. EPA will notrequire the submission ofrawdata such as slides and laboratory notebooks unless ifEPA finds, on the basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannot take place inthe absence ofthese items.

(f) Testing Waivers. The Company is notrequired to conduct a study specified inparagraph (d) ofthis Testing section ifnotified in writing by EPA that it is unnecessary to conduct that study.

(g) Equivocal Data. IfEPA finds thatthe data generated by a study are scientifically equivocal, the Company may continue to manufacture and importthe PMN substances beyondthe applicable production limit. To seek relieffrom any otherrestrictions ofthis Order, the Company may make a second attemptto obtain unequivocal data byreconducting the study underthe conditions specified in paragraphs (b), (c), and (e)(1) and (2). The testing requirements may be modified, as necessary to permit a reasoned evaluation ofthe risks presented bythe PMN substallces, only by mutual consent ofEPA and t.he Company.

(h) EPA Determination ofInvalid Data.

### 8 (I) Except as described in subparagraph (h)(2), if, within 6 weeks ofEPA's receipt ofa testreport and data, the Company receives written notice thatEPA finds that the data generated by

a study are scientifically invalid, the Company is prohibitedfrom further manufacture and import ofthe PMN substances beyond the applicable production limit. (2) The Company may continue to manufacture and importthe PMN substances beyond the applicable production limit only ifso notified, in writing, by EPA inresponse to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Company mayreconduct the study in compliance withparagraphs (b), (c), and (e)(1) and (2). Ifthere is sufficient time 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 in triplicate to EPA within a reasonable period oftime, all as specified by EPA in the notice described in subparagraph (h)(I). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data. (ii) The Company may, within 4 weeks ofreceiving from EPA the notice described in subparagraph (h)(l), submitto EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company'sreport.

(i) Company Determination ofInvalidData. (1)Except as described in subparagraph (i)(2), ifthe Company becomes aware that circumstances clearly beyond the control ofthe Company or laboratory will prevent, orhave prevented, development ofscientifically valid data under the conditions specified inparagraphs (c)9 and (e), the Company remains prohibited from further manufacture and import ofthe PMN substances beyond the applicable production limit. (2) The Company may submitto EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearlybeyondthe control ofthe Company or laboratory will cause or have caused development ofscientifically invalid data. EPA will notify the Company ofits response, in writing, within 4 weeks ofreceivingthe Company's report. EPA's written response may either: (i) allowthe Company to continue to manufacture and importthe PMN substances beyondthe applicable production limit, or (ii) require the Company to continue to conduct, orto reconduct, the study in compliance withparagraphs (b), (c), and (e)(1) and (2). Ifthere is sufficienttime to conduct or reconductthe study and submitthe report and datato EPA at least 14 weeks before exceedingthe production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficienttime for the Company to comply with subparagraph (e)(3), the Company may exceed the production limit and shall submitthe report and datain 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, inwriting, within 6 weeks ofreceiving the Company's report and data, as to whetherthe Company may continue to manufacture and import beyondthe applicable production limit. 

## G) Unreasonable Risk. (1) EPA may notify the Company in writing that EPA finds thatthe data generatedby a study are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the10 PMN substances will or may present an unreasonable risk ofinjury to human health or the environment. EPA's notice may specify that the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substances to mitigate exposures to orto better characterize the risks presented by the PMN substances. Within 2 weeks from receipt ofsuch 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 0)(1), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks from receipt ofthe notice described in subparagraph (j)(1), the Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of any additional requirements imposed by EPA. The Company may continue to manufacture, import, process, distribute, use and dispose ofthe PMN substances in accordance with the terms of this Order pending EPA'sresponse to the Company's writtenreport. EPA willrespondto the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks of receipt ofEPA's writtenresponse, the Company shaH comply with any requirements imposed by EPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substances.

(k) OtherReguirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continue to obey all the terms ofthis Consent Orderuntilotherwise notified in writing byEPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modify or revoke provisions ofthis Consent Order pursuantto Part11 VI ofthis Consent Order.

PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. During manufacturing, processing, and use ofthe PMN substances at any site controlled bythe Company (including any associated packaging and storage and during any cleaning or maintenance ofequipment associated withthe PMN substances), the Company must establish a program whereby: (1) General Dermal Protection. Eachpersonwho is reasonably likely to be dermally exposed inthe work area to the PMN substancesthrough direct handling ofthe substances or through contact with equipment on whichthe substances may exist, or because the substances become airborne in a form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, personal protective equipmentthatprovides a barrierto prevent dermal 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 protection requirements at 29 CFR 1910.132,1910.133, and 1910.138. (2) Specific Dermal Protective Equipment. The dermal personal protective equipment required by subparagraph (a)(I) ofthis section must include, but is 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 Company is able to demonstrate that each item ofchemical protective clothing selected, including gloves, provides an impervious barrier to prevent dermal exposure during normal and expected duration and conditions ofexposure within12 the work areaby anyone or a combination ofthe following: (i) Permeation Testing. Testing the material used to make the chemical protective clothing and the construction ofthe clothing to establishthat the protective clothing will be impervious for the expected duration and conditions ofexposure. The testing must subjectthe chemical protective clothing to the expected conditions ofexposure, including the likely combinations ofchemical substances to whichthe clothing may be exposed inthe work area. Permeation testing shall be conducted according to the American Society for Testing and Materials ("ASTM") F739 "Standard Test Method for Resistance ofProtective Clothing materials to Permeation 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 specifiedin ASTM F1194-89 "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 be replaced at the end ofeach work shift during which they are exposedto 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 establishthat the chemical protective clothing will be impervious to the PMN substances alone and in likely combination with other chemical substances in the work

area. (4) Respiratory Protection. Each person who is reasonably likely to be exposed by inImlation in the work area to**t.~e** PMN Substa.l1ces 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 in accordance13 with the Occupational Safety and Health Administration ("OSHA") and NIOSH respiratory protection requirements at 29 CFR 1910.134 and 42 CFR Part 84. All respirators must be issued, used, and maintained according to an appropriate respiratory protection programunder 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 minimum requirements for subparagraph (a)(4) ofthis section: NIOSH-certified airpurifying, tight-fitting full-face respirator equipped with N100 cartridges.

MANUFACTURING (a)(l) Prohibition. The Company shall not cause, encourage, or suggest the manufacture or import ofthe PMN substances by any otherperson. (2) SunsetFollowing SNVR. Subparagraph (a)(I) shall expire 75 days after promulgation ofa final significant newuse 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 SNUR. Ifthe Company is so notified, subparagraph (a)(l) shall not expire until EPA notifies the Company inwriting that all Federal Court actions involving the SNURhave 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 or import the PMN substances of

### 14 the existence ofthe SNUR.

(b) Prohibited Uses. The Company shall notmanufacture or importthe PMN substances for

use other than as: (1) a compound used in fabrication and/or operation ofelectronic devices that enables or improves the conductivity, efficiency, voltage or other characteristics ofthe device;

or (2) a compound used to improve the mechanical properties oflubricants and plastics. The Company shall not mix ormanufacture the PMN substance to encapsulate another chemical substance.
PROCESSING AND USE The Company shall notprocess or use the 

### PMN substances otherthan as: (1) a compound used in fabrication and/or operation of electronic devices that enables or improves the conductivity, efficiency, voltage or other characteristics ofthe device; or (2) a compound used to improve the mechanical properties oflubricants and plastics. The Company shall notmix, process oruse the PMN substances to encapsulate another chemical substance.

DISTRIBUTION (a) Export Notice Requirement. No laterthanthe date ofdistribution, the Company shall notifY in writing any personto whom it distributes the PMN substances (aDistributee) that, due to the issuance ofthis Consent Orderunder section 5(e) ofTSCA, the PMN substances are subjectto the exportnotificationrequirements ofTSCA section 12(b) and 40 CFRPart 707 Subpart D. Such notice shall contain, in the form in whichthey appear inthe Consent Order, the following information: (1) the PMN numbers and (2) either (A) the specific chemical identities ofthe15 chemical substances, or (B) ifthe specific chemical identities are confidential, the generic chemical identities.

(b) Types ofDistributees. This Distribution section authorizes the Company to distribute the PMN substances to three types ofDistributees: (1) Distributees who will further distribute the PMN substances only whenthe PMN substances are in a mitigated state, as defined in paragraph (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 governing all ofthe PMN substances; and (3) Distributees who will further distribute the PMN substances in an unmitigated state after the attached Consent Order for Processorexpires 75 days afterpromulgation ofa final SNUR governing all ofthe PMN substances. The distribution requirements for the first andthird type ofDistributee are identical and are stated inparagraph (e) below. The secondtype ofDistributee must sign the attached Consent Order for Processor, as specified inparagraph (f) below.

(c) Mitigated States ofthe PMN Substances. Forpurposes offurther distribution, the PMN substances shall be considered to be in a "mitigated state" (regarding risk) whenthe PMN substances have been (i) completely reacted (cured); (ii) incorporated or embedded into 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 mechanicalprocessing; or (iv) incorporated into an article as defined at 40 CFR nO.3(c).16 (d) Temporary Transport and Storage. Notwithstandingparagraphs (e) and (t) inthis Distribution section, the Company may distribute the PMN substances outside the Company for temporary transport and storage in sealed containers provided the following two conditions are met: (l) Subsequentto 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 (e) or (t). (2) Any human exposure orenvironmental release resulting from opening the sealed containers and removing or washing outthe 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 in the Absence ofProcessor Order. Exceptwhenthe PMN substances are in a mitigated state as described inparagraph (c) above, or as provided inthe 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 substance outside the Company, otherthan for disposal, only to a Distributee who has agreed in writing prior to the date ofdistribution, to: (1) Notify in writing any personto whom it distributes the PMN substance that, due to the issuance ofthis Consent Orderunder section See) ofTSCA, the PMN substance is subject to the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, inthe form in which it appears inthis Consent Order, the following information: (l) the PMN number, and (2) either (A) the specific chemical identity ofthePMN17 substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Not further 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 (c) above. (3) Comply with the same requirements and restrictions required ofthe Company in the Protection inthe 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 other than as: (l) a compound used in fabrication and/or operation of electronic devices that enables or improves the conductivity, efficiency, voltageorother characteristics ofthe device; or (2) a compound used to improve the mechanical properties oflubricants and plastics; (6) Not mix, process, or use the PMN substance to encapsulate another chemical substance.

(f) 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 Order for 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, onlyto a Distributee who has signed the Consent Order for Processor in Attachment 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 with the name, address, and telephone18 number ofa responsible official ofthe Processor. The Processor or Company mustreceive 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 anunmitigated 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, onlyto processors who have signed the attached Consent Order for Processor in accordance with paragraph (f) ofthis Distribution section. Afterthe attached Consent Order for Processor expires 75 days after promulgation ofa fmal SNUR governing all ofthe PMN substances, the Company shall distribute the PMN substances onlyto Distributees who comply withthe requirements specified in paragraph (e) ofthis Distribution section. (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 or before 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 inwriting that all Federal Court actions involving the SNURhave beenresolved andthe validity ofthe SNUR affirmed. (3) When EPApromulgates 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 ofthe19 SNUR. Suchnotificationmust be in writing and must specifically include all limitations contained inthe SNURwhich are defined as significant newuses, and whichwould 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. Afterpromulgation ofa SNUR and expirationofparagraphs (e)(2) and (f), such notice may substitute for the written agreement required inthe introductory clause ofparagraph (f); so that, ifthe Company provides suchnotice to the Distributee, thenthe Company is not required to obtain from such Distributee the written agreement specified in paragraph (e). However, even absent suchwritten agreement, the Company remains 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 comply with any ofthe applicable conditions specified in paragraphs (e)(2) or (f) ofthis Distribution section or, after paragraphs (e)(2) or (f) expires in accordance with paragraph (g)(2), has engaged in a significant newuse ofthe PMN substances (as defined in 40 CFR Part 721, Subpart E) without submitting a significant newuse notice to EPA, the Company shall cease supplying the substances to thatrecipient, unless the Company is able to document each ofthe following: (1) Thatthe Company has, within 5 working days, notified the recipient inwritingthatthe recipient has failed to comply with any ofthe applicable conditions specified in paragraphs (e)(2)

or (f) ofthis Distribution section, or has engaged in a significantnewuse ofthe PMN substances without submitting a significant newuse notice to EPA.

### 20 (2) That, within 15 working days ofnotifying the recipient ofthenoncompliance, the Company received from the recipient, in writing, a statement ofassurance that the recipient is

aware ofthe applicable terms ofparagraphs (e)(2) or (f) ofthis Distribution section and will comply with those terms, or is aware ofthe terms ofthe significant newuse rule for the PMN substances and will not engage in a significant newuse without submitting a significant newuse 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 specified in paragraphs (e)(2) or (f) ofthisDistribution section, or has engaged in a significantnewuse ofthe PMN substances without submitting a significant newuse 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.



### RELEASE TO WATER This provision does not supercede or preempt any applicable federal, state, or local laws and regulations. Those may be more stringent than the requirements below. The Company is prohibited from any predictable or purposeful release ofthe PMN substance, or any waste stream from manufacturing, processing or use containing the PMN substance into the waters ofthe United States.



### III. RECORDKEEPING (a) Records. The Company shall maintain the following records until 5 years after the date they21

are created and shall make them available for inspection and copying by EPA in accordance with section II ofTSCA: (1) Exemptions. Records docnmenting thatthe PMN substances did in fact qualify for any

one or more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemption being claimed by the Company. 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 Company maintains, for 5 years from the date oftheir creation, copies ofthe export label and exportnotice to EPA, required by TSCA 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 inthis Recordkeeping section, ifthe Companymaintains, 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 described in Section I, Paragraph (b) ofthis Order, the Company shall keep records demonstrating qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, but is exempt from the other recordkeeping requirements inthis Recordkeeping section; (2) Records documenting the manufacture and importationvolnme ofthe PMN substances andthe corresponding dates ofmanufacture and import; (3) Records docnmenting the names and addresses (including shipment destination 

### address, 

### ifdifferent) ofall persons outside the site ofmanufacture or import to whom the Company directly sells or transfers the PMN substances, the date ofeach 

### sale or transfer, and the quantity of the substances sold ortransferred on such date;22 (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 equipment required pursuantto the Protection in the Workplace section ofthis Order; (6) Records documenting the determinations required by the Protection inthe Workplace section ofthis Orderthat 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 of this Order, including any Consent Order for Processors and distributees' written agreement to comply with the Distribution section ofthis Order; (8) Records documenting compliance with the Release to Waterprovisions; (9) Copies ofany Transfer Documents and notices required by the Successor Liability section ofthis Order, ifapplicable; and (10) The Company shall keep a copy ofthis Order at each ofits sites where the 

### PMN substances are manufactured ofimported.

(b) Applicability. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Company and not to activities ofthe Company's customers.

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 1320, particularly 5 CFR 1320.5(b), the Company is notrequired to respond to this "collection ofinformation" unless this Order displays a currently valid control number from the

### 23 Office ofManagement and Budget ("OMB"), and EPA so informs the Company. The "collection ofinformation" required inthis TSCA §5(e) Consent Orders has been approved under currently valid OMB Control Number 2070-0012.

IV. REOUESTS 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, EPApersonnel may contact the Company in advance to request information pertinentto the scheduling and conduct ofsuch inspections. Suchrequests maybe written or oral. The types ofinformation that EPA may request may include, but are not limited to, the following: (i) Expected dates and times whenthe PMN substances will be in production within the subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with 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 exposedto the PMN substances; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substances and may reasonably be exposedto the PMN substances; (v) Records required by the Recordkeeping section ofthis Order; and/or (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for thatpurpose.24 (b) Company's Response. The Company shall respond to such requests within a reasonable period oftime, but in no event later than 30 days after receiving EPA's request. When requested in writing by EPA, the Company's response shall be in writing. To the extentthe information is known to orreasonably ascertainable to the Company at the time ofthe request, the Company's response shall demonstrate a good faith effortto provide reasonably accurate and detailed answers to all ofEPA'srequests.

(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the Company submits to EPA pursuantto paragraph (b) shall be protected in accordance with 

### §14 of TSCA and 40 CFRPart 2.

V. SUCCESSORLIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by which the Company'srights and obligations under this Order may be transferred when the Company transfers its interests inthe 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) BeforeNOC. Ifthe transfer from the Company to the Successor in Interest is effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN substances from the Companypursuantto 40 CFR 720.102, the Successor in Interest must submit

new PMNs to EPA and comply fully with Section 5(a)(l) ofTSCA and 40 CFRpart 720 before commencing manufacture or import ofthe PMN substances.

### 25 (2) After NOC. 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 tenns ofthis Order and shall not

### be required to submitnewPMNs to EPA.

(c) Definitions. The following definitions apply to this Successor Liability sectionofthe Order: (I) "Successor in Interest" means a person outside the Companywho has acquired the Company's full interest inthe rights to manufacture the PMN substances, including all ownership rights and legal liabilities, through a transfer document signed bythe Company, as transferor, and the Successor in Interest, as transferee. The tenn excludes persons who acquire less thanthe full interest ofthe Company inthe PMN substances, such as a licensee who has acquired a limited license to thepatent ormanufacturing rights associated with the PMN substances. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 

### 40 CFR n0.22(a)(3). (2) "TransferDocument" means the legal instrument(s) used to convey the interests inthe PMN substances, includingthe rightto manufacturethe PMN substances, from the Companyto the Successor in Interest.

(d) Notices. (1) Notice to Successor in Interest. On orbefore the effective date ofthe transfer, the Company shall provide to the Successor in Interest, by registered mail, a copy ofthe Consent Order a.'1d the "Notice ofTransfer" document which is incorporatedbyreference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days ofthe effective date ofthe transfer, the26 Company shall, by registered mail, submitthe fully executed Notice ofTransfer document to: U.S. Environmental Protection Agency, New Chemicals Branch (7405),1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies ofthe TransferDocumentmust be maintainedby the Successor in Interest atits 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 pursuant to 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.

(e) Liability. (l) The Company shall be liable for compliance with the requirements ofthis Order until the effective date ofthetransfer 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 prohibit the Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, or omissions made, during the time in which the Company manufactured, processed, used, distributed in commerce, or disposed ofthe PMN substances pursuantto the terms ofthis Consent Order.

(f) Obligations to '<ubmit Test Dataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Order requires the Companyto submittest datato EPA at a specified production volume ("testtrigger"), the aggregate volume ofthe PMN substances manufactured and imported27 bythe Company upto the date oftransfer shall counttowards thetest trigger applicable to the Successor in Interest.

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company may petitionEPA at any time, basedupon newinformation onthe health effects of, or human exposure to, the PMN substances, to modify orrevoke substantive provisions ofthis Order. 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 inthe preamble to this Order. However, in determining whetherto amend or revoke 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 orrevocation ifEPA determines that the activities proposed therein will not present anunreasonable risk ofinjury to health or the environment and will not result in significant or substantial human exposure or substantial environmental release inthe absence ofdata sufficient to permit a reasoned evaluation ofthehealth or environmental effects of the PMN substances. In addition, the Company may petition EPA at any time to make other modifications to the language ofthis Order. EPA will issue such a modificationifEPA determines that the modification is useful, appropriate, and consistent withthe structure and intent ofthis Order as issued.

### 28 VII. EFFECT OF CONSENT ORDER (a) Waiver. Byconsentingto the entryofthis Order, the Companywaivesits rights to file objections to this Orderpursuantto section 5(e)(l

### )(C) ofTSCA, to receive service ofthis Orderno laterthan45 days beforethe end ofthereviewperiodpursuant to section 5(e)(I)(B) ofTSCA, and to challengethe validity ofthis Orderin any subsequent action. Consentingto the entryofthis Order, and agreeing to beboundbyitsterms, do not constitute an admissionbythe Companyas to, the facts or conclusions underlyingtheAgency's determinations inthisproceeding.

0This waiver does not affect anyotherrights thatthe Companymayhaveunder TSCA. (b) 

## cm Brackets. Bysigning this Order, the Companyrepresents that ithas carefullyreviewed

othis document andhereby agrees that all informationherein that is claimed as confidentialbythe Company (per section 14 ofTSCA, 40 CFRPart720 SubpartE, and40 CFRPart2) is correctly identifiedwithinbrackets and that anyinformationthatisnotbracketed isnotclaimed as confidential. To makethis documeiJ.t available forpublicviewing, EPAwillremove onlythe information contained within thebrackets.

# lof/~

# Lo Date 

# or I

Date Name: ViktorVejl s Title: President Company:Nano-C, lnc.ATTACHMENT A DEFINITIONS [Note: The attached Order may notcontain some a/the terms defined below.] "Chemical name" means the scientific designation ofa chemical substances in accordance with the nomenclature system developed bythe Chemical Abstracts Service's rules of nomenclature, or a name which will clearly identify a chemical substances for the purpose of conducting a hazard evaluation. "Chemical protective clothing" means items ofclothing thatprovide a protective barrierto prevent dermal contact with chemical substances ofconcern. Examples can include, but are not limitedto: full bodyprotective clothing, boots, coveralls, gloves,jackets, and pants. "Company" means the person or persons subject to this Order. "Commercial use" means the use ofa chemical substance or any mixture containing the chemical substance in a commercial enterprise providing saleable goods or a service to consumers (e.g., a commercial dry cleaning establishment orpainting contractor). "Commonname" 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 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 or residence, during recreation, or for any personal use or enjoyment. "Consumer product" means a chemical substance that is directly, or as part ofa mixture, sold or made available to consumers for their use in or around a permanent ortemporary household orresidence, in or around a school, or in recreation. "Container" means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage tank, or the like that contains a hazardous chemical. For purposes ofthis section, pipes or piping 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 inthe Consent Orderfor ContractManufacturer. "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 "immediate use" 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 bythatperson within the work shift in which it is transferred from the labeled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical or mechanical degradation, permeation, orpenetration ofthe chemical protective clothing under the conditions of, and the duration of, exposure. "Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations ofmanufacture, including the cleaning ofequipment. "MSDS" means material safety data sheet, the written listing ofdata for the chemical substance. "NIOSH" means the National Institute for Occupational Safety and Health ofthe U.S. Department ofHealth and Human Services. "Non-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 contact ofthebulk chemical substance and the workplace air may occur. "Non-industrial use" meansuse other than at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described inthe Premanufacture notice submitted by the Company relevant to 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 inthe work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types ofrespirators. Barrier creams are not included inthis definition. "Process" means the preparation ofa chemical substance ormixture, 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 ormixture. "Processor" means the person or persons subjectto the Consent Order for Processor in Attachment C. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of3 processing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA-approvedprotocol or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequentAgency approval thatprevents a reasoned evaluation ofthe health or environmental effects ofthe PMN substance. "Scientifically equivocal data" means data which, although developed in apparent conformity withthe Good Laboratory Practice Standards and EPA-approvedprotocols, are inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of the potential risk ofinjury to human health orthe environment ofthe PMN substance. "Sealed container" means a closed containerthat 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, 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 forth in 40 CFR 122.2. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one or more work areas.Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION See) CONSENT ORDER

PMNNumber I. Transfer ofManufacture Rights. Effective on ,the Company did sell or otherwise transfer to , ("Successor in Interest") the rights and liabilities associated with manufacture ofthe above-referenced chemical substances, which was the subject ofa premanufacture notice ("PMN") and is governed by a Consent Order issued by the U.S. Environmental Protection Agency ("EPA") under the authority of§5(e) oftheToxic Substances Control Act (TSCA, 15 U.S.C. §2604(e)). 2. Assumption ofLiability. The Successor in Interesthereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed bythe applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substances, shall be the responsibility ofthe Successor in Interest. Successor in Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with40 CFR nO.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, pursuant to Section 14 ofTSCA and 40 CFRpart 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is indicated, such modification shall be explained in detail in an attachment to this Notice of Transfer. Information which has been previously disclosed to the public (e.g., a chemical identity that was not claimed as CBI by the original submitter) would not subsequently be eligible for confidential treatmentunder 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

Successor in Interest

Signature ofAuthorized Official Date

Printed Name ofAuthorized Official
Title ofAuthorized Official

Address City, State, Zip Code3

TOXIC SUBSTANCES CONTROLACT

SECTION 5(e) 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 OFNEW CHEMICAL SUBSTANCES PENDING DEVELOPMENT OF INFORMATION
Inthe matter of: ) ) ) ) ) ) ) ) ) ) ) ) ) ) 

### ) ) ) ) ) ) ) ) ) ) ) ) PremanufactureNotice Numbers:

P-09-142-144

Consent Order for Processor11 

### TABLE OF CONTENTS Consent Order 1. 

### Scope ofApplicability and Exemptions II. Tertns ofManufactnre, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation III. Recordkeeping IV. Requests for Pre-Inspection Information V. Modification and Revocation ofConsent Order VI. Effect ofConsent Order Attachment A - Definitions

## CONSENT ORDER I. SCOPE, EXEMPTIONS AND TERMINATION (a) Scope. The requirements ofthis Order apply to all commercial processing, distribution in commerce, use and disposal, in the United States, ofthe following chemical substances, 3'H-Cyclopropa[I,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No: 160848-22-6, P-09-142), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'- butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 1051371-21-1, P-09-144) (the "PMN substances") submitted byNano-C, Inc. ("the Company"), and processed by

______ - ("the Processor"), exceptto the extent that those activities are exempted by paragraph (b). This Order is an attachment to a related Order applying to the Company, which among other requirements, prohibits the Company from distributing the PMN substances, unless they have been (i) completely reacted (cured); (ii) incorporated or embedded into 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 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 of2 the Company inthe Company's Consent Order.

(b) Sunset Following SNUR. The Consent Order for Processor (exceptthe 5-year recordkeeping requirements in Section III ofthis Order) shall expire 75 days after promulgationofa final significant new use rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA, unless the Processor is notified on or before that day ofan action in a Federal Court seeking judicialreview 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 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) onlyto the extentthat (1) these activities areconducted in full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documentedby 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 thathave been (i) completely reacted (cured); (ii) incorporated

or embedded into a polymer matrix that itselfhas beenreacted (cured); (iii) embedded in a permanent solid polymer form that is not intendedto undergo further processing except for mechanical processing; or (iv) incorporated into an article as defined at 40 CFR 720.3(c). (2) EXDort. Until the Processorbegins commercial processing 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 TSCA3 

### §l2(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Processorbegins to process the PMN substances for use in the United States, no further activities by the Processor involvingthe PMN substances are exempt as "solely for export" even ifsome amounts ofthe PMN substances are later exported. Atthatpoint, the requirements ofthis Order apply to all activities associated withthe PMN substances while in the territory ofthe United States. Priorto leaving U.S. territory, even those quantities or batches ofthe PMN substances that are destined for export

are subjectto terms ofthe Order, and count towards any production volume test triggers inthe 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 solelyfor research and development in accordance with TSCA §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 at40 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 whenthey are manufactured, processed, distributed in commerce, used andlor disposed pursuantto any ofthe exemptions in40 CFR 720JO(h), with no commercial purpose separate from the substances, mixture, or article ofwhichthey are a part.4 II. TERMS OF MANUFACTURE, IMPORT, PROCESSING,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION
PROHIBITION 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 fora reasoned evaluation ofthe human health effects ofthe substances, and the completion ofEPA'sreview of, and regulatory actionbased on, that information, except in accordance with the conditions described in this Order. TESTING (a) Section 8ee) Reporting. Reports ofinformation onthe PMN substances which reasonably supports the conclusionthat the PMN substances present a substantial risk ofinjury to health or the environment and which is required to be reported under TSCA section 8(e) shall reference the appropriate PMN identification numbers for these substances and shall contain a statement that the substances are subjectto this Consent Order. Additional informationregarding section 8(e) reporting requirements can be found atwww.epagov/opptltsca8e.

PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. Duringprocessing and use ofthePMN substances at any site controlledby 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:5 (1) General Dermal Protection. Eachperson who is reasonably likely to be dermally exposed in the work area to the PMN substances through direct handling ofthe substances or through contactwith equipment onwhich the substances may exist, or because the substances become airborne in a form listed in subparagraph (a)(5) ofthis section, is providedwith, and is required to wear, personal protective equipmentthatprovides a barrierto prevent dermal exposure to the substances in the specific work area where the substances are selected for use. Each such item ofpersonal protective equipment mustbe selected and used in accordance with OSHA dermal protection requirements at 29 CFR 1910.132, 1910.133, and 1910.138. (2) Specific Dermal Protective Equipment. The dermal personal protective equipment required by subparagraph (a)(l) ofthis sectionmust include, but is 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 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 of the following: (i) Permeation Testing. Testing the material used to make the chemical protective clothing and the construction ofthe clothing to establishthat the protective clothing will be impervious for the expected duration and conditions ofexposure. The testing must subjectthe chemical protective clothingto the expected conditions ofexposure, includingthe likely combinations ofchemical substances to whichthe clothing may be exposed in the work area. Permeation testing shall be conducted according to the American Society for Testing and Materials6 ("ASTM") F739 "Standard Test Method for Resistance ofProtective Clothing materials to Permeationby 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 inASTM F1194-89 "Guide for Documentingthe Results ofChemical Permeation Testing on Protective Clothing Materials." Gloves may notbe used for a timeperiod longer than they are actually tested andmust bereplaced at the end ofeach work shift during whichthey 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 establishthat the chemical protective clothing will be impervious to the PMN substances alone and in likely combination with other chemical substances in the work

area. (4) Respiratorv Protection. Eachperson who is reasonably likelyto be exposedby inhalation inthe work areato the PMN substances inthe 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 in accordance with the Occupational Safety and Health Administration ("OSHA") and NIOSH respiratory protection requirements 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).7 (6) Authorized Respirators. The following NIOSH-certified respirators meet the minimum requirements for subparagraph (a)(4) ofthis section: NIOSH-certified airpurifying, tight-fitting full-face respirator equipped with NlOO cartridges.

MANUFACTURING (a)(I) Prohibition. The Processor shall not manufacture the PMN substances, or cause, encourage,
or suggest the manufacture or import, ofthe PMN substances by any person other than the Company.

PROCESSING AND USE The Processor shall not process or use the PMN substances other than as (1) a compound used in fabrication and/or operation ofelectronic devices that enables or improves the conductivity, efficiency, voltage or other characteristics ofthe device; or (2) a compound used to improve the mechanical properties oflubricants and plastics. The Processor shall not mix, process or use the PMN substances to encapsulate another chemical substance.

DISTRIBUTION (a) ExportNotice Requirement. No later than the date ofdistribution, the Processor shall notify in writing any person to whom it distributes the PMN substances that, due to the issuance ofthis Consent Orderunder section 5(e) ofTSCA, the PMN substances are subject to the export notification requirements ofTSCA section 12(b) and 40 CPR Part 707 Subpart D. Such notice shall contain, in the form in which they appear in the Consent Order, the following information: (I) the PMN numbers and (2) either (A) the specific chemical identities ofthe chemical8 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" (regardingrisk) when the PMN substances have been (i) completely reacted (cured); (ii) incorporated or embedded into a polymer matrix that itselfhas beenreacted (cured); (iii) embedded in a permanent solidpolymerform 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).

(c) Temporary Transport and Storage. Notwithstanding paragraph (d) in this Distribution section, the Processor may distribute the PMN substances outside the Processor for temporary transport and storage in sealed containers provided the following two conditions are met: (I) 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 (d). (2) Any human exposure or environmental release resulting from opening the sealed containers and removing orwashing 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 (d).

(d) Distribution Requirements. Except whenthe PMN substances are in a mitigated state as described inparagraph (b) above, or as provided in the Temporary Transport and Storage9 paragraph (c) above, the Processor shall distribute the PMN substances outside the Processor's company, otherthan for disposal, only to the Company or a person ("Distributee") who has agreed in writing priorto the date ofdistribution, to: (1) 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 subjectto the export notificationrequirements ofTSCA section 12(b) and 40 CFRPart 707 Subpart D. Such notice shall contain, inthe form in which it appears in this Consent Order, the following information: (1) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Not further distribute the PMN substances to any other person, otherthan for disposal, exceptwhen the PMN substances are in a mitigated state, as described inparagraph (b) above. (3) Comply with the samerequirements and restrictions required ofthe Processorinthe

(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: (1) a compound used in fabrication and/or operation of electronic devices that enables or improves the conductivity, efficiency, voltage or other characteristics ofthe device; or (2) a compoundusedto improve the mechanical properties oflubricants and plastics; (6) Not mix, process, or use the PMN substance to encapsulate another chemical substance.

(e) RecipientNon-Compliance. If, at anytime after commencing distribution in commerce ofthe PMN substances, the Processor obtains knowledge that a recipient ofthe substances have failed to10 comply with any ofthe conditions specified inparagraph (d) ofthis Distribution section, the Processor shall cease supplyingthe substances to that recipient, unless the Processor is able to document each ofthe following: (1) Thatthe Processorhas, within 5 working days, notified the recipient in writing that the recipient has failed to comply with any ofthe conditions specified in paragraph (d) ofthis Distribution section, orhas engaged in a significant newuse ofthe PMN substances without submitting a significant new use notice to EPA. (2) That, within 15 working days ofnotifyingthe 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 ofthe terms ofthe significantnewuse rule for the PMN substances and will not engage in a significant new use without submitting a significant newuse notice to EPA. (3) If, after receiving a statement ofassurance from a recipient under subparagraph (e)(2) ofthis Distribution section, the Processor obtains knowledge thatthe recipienthas failed to comply with any ofthe conditions specified in paragraph (d) ofthis Distribution section, the Processor shall cease supplying the PMN substances to that recipient, shall notify EPA ofthe failure to comply, and shall resume supplying the PMN substances to thatrecipient only upon written notification from the Agency.

RELEASE TO WATER This provision does not supercede or preempt any applicable federal, state, or local laws and regulations. Those may be more stringent than the requirements below.II The Processor is prohibited from any predictable or purposeful 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 Processor shall maintain the following records until 5 years after the date they

are created and shall make them available for inspection and copyingby EPA in accordance with section 11 ofTSCA: (1) Exemptions. Records documenting that the PMN substances did in fact qualify for any
one or more ofthe exemptions describedin Section I, Paragraph (b) ofthis Order. Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemptionbeing claimed by the Processor. Any amounts or batches ofthe PMN substances eligible for the Export exemptionin 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 oftheir creation, copies ofthe export label and export notice to EPA, required by TSCA sections 12(a)(1)(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 years 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 inparagraph (2) below, but is exempt from the otherrecordkeeping requirements inthis Recordkeeping section;12 (2) Records documenting the names and addresses (including shipmentdestination address, ifdifferent) ofall persons outside the site ofmanufacture or importto whom the Processor directly sells ortransfers the PMN substances, the date ofeach sale ortransfer, and the quantity of the substances sold ortransferred 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 pursuantto the Protectioninthe Workplace section ofthis Order; (5) Records documenting the determinations required bythe Protection in the Workplace section ofthis Orderthat chemical protective clothing is impervious to the PMN substances; (6) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions in the Manufacturing, Processing, and Use, and Distribution sections ofthis Order, including distributees' written agreementto comply with the 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 sites where the PMN substances are processed.

(b) .App!icabilitv. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Processor, and not to activities ofthe Processor's customers.13 (c) OMB Control Number. Underthe Paperwork Reduction Act and its regulations at 5 CFRPart 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 number from the Office of Management and Budget ("OMB"), and EPA so informs the Processor. The "collection of information" required inthis TSCA §5(e) Consent Orders has been approved under currently valid OMB Control Number 2070-0012.

IV. REQUESTS FORPRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuantto section 11 ofTSCA and40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofProcessor facilities and conveyances associated with the PMN substances. To facilitate such inspections, EPA personnel may contact the Processor in advance to request information pertinentto the scheduling and conduct ofsuch inspections. Such requests may be written or oral. The types ofinformation thatEPA may request may include, but are not limited to, the following: (i) Expected dates and times when the PMN substances will be processed within the 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 exposed to the PMN substances; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to the PMN substances; (v) Records required bythe Recordkeeping section ofthis Order; and/or14 (vi) Any other information reasonably related to determining compliance with this Order or conducting an inspection for 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'srequest. Whenrequested in writing by EPA, the Processor's response shall be in writing. To the extent the information is known to orreasonably ascertainable to the Processor at the time oftherequest, 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 EPApursuantto paragraph (b) shall be protected in accordance with §14 of TSCA and 40 CFR Part 2.

V. MODIFICATION AND REVOCATION OF CONSENT ORDER The conditions ofthis Order (except the provisions regarding the retention ofrecords described in III(a), the Recordkeeping section) shall expire 75 days after promulgation ofa final significant newuse rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA, unless the Processor is notified on or before that day ofan action in a Federal Court seeking judicialreview 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 SNUR affirmed. Prior to the promulgation ofthe final SNUR, the Processor may petition EPA at any time,

### 15 based upon new infonnation on the health effects of, orhuman exposure to, the PMN substances, to modify or revoke substantive provisions ofthis Order. The exposures and risks identifiedby EPA during its review ofthe PMN substances and the infonnation EPA detennined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in detennining whether to amend or revoke this Order, EPA will consider all relevant infonnation available at the time the Agency makes that detennination, including, where appropriate, any reassessment ofthetest data or other infonnationthat supports the findings inthis Order, an examination ofnew test data or other information or analysis, and any other relevant infonnation. EPA will issue a modification or revocation ifEPA detennines that the activities proposed therein will not present an umeasonable risk ofinjury to health or the environment and will not result in significant or substantial human exposure or substantial environmental release inthe absence ofdata sufficient to pennit a reasoned evaluation ofthe health orenvironmental 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 the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.16 

### VI. EFFECT OF CONSENT ORDER By consenting to the entry ofthis Order, the Processor waives its rights to file objections to this Orderpursuantto section 5(e)(1)(C) ofTSCA, to receive service ofthis Order no later than 45 days before the end ofthe review periodpursuantto section 5(e)(1)(B) ofTSCA, and to challenge the validity ofthis Order in any subsequent action. Consentingto the entry ofthis Order, and agreeing to be boundby its terms, do notconstitute an admissionbythe Processor as to, the facts

or conclusions underlying the Agency's determinations 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 reviewedthis document and hereby agrees that all informationherein that is claimed as confidential by the Processor (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, and 40 CFRPart 2) is correctly identified within brackets and that any information that is not bracketed is not claimed as confidential. To make this document available for public viewing, EPA will remove only the information contained within 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 in accordance with the nomenclature system developedbythe International Union ofPure and Applied Chemistry orthe Chemical Abstracts Service's rules ofnomenclature, or a name whichwill 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 body protective clothing, boots, coveralls, gloves,jackets, and pants. "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 or painting contractor). "Commonname" 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 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, or for any personal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, or as part ofa mixture, sold or made available to consumers for their use in or around a permanent ortemporary household or residence, in or around a school, or in 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 or piping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Contract Manufacturer" means a person, outsidethe Company, who is authorized to manufacture and import the PMN substance under the conditions specified in Part II. ofthis Consent Order and inthe Consent Order for ContractManufacturer. "Identity" means any chemical or common name used to identify a chemical substance or a mixture containingthat substance.2 "Immediate use." A chemical substance is for the "immediate use" ofa person ifit is under the control of, andused only by, theperson who transferred itfrom a labeled container and will only be used by that person within the work shift in which it is transferred from the labelled container. "Impervious." Chemical protective clothing is "impervious" to a chemical substance ifthe substance causes no chemical 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 U.S. Department ofHealth and Human Services. "Non-enclosed process" means any equipment system (such as an open-top reactor, storage tank, or mixing vessel) in which a chemical substance is manufactured, processed, or otherwise used where significant direct contact ofthe bulk chemical substance and the workplace air may occur. "Non-industrial use"means use other than at a facility where chemical substances or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described inthe Premanufacture notice submittedbythe Company relevant to this Order. "Personal protective equipment" means any chemical protective clothing or device placed onthe bodyto prevent contact with, and exposure to, an identified chemical substance or substances inthe work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types ofrespirators. Barrier creams are not included in this definition. "Process" means the preparation ofa chemical substance or mixture, 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 in which it was received by the person so preparing such substance or mixture, or (B) as part ofan article containing the chemical substance ormixture. "Processor" means the person orpersons subjectto this Consent Order for Processor. "Process stream" means all reasonably anticipated transfer, flow, or disposal 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 CFR Part 792 without prior or subsequent Agency approval that prevents 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 permita reasoned evaluation of the potential risk ofinjury to humanhealth or the environment ofthe PMN substance. "Sealed container" means a closed containerthat 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, 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 forth in 40 CFR 122.2. "Work area" means a room or defined space in a workplace where the PMN substance is manufactured, processed, or used and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.