UNITED STATES ENVIRONMENTAL PROTECTIONAGENCY OFFICE OF POLLUTION PREVENTION AND TOXICS

REGULATION OFNEW CHEMICAL SUBSTANCE

PENDING DEVELOPMENT OF INFORMATION 

# -:21( It(l,fto

# ~llqlff!

Inthe matter of: ) ) ) ) 

### ) ) 

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

### ) ) ) ) ) ) ) ) ) ) ) PremanufactureNotice Number:

Konarka Technologies, Inc. P-09-4l6

Consent Order and Determinations Supporting Consent Order

### ii
TABLE OF CONTENTS

Preamble I. Introduction II. Summary ofTerms ofthe Order 

### III. Contents ofPMN IV
. EPA's Assessment ofRisk V. EPA's Conclusions ofLaw VI. Information Required to Evaluate Human Health Effects

Consent Order I. Scope ofApplicability and Exemptions II. Terms ofManufacture, Import, Processing, Distribution in Commerce, Use, and Disposal Pending Submission and Evaluation ofInformation 

### III. Recordkeeping IV. Requests for Pre-Inspection Information V. Successor Liability Upon Transfer ofConsent Order VI. Modification and Revocation ofConsent Order VII. Effect ofConsent Order Attachment A - Definitions Attachment B - Notice ofTransfer ofConsent Order111 

## PREAMBLE I. INTRODUCTION Under the authority of§.S(e) ofthe Toxic Substance Control Act ("TSCA") (IS U.S.C. 2604(e)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached Order, regarding a premanufacture notice ("PMN") P-09-416 for a composition ofthe following chemical substances, 3'H-Cyclopropa[1,9][S,6]fullerene-C60-Ih-3'-butanoic acid, 3'- phenyl-, methyl ester (CAS No: 160848-22-6), 3'H-Cyciopropa[8,2S][S,6]fullerene-C70-DSh(6)- 3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3), and 3'H-Cyclopropa[7,22][S,6]fullerene-C70-DSh(6)-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 10S1371-21-1) (the "PMN substance") submitted by Konarka Technologies, Inc. ("the Company"), to take effect upon expiration ofthePMN review period. The Company submitted the PMN to EPApursuantto section S(a)(l) ofTSCA and 40 CFR Part 720.

Under § IS ofTSCA, it is unlawful for any personto fail or refuse to comply with any provision of § S or any order issued under § S. Violators may be subject to various penalties and to both criminal and civil liability pursuantto § 16, and to specific enforcement and sei=e pursuant to § 17. In addition, chemical substance subjectto an Order issued under § 5 of TSCA, such as this one, are subject to the § 12(b) exportnotice requirement.

II. SUMMARY OF TERMS OF THE ORDER The Consent Order for this PMN substance requires the Company to: (1) Submit to EPA certain health test databefore exceeding a specified importvolume or aIV specifiedtime period; (2) Provide workers with impervious gloves and chemical protective clothing; (3) Provide workers with a NIOSH-approved full-face respirator with an N -100 cartridge when exposed by inhalation inthe work area; (4) Use the PMN substance only as an acceptor molecule in a polymer coating in an encapsulated organic photovoltaic electronic device; (5) Distribute the PMN substance onlyto a person who agrees to follow the same restrictions (except the testing requirements); (6) Not manufacture the substance in the United States; (7) Comply with the Release to Waterprovisions; and (8) Maintain certain records.



### III. CONTENTS OF PMN By signing this Order, the Company represents thatit has carefully reviewed this document and hereby agrees that all information herein that is claimed as confidential bythe Company (per section 14 ofTSCA, 40 CFR

### Part 720 Subpart E, and 40 CFR Part 2) is correctly identified within brackets and that any informationthat is not bracketed is not claimed as confidential. To make this document available for public viewing, EPAwill remove only the information contained within the brackets. Confidential Business Information Claims (Bracketed in the Preamble and Order): Companytechnical contact, productionvolume, impurities, molecular formula, byproducts, human exposure and environmental release, and operation/process information.v Chemical Identity: 3'H-Cyclopropa[I,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No: 160848-22-6), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'- butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3), and 3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 1051371-21-1). Use: as an acceptor molecule in a polymer coating in an encapsulated organic photovoltaic electronic device. Maximum 12-MonthProduction Volume: [] kglyr. 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 substance, based onthe information currently available to the Agency. Human Health Effects Summary: Absorption ofthe chemicals is expectedto be poorviaall routes ofexposure based ontest data for chemicals with similar molecular structures and chemicals with similarphysical/chemical properties. Toxicological Endpoints ofConcern: There is concern for lung effects based on the 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 oflessvi

than 10 microns, there is potential risk for adverse lung effects including cancer, lung fibrosis, lung inflanunation and systemic effects, including immunotoxicity, ifinhaled. The PMN substance may induce gene mutation in bacterial cells and in mammalian cells in culture and 

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

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

### in vivo. There is concernthat the PMN substance may disperse/disaggregate in the lung fluids to nanoscle particles. Hence, there is a concern for systemic effects ofnanoparticles beyond the lungs, including adverse cardio-vascular effects. Based onpublished scientific data, some nanoparticies appear to have immunotoxicity hazard potential. Pulmonary exposure to these PMNs may lead to toxicity to alveolar macrophage, impaired clearance ofinhaled bacteria and possible systemic immunosuppression. Occupational Exposure TABLE I (P09-416) Scenario # Sites # Workers Inhal (mg/d) Derm(mg/d) Processing: 

## [1 [1 0.11 12 (solid) Encapsulated 23 (mist) Photovoltaic Modules

Consumer Exposure: Consumer exposure is not expected because PMN is incorporated into a polymer within encapsulated photovoltaic modules. Risk to Workers. Table I indicates an inhalation exposure value (0.11 mg/day/individual) during processing ofthe PMN. This value of0.11, divided by 10m3 inhaled by a worker each work day, yields an inhalation exposure concentration of0.011 mg/m3 A New Chemical Exposure Limit, NCEL, of0.025 mg/m3 was derived from a study by Heinrich et al. (Inhalationvii Toxicology, 7(4):533-536, May 1995) on chronic carcinogenesis from carbon-based ultrafine diesel exhaust soot particles. The worst case worker inhalation exposure of0.011 mg/m3 for P09-416 during manufacturing is slightly less than the NCEL of0.025 mg/m3 for diesel exhaust soot.



### V. EPA'S CONCLUSIONS OF LAW The foIJowing findings constitute the basis ofthe Consent Order: (a) EPA is unable to determine the potential for humanhealth effects from exposure to the PMN substance. EPA therefore concludes, pursuantto § 5(e)(I)(A)(i) ofTSCA, that the information available to the Agency is insufficientto permit a reasoned evaluation ofthe human health effects ofthe PMN substance.

(b) 

### In light ofthe potential riskto human health posed by the uncontrolJed manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance, EPAhas concluded, pursuantto 

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



### VI. INFORMATION REOUIRED TO EVALUATE HEALTH EFFECTS Triggered Testing. The Orderprohibits the Company from exceeding a specified production time period orproductionvolume unless the Company submits the informationviii
described inthe Testing section ofthis Order in accordance withthe conditions specified inthe Testing section. Pended Testing. The following additional information wouldberequired to evaluate human health effects whichmay be caused by the PMN substance: I. Dispersion and solubility in fresh water, without the use of dispersants/solvents Refs for dispersion/solubility method: "Napthalene adsorption and desorption from aqueous C60 fullerene". 1. Chern Eng Data 

### 2004, 49, 675-683; and "Comparison of electrokinetic properties ofcolloidal fullerenes (n-c60) formed using two procedures". Env. Sci. & Techno!' 

### 2005, 39, 6343-6351. 2. Aquatic invertebrate chronic toxicity test, freshwater daphnids

- OCSPP 850.1300 Daphnid Chronic Toxicity Test. The Order does not require submission ofthe above pendedtesting at any specified time or production volume. However, the Order's restrictions on manufacture, import, processing, distribution in commerce, use, and disposal ofthe PMN substance will remain in effect until the Order is modified or revoked by EPA based on submission ofthat or otherrelevant information.IX

## CONSENT ORDER I. SCOPE OF APPLICABILITY AND EXEMPTIONS (a) Scope. The requirements ofthis Order apply to all commercial mannfacturing, processing, distribution in commerce, use and disposal ofthe mixture ofthe following chemical substance, 3'H-Cyclopropa[l,9] [5,6]fullerene-C60-Ih-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No: 160848-22-6), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'

- butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3), and 3'HCyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3'-phenyl-, methyl ester (CAS No. 1051371-21-1) (the "PMN substance"), inthe United States by Konarka Technologies, Inc. ("the Company"), except to the extent that those activities are exempted by paragraph (b). (b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance are exempt from the requirements ofthis Order (except the requirements in the Recordkeeping and Successor Liability Upon Transfer OfConsent Order sections) only to the extentthat (I) these activities are conducted in full compliance with all applicable requirements ofthe following exemptions, and (2) such compliance is documented by appropriate recordkeeping as required in the Recordkeeping section ofthis Order. (I) Completely Reacted (Cured). The requirements ofthis Order do not apply to2 quantities ofthe PMN substance that have been (i) completely reacted (cured); (ii) incorporated

or embedded into a polymermatrixthat 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 720.3(c). (2) Export. Until the Company begins commercial manufacture ofthe PMN substance for use inthe United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe PMN substance solely for export in accordance with TSCA §12(a) and (b), 40 CFR720.3(s) and 40 CFRPart 707. However, once the Company begins to manufacture the PMN substance for use in the United States, no further activities by the Company involving the PMN substance are exempt as "solely for export" even ifsome amounts ofthe PMN substance are later exported. Atthat point, the requirements ofthis Order apply to all activities associated with the PMN substance while in the territory ofthe United States. Prior to leaving U.S. territory, even those quantities orbatches ofthe PMN substance that

are destined for export are subject to terms ofthe Order, and counttowards any production volume testtriggers in the Testing section ofthis Order. (3) Research & Development ("R&D"). The requirements of this Order do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe PMN substance in small quantities solely for 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 substance whenthey are produced, without separate commercial intent, only as "byproducts" as defined at 40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g).3 (5) No Separate Commercial Purpose. The requirements ofthis Order do not apply to the PMN substance whenthey are manufactured, pursuant to any ofthe exemptions in 40 CFR 720.30(h), with no commercial purpose separate from the substance, mixture, or article ofwhich they are a part.

(c) Automatic Sunset. Ifthe Companyhas obtained for the PMN substance a Test Market Exemption ("TME") under TSCA §5(h)(J) and 40 CFR720.38 or a LowVolume Exemption ("LVE") or Low Release and Exposure Exemption ("LoREx") under TSCA §5(h)(4) and 40 CFR 723.50(c)(l) 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,

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OF INFORMATION
PROHIBITION The Company is prohibited from manufacturing, importing, processing, distributing in commerce, using, or disposing ofthe PMN substance inthe United States, for any nonexempt commercial purpose, pendingthe development ofinformation necessary for a reasoned evaluation ofthe human health effects ofthe substance, and the completion ofEPA's review of, and regulatory action based on, that information, except in accordance with the conditions described inthis Order.4

TESTING (a) Section 8ee) Reporting. Any information onthe PMN substance which reasonably supports the conclusion that the PMN substance present a substantial risk ofinjury to health orthe environment required to be reported under EPA's section 8(e) policy statement at 43 Federal Register 11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003) and 70 Federal Register 2162 (January 12,2005), shall reference the appropriate PMN identification numbers for these substance and shall contain a statementthat the substance are subject to this Consent Order. Additional information regarding section 8(e) reporting requirements can be found in the reporting guide referenced at 56 Federal Register 28458 (June 20,1991).

(b) Notice ofStudy Scheduling. The Company shall notify, 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 IS days after the effective date ofthis Order, whichever is**later~** (I) The date when the study is scheduled to commence; (2) The name and address ofthe laboratory which will conductthe study; (3) The name and telephone number ofa person at the Company or the laboratory whom EPA may contact regarding the study; and (4) The appropriate PMN identification numbers for the substance and a statementthat the substance is subjectto this Consent Order.5 (c) Good Laboratory Practice Standards and Test Protocols. Each studyrequiredto be performed pursuantto this Ordermust be conducted according to TSCA Good Laboratory Practice Standards at 40 CFRPart 792 and using methodologies generally accepted inthe relevant scientific community atthe time the study is initiated. Before starting to conduct any such study, the Company must obtain approval oftest protocols, including selection ofthetest substance, from EPA by submitting writtenprotocols. EPA will respond to the Companywithin 4 weeks ofreceiving the written protocols. Published test guidelines specified in paragraph (d) provide general guidance for development oftestprotocols, but are notthemselves acceptable protocols. Approval ofthe test protocol does notmean pre-acceptance oftestresults.

(d) Triggered Testing Requirements. (1) 90-day inhalationtoxicity test. The Company is prohibited importing the PMN substance beyond the following import volume ofthe PMN substance or beyond the specified time period, whichever comes first ("the production limit"), unless the Company conducts the following test onthe PMN substance and submits all final reports andunderlying datain accordance withthe conditions specified in this Testing section. The production limit shall be calculated startingtwo years after the expiration ofthe PMN reviewperiod. Production Limit 

## [1 year(s) and [ 

## 1 month(s) or [ 

## 1kg, whichever comes first Test Guideline 90-day inhalationtoxicity OPPTS 870.3465 study on rats with a post-exposure or OECD 413

observation period ofup to 3 months, including bronchoalveolar lavage fluid ("BALF") analysis, a determination ofcardiovascular toxicity (clinically-based blood/plasma protein analyses), and histopathology of the heart along with data on pulmonary deposition,6 clearance half-life (biopersistence) and translocation ofthe test material and particle size distributions prior to, and during, the inhalation tests.
Ifan appropriate adaptation ofthe 90-day inhalation study for the evaluation ofthe PMN substance is not developed within two years after the Company signs this Consent Order or ifthe Company commits to an appropriate program to test the substance, e.g., under the in-depth portion ofthe Nanoscale Materials Stewardship Program, the Companymay petition EPA, pursuant to Section VI ofthis Consent Order, to modify the above testing requirement. Ifa consortium ofcompanies commits to testrepresentative substance for subchronic mammalian toxicity, EPA will consider waiving the above requirement. (2) Physical/chemical properties. Ifthe Company owns or controls any site inthe United States where the PMN substance are processed orused, the Company must submit the following material characterization data within 6 months after the expiration ofthe PMN review period: 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; Particle size distribution that includes both individual PMN substance and their agglomerates as used in the workplace at sites controlledby the Company where the PMN substance are processed or used: TEM (transmission electron microscope), SEM (scanning electron microscope) using a dry particle counting method, and no counting after dispersion in a solution and evaporating solvent); and Dustiness test (EN 15051 method) Description ofthe physical-chemical properties ofthe material tested should take into considerationthe characterizations identified in the Guidance Manual for the Testing of Manufactured Nanomaterials: OECD's Sponsorship Programme.7 (e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in a scientificallyvalid manner; (2) promptly furnish to EPA the results ofany interim phase of each study; and (3) submit, in triplicate (with an additional sanitized copy, ifconfidential business information is involved), the final report ofeach study and all underlying data ("the report and data") to EPA no later 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 in the applicable test guidelines. However, for purposes ofthis Consent Order, the word "should" in those subparagraphs shall be interpretedto mean "shall" to make clear that the submission ofsuch information is mandatory. EPA will notrequire the submission ofraw data such as slides and laboratory notebooks unless ifEPA finds, on the basis ofprofessionaljudgment, that an adequate evaluation ofthe study cannot take place in the absence ofthese items.

(f) Testing Waivers. The Company is not required to conduct a study specified inparagraph (d) ofthis Testing section ifnotified in writing byEPAthat it is unnecessary to conduct that study.

(g) Equivocal Data. IfEPA finds that the data generated by a study are scientifically equivocal, the Company may continue to manufacture and import the PMN substancebeyondthe applicable production limit. To seek relieffrom any other restrictions ofthis Order, the Company may make a second attempt to obtain unequivocal data by reconducting the study under the conditions specified inparagraphs (b), (c), and (e)(1) and (2). The testing requirements may be modified, as8 necessary to permit a reasoned evaluation ofthe risks presentedbythe PMN substance, only by mutual consent ofEPA and the Company.

(h) EPA Determination ofInvalid Data. (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 prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Company may continue to manufacture and import the PMN substance beyondthe applicable production limit only ifso notified, in writing, by EPA in response to the Company's compliance with either ofthe following subparagraphs (h)(2)(i) or (h)(2)(ii). (i) The Company may reconduct the study in compliance withparagraphs (b), (c), and (e)(1) and (2). Ifthere is sufficient time to reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the production limit as required by subparagraph (e)(3), the Company shall comply with subparagraph (e)(3). Ifthere is insufficient time for the Company to complywith subparagraph (f)(3), the Company may exceed the production limit and shall submitthe report and datain triplicate to EPAwithin a reasonable period oftime, all as specified byEPA inthe notice described in subparagraph (h)(1). EPA will respond to the Company, in writing, within 6 weeks ofreceiving the Company's report and data. (ii) The Company may, within4 weeks ofreceiving from EPA the notice described in subparagraph (h)(I), submit to EPA a written report refuting EPA's finding. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report.9 (i) Company Determination ofInvalid Data. (l)Except as described in subparagraph (i)(2), ifthe Companybecomes aware that circumstances clearly beyond the control ofthe Company or laboratory will prevent, or have prevented, development ofscientifically valid dataunder the conditions specified in paragraphs (c) and (e), the Company remains prohibited from further manufacture and import ofthe PMN substance beyond the applicable production limit. (2) The Company may submitto EPA, within 2 weeks offirst becoming aware ofsuch circumstances, a written statement explaining why circumstances clearly beyond the control ofthe Company or laboratory will cause or have caused development ofscientifically invalid data. EPA will notifY the Company ofits response, in writing, within4 weeks ofreceiving the Company's report. EPA's writtenresponse may either: (i) allow the Companyto continue to manufacture and importthe PMN substance beyondthe applicable production limit, or (ii) require the Company to continue to conduct, orto reconduct, the study in compliance with paragraphs (b), (c), and (e)(l) and (2). Ifthere is sufficienttime to conduct or reconduct the study and submit the report and data to 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 exceedthe 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 (i)(2). EPA will respond to the Company, inwriting, within 6 weeks ofreceiving the Company's report and data, as to whether the Company may continue to manufacture and importbeyondthe applicable production limit.10

0) Unreasonable Risk. (l) EPA may notify the Company in writing thatEPA finds thatthe data generated by a study are scientifically valid and unequivocal and indicate that, despite the terms ofthis Order, the PMN substance will or may present anunreasonable risk ofinjury to human health orthe environment. EPA's notice may specifythat the Company undertake certain actions concerning further testing, manufacture, import, processing, distribution, use and/or disposal ofthe PMN substance to mitigate exposures to orto better characterize the risks presented by the PMN substance. Within 2 weeks from receipt ofsuch a notice, the Company must cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance, unless either: (2) within 2 weeks from receipt ofthe notice described in subparagraph O)(l), the Company complies with such requirements as EPA's notice specifies; or (3) within 4 weeks from receipt ofthe notice described in subparagraph 0)(I), the Company submits to EPA a writtenreport refuting EPA's finding and/orthe appropriateness of any additional requirements imposed by EPA. The Company may continue to manufacture, import, process, distribute, use and dispose ofthe PMN substance in accordance withthe terms of this Orderpending EPA's response to the Company's written report. EPA will respond to the Company, in writing, within 4 weeks ofreceiving the Company's report. Within 2 weeks of receipt ofEPA's written response, the Company shall comply with any requirements imposedby EPA's response or cease all manufacture, import, processing, distribution, use and disposal ofthe PMN substance.11 (k) Other Requirements. Regardless ofthe satisfaction ofany other conditions in this Testing section, the Company must continue to obey all the terms ofthis Consent Order until otherwise notified in writing by EPA. The Company may, based upon submitted test data or other relevant information, petition EPA to modify or revoke provisions ofthis Consent Orderpursuantto Part VI ofthis Consent Order.

PROTECTION IN THE WORKPLACE (a) Establishment ofProgram. During manufacturing, processing, and use ofthePMN substance at any site controlled by the Company (including any associated packaging and storage and during any cleaning or maintenance ofequipment associated with the PMN substance), the Company mustestablish a program whereby: (I) General Dermal Protection. Each person who is reasonably likely to be dermally exposed inthe work area to the PMN substance through direct handling ofthe substance or through contact with equipment on whlch the substance may exist, orbecause the substance become airborne in a form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, personal protective equipmentthat provides a barrier to prevent dermal exposure to the substance inthe specific work area where the substance are selected for use. Each such item ofpersonal protective equipment must be selected and used in accordance with OSHA dermal protectionrequirements at29 CFR 1910.132,1910.133, and 1910.138. (2) Suecific Dermal Protective Eguiument. The dermal personal protective equipment required by subparagraph (a)(I) ofthis section must include, but is not limited to, the following items:12 (i) Gloves impervious to the PMN substance (ii) Full body clothing impervious to the PMN substance (3) Demonstration ofImperviousness. The Company is able to demonstrate that each item ofchemical protective clothing selected, including gloves, provides an impervious barrierto prevent dermal exposure during normal and expected duration and conditions ofexposure within the work area by anyone or a combination ofthe following: (i) Permeation Testing. Testingthe material used to make the chemical protective clothing and the construction ofthe clothingto 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 substance to which the clothing may be exposed inthe work area. Permeationtesting 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 berecorded as a cumulative permeation rate as a function oftime, and shall be documented in accordance with ASTM F739 using the format specified in ASTM Fl194-89 "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 whichthey are exposed to the PMN substance. (ii) Manufacturer's Specifications. Evaluating the specifications from the manufacturer or supplier ofthe chemical protective clothing, or ofthe material used in construction ofthe clothing, to establish that the chemical protective clothing will be impervious to the PMN substance alone and in likely combination with other chemical substance in the work13

area. (4) Respiratory Protection. Each person who is reasonably likelyto be exposed by inhalation inthe work areato the PMN substance inthe form listed in subparagraph (a)(5) ofthis section, is provided with, and is required to wear, at a minimum, a NIOSH-certifiedrespirator from the respirators listed in subparagraph (a)(6) ofthis section, and the respirator is used in accordance with the Occupational Safety and Health Administration ("OSHA") and NIOSHrespiratory 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 substance 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 meetthe 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 suggestthe manufacture or import ofthe PMN substance by any other person. (2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation ofa final significantnewuse rule ("SNUR") governing the PMN substance under section 5(a)(2) of TSCA unless the Company is notified on or before that day ofan action in a Federal Court seeking judicial review ofthe SNUR. Ifthe Company is so notified, subparagraph (a)(l) shallnot expire14 until EPAnotifies the Company in writing that all Federal Court actions involving the SNURhave been resolved and the validity ofthe SNURaffirmed. (3) Notice ofSNUR. When EPA promulgates a final SNUR for the PMN substance and subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each personwhom it causes, encourages or suggests to manufacture or importthe PMN substance ofthe existence ofthe SNUR. (b) Prohibited Uses. The Company shall not manufacture the PMN substance in the United States.

PROCESSING AND USE The Company shall notprocess or use the PMN substance otherthan as an acceptor molecule in a polymer coating in an encapsulated organic photovoltaic electronic devices.

RELEASE TO WATER This provision does not supercede or preempt any applicable federal, state, or local laws and regulations. Those may be more stringentthan the requirements below. The Company is prohibited from any predictable or purposeful release ofthePMN substance, or any waste stream from processing and use containing the PMN substance, into the waters ofthe United States.15 

### III. RECORDKEEPING (a) Records. The Company shan maintainthe fonowing records until 5 years after the date they

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

one or more ofthe exemptions described in Section I, Paragraph (b) ofthis Order. Such records must satisfy an the statutory and regulatoryrecordkeeping requirements applicable to the exemptionbeing claimed by the Company. Any amounts or batches ofthe PMN substance eligible for the Export exemption in Section I, Paragraph (b)(2) ofthis Order, are exempt from an 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, requiredby TSCA sections 12(a)(I)(B) and 12(b), respectively. Any amounts orbatches ofthe PMN substance eligible for the Research and Development exemption in Section I, Paragraph 

### (b)(3) ofthis Order,

are exempt from an the requirements in this Recordkeeping section, ifthe Company maintains, for 5 years from the date oftheir creation, the records requiredby 40 CFR 

### nO.78(b). For any amounts or batches ofthe PMN substance claimed to be eligible for any other exemption described in Section I, Paragraph (b) ofthis Order, the Company shall keep records demonstrating qualification for that exemption as wen as the records specified inparagraphs (2) and (3) below, but is exempt from the other recordkeeping requirements in this Recordkeeping section; (2) Records documenting the manufacture and importationvolume ofthe PMN substance andthe corresponding dates ofmanufacture and import; (3) Records documenting the names and addresses (including shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture or importto whom the Company16 directly sells ortransfers the PMN substance, the date ofeach sale ortransfer, and the quantity of the substance sold ortransferred on such date; (4) Records documenting the addresses ofall sites ofmanufacture, import, processing, and use; (5) Records documenting establishment and implementation ofa program for the use of any applicable personalprotective equipmentrequired pursuant to the Protection in the Workplace section ofthis Order; (6) Records documenting the determinations required by the Protection in the Workplace section ofthis Order that chemical protective clothing is impervious to the PMN substance; (7) Records documenting compliance with any applicable manufacturing, processing, use, and distribution restrictions inthe Manufacturing, Processing and Use, and Distribution sections of this Order, including distributees' written agreementto comply with the Distribution section ofthis Order; (8) Records documenting compliance with the Release to Water provisions; (9) Copies ofany TransferDocuments 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 substance are manufactured ofimported.

(a) Applicabilitv. The provisions ofthis Recordkeeping Section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Company's customers.17 (b) OMB Control Number. Underthe Paperwork Reduction Act and its regulations at 5 CFRPart 1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of information" unless this Order displays a currently valid control number from the Office of Management and Budget ("OMB"), and EPA so informs the Company. The "collection of information" required in this TSCA §5(e) Consent Orders has been approved under currently valid OMB Control Number 2070-0012.

IV. REOUESTS FOR PRE-INSPECTION INFORMATION (a) EPA's Request for Information. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA may occasionally conduct on-site compliance inspections ofCompany facilities and conveyances associated with the PMN substance. To facilitate such inspections, EPApersonnel may contactthe Company in advance to request information pertinentto the scheduling and conduct ofsuch inspections. Suchrequests may be written or oral. The types ofinformation that EPA may request may include, but are not limitedto, the following: (i) Expected dates and times when the PMN substance will be inproduction within the subsequent 12 months; (ii) Current workshift schedules for workers who are involved in activities associated with the PMN substance and may reasonably be exposed to the PMN substance; (iii) Currentjobtitles or categories for workers who are involved inactivities associated with the PMN substance and mayreasonably be exposed to the PMN substance; (iv) Existing exposure monitoring data for workers who are involved in activities associated with the PMN substance and may reasonably be exposed to the PMN substance; (v) Records required by the Recordkeeping section ofthis Order; and/or18 (vi) Any other information reasonably related to determining compliance withthis Order or conducting an inspection for thatpurpose.

(b) Company's Response. The Company shall respond to such requests within a reasonable period oftime, but in no event later than 30 days after receiving EPA's request. When requested in writing by EPA, the Company's response shall be in writing. To the extentthe information is known to or reasonably ascertainable to the Company at the time ofthe request, the Company's response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests.

(c) Confidential Business Information. Any Confidential Business Information ("CBI") thatthe 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 whichthe Company's rights and obligations under this Order may be transferred when the Company transfers its interests inthe PMN substance, including the right to manufacture the PMN substance, to another person outside the Company (the "Successor in Interest").

(b) Relation ofTransfer Date to Notice ofCommencement ("NOC"). (1) Before NOC. Ifthe transfer from the Companyto the Successor in Interestis effective before EPA receives a notice ofcommencement ofmanufacture or import ("NOC") for the PMN19 substance from the Company pursuant to 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 substance. (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 withthe terms ofthis Order and shall not be required to submit newPMNs to EPA.

(c) Definitions. The following definitions apply to this Successor Liability section ofthe Order: (I) "Successor in Interest" means a person outside the Company who has acquired the Company's full interest inthe rights to manufacture the PMN substance, including all ownership rights and legal liabilities, through a transfer document signed by the Company, as transferor, and the Successor in Interest, as transferee. The term excludes persons who acquire less than the full interest ofthe Company inthe PMN substance, such as a licensee who has acquired a limited license to the patent or manufacturing rights associated with the PMN substance. A Successor in Interest must be incorporated, licensed, or doing business in the United States in accordance with 40 CFR 720.22(a)(3). (2) "Transfer Document" means the legal instrument(s) used to convey the interests inthe PMN substance, including the rightto manufacture the PMN substance, from the Company to the Successor in Interest.

(d) Notices. (I) 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 Consent20 Order and the "Notice ofTransfer" document which is incorporated by reference as Attachment C to this Order. (2) Notice to EPA. Within 10 business days oftheeffective date ofthe transfer, the Company shall, by registered mail, submitthe fully executed Notice ofTransfer document to: U.S. Environmental ProtectionAgency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460. (3) Transfer Document. Copies oftheTransfer Documentmust be maintained by the Successor in Interest at its principal place ofbusiness, and at all sites where the PMN substance are manufactured or imported. Copies oftheTransfer Documentmust also be made available for inspectionpursuantto Section 11 ofTSCA, must state the effective date oftransfer, and must containprovisions which expressly transfer liability for the PMN substance under the terms ofthis Order from the Company to the Successor in Interest.

(e) Liability. (1) The Company shall be liable for compliance with the requirements ofthis Order until the effective date ofthe transfer described above. (2) The Successor in Interest shall be liable for compliance with the requirements ofthis Order effective as ofthe date oftransfer. (3) Nothing inthis section shall be construed to prohibitthe Agency from taking enforcement action against the Company after the effective date ofthe transfer for actions taken, or omissions made, during the time in which the Company manufactured, processed, used, distributed in commerce, or disposed ofthe PMN substance pursuantto the terms ofthis Consent Order.21

(f) Obligations to Submit TestDataunder Consent Order. Ifparagraph (d) ofthe Testing section ofthis Consent Order requires the Companyto submittest data to EPA at a specified production volume ("test trigger"), the aggregate volume ofthe PMN substance manufactured and imported bythe Company up to the date oftransfer shall count towards the testtrigger applicable to the Successor in Interest.

### 22 VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company may petition EPA at any time, based upon new information on the health effects of, or human exposure to, the PMN substance, to modify orrevoke substantive provisions ofthis Order. The exposures and risks identified by EPA during its review ofthe PMN substance and the information EPA determined to be necessary to evaluate those exposures and risks are described in the preamble to this Order. However, in determining whether to amend or revoke this Order, EPA will consider all relevant information available at the time the Agency makes that determination, including, where appropriate, any reassessment ofthe test data or other information that supports the findings in this Order, an examination ofnew test data or other information or analysis, and any otherrelevant information. EPA will issue a modification or revocation ifEPA determines that the activities proposed therein will not present an unreasonable risk ofinjury to health or the environment and will not result in significant or substantial human exposure or substantial environmental release in the absence ofdata sufficientto permit a reasoned evaluation ofthe health orenvironmental effects of the PMN substance. In addition, the Company may petition EPA at any time to make other modifications to the language ofthis Order. EPA will issue such a modification ifEPA determines that the modification is useful, appropriate, and consistent with the structure and intent ofthis Order as issued.23

Byconsenting to the entryofthis Order, theCompanywaives itsrights to file objections to this Orderpursuantto section 5(e)(1)(C) ofTSCA, to receive service ofthis Orderno later than 45 days beforethe end ofthe review periodpursuantto section5(e)(1)(B) ofTSCA, andto challenge thevalidity ofthis Orderin anysubsequent action. Consentingto the entry ofthis Order, and agreeingtobeboundbyits tenus, do not constitute an admissionbytheCompany as to, the facts

orconclusions underlying theAgency's determinations inthis proceeding. This waiver does not affect any otherrights thatthe Companymayhaveunder TSCA. Bysigningthis Order, the Companyrepresents thatithas carefullyreviewedthis document and hereby agrees that all informationhereinthat is claimed as confidential bythe Company (per section 14 ofTSCA, 40 CFR Part 720 SubpartE, and40 CFRPart2) is correctlyidentifiedwithin brackets and that anyinformationthat isnotbracketedis not claimed as confidential. To make this document available forpublic viewing, EPAwillremove onlythe information containedwithin thebrackets.

# fof,~

# /10 Date'

Date! 

## 7 Name: ;DavidWaller Title: Director ofMaterials and Chemistry Company: Konarka Technologies, Inc.ATTACHMENT A DEFINITIONS [Note: The attached Order may notcontain some of the terms definedbelow.] "Chemical name" means the scientific designation ofa chemical substance in accordance with the nomenclature system developed by the International Union ofPure and Applied Chemistry orthe Chemical Abstracts Service's rules ofnomenclature, ora name whichwill clearly identify a chemical substance for the purpose ofconducting a hazard evaluation. "Chemical protective clothing" means items ofclothingthat provide a protective barrier to prevent dermal contact with chemical substance ofconcern. Examples can include, but are not limited to: full body protective 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 or painting contractor). "Common name" means any designation or identification such as code name, code number, trade name, brand name, or generic chemical name used to identify a chemical substance other than by its chemical name. "Consumer" means a private individual who uses a chemical substance or any product containing the chemical substance in or around a permanent ortemporary household or residence, during recreation, or for any personal use or enjoyment. "Consumerproduct" means a chemical substance that is directly, oras 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, orthe like that contains a hazardous chemical. For purposes ofthis section, pipes orpiping systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be containers. "Contract Manufacturer" means a person, outside the Company, who is authorized to manufacture and import the PMN substance under the conditions specified in Part II. ofthis Consent Order and inthe Consent Order for 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 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, 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-enclosed process" 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 ofthe bulk chemical substance and the workplace air may occur. "Non-industrial use" means use other than at a facility where chemical substance or mixtures are manufactured, imported, orprocessed. "PMN substance" means the chemical substance described in the 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 substance in the work area. Examples include, but are not limited to, chemical protective clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and various types of respirators. Barrier creams are not included inthis definition. "Process stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of processing, including the cleaning ofequipment. "Scientifically invalid" means any significant departure from the EPA-approvedprotocol 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 ofthePMN substance. "Scientifically equivocal data" means data which, although developed in apparent3 confonnity withthe Good Laboratory Practice Standards and EPA-approved protocols, are inconclusive, internally inconsistent, or otherwise insufficient to pennit a reasoned evaluation of the potential risk ofinjury to human health or the environment ofthe PMN substance. "Sealed container" means a closed containerthat is physically and chemically suitable for long-tenn containment ofthe PMN substance, and from whichthere will be no human exposure to, nor environmental release of, the PMN substance during transport and storage. "Use stream" means all reasonably anticipated transfer, flow, or disposal ofa chemical substance, regardless ofphysical state or concentration, through all intended operations of industrial, commercial, or consumer use. "Waters ofthe United States" has the meaning set forth in40 CFR 122.2. "Work area" means a room or defined space in a workplace wherethe PMN substance is manufactured, processed, orused and where employees are present. "Workplace" means an establishment at one geographic location containing one ormore work areas.Company (Transferor) ATTACHMENT B NOTICE OF TRANSFER OF TOXIC SUBSTANCE 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 substance, which was the subject ofa premanufacture notice ("PMN") and is governed by a Consent Order issuedbythe U.S. Environmental Protection Agency ("EPA") under the authority of§5(e) ofthe Toxic Substance Control Act (TSCA, 15 U.S.c. §2604(e». 2. Assumption ofLiability. The Successor in Interest hereby certifies that, as ofthe effective date oftransfer, all actions or omissions governed by the applicable Consent Order limiting manufacture, processing, use, distribution in commerce and disposal ofthe PMN substance, shall be the responsibility ofthe Successor in Interest. Successorin Interest also certifies that it is incorporated, licensed, or doing business in the United States in accordance with 40 CFR nO.22(a)(3). 3. Confidential Business Information. The Successor in Interest hereby: reasserts,

_ relinquishes, or modifies all Confidential Business 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 beenpreviously disclosed to the public (e.g., a chemical identity that was not claimed as CBI bythe original submitter) would not subsequently be eligible for confidential treatment under this Notice ofTransfer.2 TOXIC SUBSTANCE CONTROL ACT

SECTION 5(e) CONSENT ORDER NOTICE OF TRANSFER (continued)

Company (Transferor) PMNNumber

Signature ofAuthorized Official Date

Printed Name ofAuthorized Official

Title ofAuthorized Official

Successor in Interest

Signature ofAuthorized Official Date

Printed Name ofAuthorized Official

Title ofAuthorized Official

Address City, State, Zip Code3



### TOXIC SUBSTANCE CONTROLACT

SECTION See) CONSENT ORDER NOTICE OF TRANSFER (continued)

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


### Phone