UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

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Premanufacture Notice Number: 

Konarka Technologies, Inc. P-09-4l6 

Consent Order and Determinations Supporting Consent Order 
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TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Terms of the Order 

III. Contents ofPMN 

IV . EPA's Assessment of Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

II. Terms of Manufacture, Import, Processing, Distribution in Commerce, Use, and Disposal 

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Notice of Transfer of Consent Order 
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PREAMBLE 

I. INTRODUCTION 

Under the authority of §. S( e) of the 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 of the 

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 ofthe PMN review period. The Company 

submitted the PMN to EPA pursuant to section S(a)(l) ofTSCA and 40 CFR Part 

720. 

Under § IS of TSCA, it is unlawful for any person to 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 pursuant to § 16, and to specific enforcement and sei=e 

pursuant to § 17. In addition, chemical substance subject to an Order issued under § 5 of TSCA, 

such as this one, are subject to the § 12(b) export notice requirement. 

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for this PMN substance requires the Company to: 

(1) Submit to EPA certain health test data before exceeding a specified import volume or a 
IV 

specified time 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 in the 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 only to 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 Water provisions; and 

(8) Maintain certain records. 

III. CONTENTS OF PMN 

By signing this Order, the Company represents that it has carefully reviewed this 

document and hereby agrees that all information herein that is claimed as confidential by the 

Company (per section 14 of TSCA, 40 CFR Part 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): 

Company technical contact, production volume, 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-Month Production 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 of the PMN substance, based on the information currently available to 

the Agency. 

Human Health Effects Summary: 

Absorption of the chemicals is expected to be poor via all routes of exposure based on test data 

for chemicals with similar molecular structures and chemicals with similar physical/chemical 

properties. 

Toxicological Endpoints of Concern: 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 other respirable, poorly soluble particles with diameter of less 
vi 

than 10 microns, there is potential risk for adverse lung effects including cancer, lung fibrosis, 

lung inflanunation and systemic effects, including immunotoxicity, if inhaled. 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 concern that the PMN substance may 

disperse/disaggregate in the lung fluids to nanoscle particles. Hence, there is a concern for 

systemic effects of nanoparticles beyond the lungs, including adverse cardio-vascular effects. 

Based on published scientific data, some nanoparticies appear to have immunotoxicity hazard 

potential. Pulmonary exposure to these PMN s may lead to toxicity to alveolar macrophage, 

impaired clearance of inhaled 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 of the PMN. This value of 0.11, divided by 10m3 inhaled by a worker each work 

day, yields an inhalation exposure concentration of 0.011 mg/m3 A New Chemical Exposure 

Limit, NCEL, of 0.025 mg/m3 was derived from a study by Heinrich et al. (Inhalation 
vii 

Toxicology, 7(4):533-536, May 1995) on chronic carcinogenesis from carbon-based ultrafine 

diesel exhaust soot particles. The worst case worker inhalation exposure of 0.011 mg/m3 for 

P09-416 during manufacturing is slightly less than the NCEL of 0.025 mg/m3 for diesel exhaust 

soot. 

V. EPA'S CONCLUSIONS OF LAW 

The foIJowing findings constitute the basis of the Consent Order: 

(a) EPA is unable to determine the potential for human health effects from exposure to the 

PMN substance. EPA therefore concludes, pursuant to § 5(e)(I)(A)(i) ofTSCA, that the 

information available to the Agency is insufficient to permit a reasoned evaluation of the 

human health effects of the PMN substance. 

(b) In light of the potential risk to human health posed by the uncontrolJed manufacture, 

import, processing, distribution in commerce, use, and disposal of the PMN substance, 

EPA has concluded, pursuant to § 5( e)(I )(A)(ii)(I) of TSCA, that uncontroIJed 

manufacture, import, processing, distribution in commerce, use, and disposal of the PMN 

substance may present an unreasonable risk of injury to human health. 

VI. INFORMATION REOUIRED TO EVALUATE HEALTH EFFECTS 

Triggered Testing. The Order prohibits the Company from exceeding a specified 

production time period or production volume unless the Company submits the information 
viii 

described in the Testing section of this Order in accordance with the conditions specified in the 

Testing section. 

Pended Testing. The following additional information would be required to evaluate 

human health effects which may 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 of colloidal 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 of the above pended testing at any specified time or 

production volume. However, the Order's restrictions on manufacture, import, processing, 

distribution in commerce, use, and disposal of the PMN substance will remain in effect until the 

Order is modified or revoked by EPA based on submission of that or other relevant information. 
IX 
CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

(a) Scope. The requirements of this Order apply to all commercial mannfacturing, processing, 

distribution in commerce, use and disposal ofthe mixture of the 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"), in the 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 of the 

PMN substance are exempt from the requirements of this Order (except the requirements in the 

Recordkeeping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

extent that (I) these activities are conducted in full compliance with all applicable requirements 

ofthe following exemptions, and (2) such compliance is documented by appropriate 

recordkeeping as required in the Recordkeeping section of this Order. 

(I) Completely Reacted (Cured). The requirements of this Order do not apply to 
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quantities of the PMN substance that have been (i) completely reacted (cured); (ii) incorporated 

or embedded into a polymer matrix that itself has 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 of the PMN substance 

for use in the United States, the requirements ofthis Order do not apply to manufacture, 

processing or distribution in commerce of the PMN substance solely for export in accordance 

with TSCA § 12(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 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 if some 

amounts of the PMN substance are later exported. At that point, the requirements of this Order 

apply to all activities associated with the PMN substance while in the territory of the United 

States. Prior to leaving U.S. territory, even those quantities or batches of the PMN substance that 

are destined for export are subject to terms of the Order, and count towards any production 

volume test triggers in the Testing section of this Order. 

(3) Research & Development ("R&D"). The requirements of this Order do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the 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 of this Order do not apply to the PMN substance 

when they are produced, without separate commercial intent, only as "byproducts" as defined at 

40 CFR 720.3(d) and in compliance with 40 CFR 720.30(g). 
3 

(5) No Separate Commercial Purpose. The requirements ofthis Order do not apply to 

the PMN substance when they are manufactured, pursuant to any of the exemptions in 40 CFR 

720.30(h), with no commercial purpose separate from the substance, mixture, or article of which 

they are a part. 

(c) Automatic Sunset. If the Company has obtained for the PMN substance a Test Market 

Exemption ("TME") under TSCA §5(h)(J) and 40 CFR 720.38 or a Low Volume Exemption 

("L VE") 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 of this 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 of the PMN substance in the United States, for any nonexempt 

commercial purpose, pending the development of information necessary for a reasoned 

evaluation ofthe human health effects of the substance, and the completion of EPA's review of, 

and regulatory action based on, that information, except in accordance with the conditions 

described in this Order. 
4 

TESTING 

(a) Section 8ee) Reporting. Any information on the PMN substance which reasonably supports 

the conclusion that the PMN substance present a substantial risk of injury to health or the 

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 statement that 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 of Study Scheduling. The Company shall notify, in writing, the EPA Laboratory 

Data Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. 

Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, 

of the following information within 10 days of scheduling any study required to be performed 

pursuant to this Order, or within IS days after the effective date of this Order, whichever is later~ 

(I) The date when the study is scheduled to commence; 

(2) The name and address of the laboratory which will conduct the study; 

(3) The name and telephone number of a 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 statement that 

the substance is subject to this Consent Order. 
5 

(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be 

performed pursuant to this Order must be conducted according to TSCA Good Laboratory 

Practice Standards at 40 CFR Part 792 and using methodologies generally accepted in the 

relevant scientific community at the time the study is initiated. Before starting to conduct any 

such study, the Company must obtain approval of test protocols, including selection of the test 

substance, from EPA by submitting written protocols. EPA will respond to the Company within 

4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (d) 

provide general guidance for development of test protocols, but are not themselves acceptable 

protocols. Approval of the test protocol does not mean pre-acceptance of test results. 

(d) Triggered Testing Requirements. 

(1) 90-day inhalation toxicity test. The Company is prohibited importing the PMN substance 

beyond the following import volume of the PMN substance or beyond the specified time 

period, whichever comes first ("the production limit"), unless the Company conducts the 

following test on the PMN substance and submits all final reports and underlying data in 

accordance with the conditions specified in this Testing section. The production limit shall 

be calculated starting two years after the expiration of the PMN review period. 

Production Limit 

[ 1 year(s) and [ 1 

month(s) or [ 1 kg, 

whichever comes 

first 

Test Guideline 

90-day inhalation toxicity OPPTS 870.3465 

study on rats with a post-exposure or OECD 413 

observation period of up to 3 months, 

including bronchoalveolar lavage fluid 

("BALF") analysis, a determination 

of cardiovascular 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 of the test material and 

particle size distributions prior to, and 

during, the inhalation tests. 

If an appropriate adaptation of the 90-day inhalation study for the evaluation of the PMN 

substance is not developed within two years after the Company signs this Consent Order or if the 

Company commits to an appropriate program to test the substance, e.g., under the in-depth 

portion of the Nanoscale Materials Stewardship Program, the Company may petition EPA, 

pursuant to Section VI of this Consent Order, to modify the above testing requirement. If a 

consortium of companies commits to test representative substance for subchronic mammalian 

toxicity, EPA will consider waiving the above requirement. 

(2) Physical/chemical properties. If the Company owns or controls any site in the 

United States where the PMN substance are processed or used, the Company must submit 

the following material characterization data within 6 months after the expiration of the 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 controlled by 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 of the physical-chemical properties of the material tested should take into 

consideration the characterizations identified in the Guidance Manual for the Testing of 

Manufactured Nanomaterials: OECD's Sponsorship Programme. 
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(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and 

in a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of 

each study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential 

business information is involved), the final report of each study and all underlying data ("the 

report and data") to EPA no later than 14 weeks prior to exceeding the applicable production 

limit. The final report shall contain the contents specified in 40 CFR 792.185. Underlying data 

shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", 

and "Test Report" subparagraphs in the applicable test guidelines. However, for purposes of this 

Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to 

make clear that the submission of such information is mandatory. EPA will not require the 

submission of raw data such as slides and laboratory notebooks unless if EPA finds, on the basis 

of professional judgment, that an adequate evaluation of the study cannot take place in the 

absence of these items. 

(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) 

of this Testing section if notified in writing by EPA that it is unnecessary to conduct that study. 

(g) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, 

the Company may continue to manufacture and import the PMN substance beyond the applicable 

production limit. To seek relief from any other restrictions of this Order, the Company may 

make a second attempt to obtain unequivocal data by reconducting the study under the conditions 

specified in paragraphs (b), (c), and (e)(1) and (2). The testing requirements may be modified, as 
8 

necessary to permit a reasoned evaluation of the risks presented by the PMN substance, only by 

mutual consent of EPA and the Company. 

(h) EPA Determination ofInvalid Data. 

(I) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt ofa 

test report and data, the Company receives written notice that EPA finds that the data generated by 

a study are scientifically invalid, the Company is prohibited from further manufacture and import 

of the PMN substance beyond the applicable production limit. 

(2) The Company may continue to manufacture and import the PMN substance beyond the 

applicable production limit only if so notified, in writing, by EPA in response to the Company's 

compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii). 

(i) The Company may reconduct the study in compliance with paragraphs (b), (c), 

and (e )(1) and (2). If there 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). If there is insufficient time for the Company 

to comply with subparagraph (f)(3), the Company may exceed the production limit and shall 

submit the report and data in triplicate to EPA within a reasonable period of time, all as specified 

by EPA in the notice described in subparagraph (h)(1). EPA will respond to the Company, in 

writing, within 6 weeks of receiving the Company's report and data. 

(ii) The Company may, within4 weeks of receiving 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 of receiving the Company's report. 
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(i) Company Determination of Invalid Data. 

(l)Except as described in subparagraph (i)(2), if the Company becomes aware that 

circumstances clearly beyond the control of the Company or laboratory will prevent, or have 

prevented, development of scientifically valid data under the conditions specified in paragraphs (c) 

and (e), the Company remains prohibited from further manufacture and import of the PMN 

substance beyond the applicable production limit. 

(2) The Company may submit to EPA, within 2 weeks of first becoming aware of such 

circumstances, a written statement explaining why circumstances clearly beyond the control ofthe 

Company or laboratory will cause or have caused development of scientifically invalid data. EPA 

will notifY the Company of its response, in writing, within 4 weeks of receiving the Company's 

report. EPA's written response may either: 

(i) allow the Company to continue to manufacture and import the PMN substance 

beyond the applicable production limit, or 

(ii) require the Company to continue to conduct, or to reconduct, the study in 

compliance with paragraphs (b), (c), and (e)(l) and (2). If there is sufficient time to conduct or 

reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding the 

production limit as required by subparagraph (e )(3), the Company shall comply with subparagraph 

(e)(3). If there is insufficient time for the Company to comply with subparagraph (e)(3), the 

Company may exceed the production limit and shall submit the report and data in triplicate to EPA 

within a reasonable period of time, all as specified by EPA in the notice described in subparagraph 

(i)(2). EPA will respond to the Company, in writing, within 6 weeks of receiving the Company's 

report and data, as to whether the Company may continue to manufacture and import beyond the 

applicable production limit. 
10 

0) Unreasonable Risk. 

(l) EPA may notify the Company in writing that EPA finds that the data generated by a 

study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, the 

PMN substance will or may present an unreasonable risk of injury 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 of the PMN 

substance to mitigate exposures to or to better characterize the risks presented by the PMN 

substance. Within 2 weeks from receipt of such 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 of the notice described in subparagraph O)(l), the 

Company complies with such requirements as EPA's notice specifies; or 

(3) within 4 weeks from receipt of the notice described in subparagraph 0)( I), 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 of the PMN substance in accordance with the terms of 

this Order pending EPA's response to the Company's written report. EPA will respond to the 

Company, in writing, within 4 weeks of receiving the Company's report. Within 2 weeks of 

receipt of EPA's written response, the Company shall comply with any requirements imposed by 

EPA's response or cease all manufacture, import, processing, distribution, use and disposal of the 

PMN substance. 
11 

(k) Other Requirements. Regardless of the satisfaction of any other conditions in this Testing 

section, the Company must continue to obey all the terms of this 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 of this Consent Order pursuant to Part 

VI of this Consent Order. 

PROTECTION IN THE WORKPLACE 

(a) Establishment of Program. During manufacturing, processing, and use ofthe PMN substance 

at any site controlled by the Company (including any associated packaging and storage and during 

any cleaning or maintenance of equipment associated with the PMN substance), the Company 

must establish a program whereby: 

(I) General Dermal Protection. Each person who is reasonably likely to be dermally 

exposed in the work area to the PMN substance through direct handling ofthe substance or 

through contact with equipment on whlch the substance may exist, or because the substance 

become airborne in a form listed in subparagraph (a)(5) of this section, is provided with, and is 

required to wear, personal protective equipment that provides a barrier to prevent dermal exposure 

to the substance in the specific work area where the substance are selected for use. Each such item 

of personal 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) Suecific Dermal Protective Eguiument. The dermal personal protective equipment 

required by subparagraph (a)(I) of this 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 of Imperviousness. The Company is able to demonstrate that each 

item of chemical protective clothing selected, including gloves, provides an impervious barrier to 

prevent dermal exposure during normal and expected duration and conditions of exposure within 

the work area by anyone or a combination of the following: 

(i) Permeation Testing. Testing the material used to make the chemical protective 

clothing and the construction of the clothing to establish that the protective clothing will be 

impervious for the expected duration and conditions of exposure. The testing must subject the 

chemical protective clothing to the expected conditions of exposure, including the likely 

combinations of chemical substance to which the clothing may be exposed in the work area. 

Permeation testing shall be conducted according to the American Society for Testing and Materials 

("ASTM") F739 "Standard Test Method for Resistance of Protective Clothing materials to 

Permeation by Liquids or Gases." Results shall be recorded as a cumulative permeation rate as a 

function of time, and shall be documented in accordance with ASTM F739 using the format 

specified in ASTM Fl194-89 "Guide for Documenting the Results of Chemical 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 of each work shift during which they are 

exposed to the PMN substance. 

(ii) Manufacturer's Specifications. Evaluating the specifications from the 

manufacturer or supplier of the chemical protective clothing, or of the material used in 

construction of the 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 work 
13 

area. 

(4) Respiratory Protection. Each person who is reasonably likely to be exposed by 

inhalation in the work area to the PMN substance in the form listed in subparagraph (a)(5) ofthis 

section, is provided with, and is required to wear, at a minimum, a NIOSH-certified respirator from 

the respirators listed in subparagraph (a)(6) of this 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 of airborne chemical substance are listed 

for subparagraphs (a)(l) and (4) of this section: 

(i) Particulate (including solids or liquid droplets). 

(6) Authorized Respirators. The following NIOSH~certified respirators 

meet the minimum requirements for subparagraph (a)(4) of this 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 

of the PMN substance by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)(l) shall expire 75 days after promulgation ofa 

final significant new use rule ("SNUR") governing the PMN substance under section 5(a)(2) of 

TSCA unless the Company is notified on or before that day of an action in a Federal Court seeking 

judicial review of the SNUR. If the Company is so notified, subparagraph (a)(l) shall not expire 
14 

until EPA notifies the Company in writing that all Federal Court actions involving the SNUR have 

been resolved and the validity of the SNUR affirmed. 

(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and 

subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Company shall notify each 

person whom it causes, encourages or suggests to manufacture or import the PMN substance of the 

existence of the SNUR. 

(b) Prohibited Uses. The Company shall not manufacture the PMN substance in the United 

States. 

PROCESSING AND USE 

The Company shall not process or use the PMN substance other than 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 stringent than the requirements below. 

The Company is prohibited from any predictable or purposeful release ofthe PMN substance, or 

any waste stream from processing and use containing the PMN substance, into the waters of the 

United States. 
15 

III. RECORDKEEPING 

(a) Records. The Company shan maintain the 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 of TSCA: 

(1) Exemptions. Records documenting that the PMN substance did in fact qualify for any 

one or more of the exemptions described in Section I, Paragraph (b) ofthis Order. Such records 

must satisfy an the statutory and regulatory recordkeeping requirements applicable to the 

exemption being claimed by the Company. Any amounts or batches of the PMN substance 

eligible for the Export exemption in Section I, Paragraph (b)(2) of this Order, are exempt from an 

the requirements in this Recordkeeping section, if the Company maintains, for 5 years from the 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections 12(a)(I)(B) and 12(b), respectively. Any amounts or batches of the PMN substance 

eligible for the Research and Development exemption in Section I, Paragraph (b)(3) of this Order, 

are exempt from an the requirements in this Recordkeeping section, if the Company maintains, for 

5 years from the date oftheir creation, the records required by 40 CFR nO.78(b). For any 

amounts or batches ofthe PMN 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 in paragraphs (2) and (3) below, 

but is exempt from the other recordkeeping requirements in this Recordkeeping section; 

(2) Records documenting the manufacture and importation volume of the PMN substance 

and the corresponding dates of manufacture and import; 

(3) Records documenting the names and addresses (including shipment destination 

address, if different) of all persons outside the site of manufacture or import to whom the Company 
16 

directly sells or transfers the PMN substance, the date of each sale or transfer, and the quantity of 

the substance sold or transferred on such date; 

(4) Records documenting the addresses of all sites of manufacture, import, processing, and 

use; 

(5) Records documenting establishment and implementation of a program for the use of 

any applicable personal protective equipment required pursuant to the Protection in the Workplace 

section of this Order; 

(6) Records documenting the determinations required by the Protection in the Workplace 

section of this Order that chemical protective clothing is impervious to the PMN substance; 

(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 distributees' written agreement to comply with the Distribution section of this 

Order; 

(8) Records documenting compliance with the Release to Water provisions; 

(9) Copies of any Transfer Documents and notices required by the Successor Liability 

section ofthis Order, if applicable; and 

(10) The Company shall keep a copy of this Order at each of its sites where the PMN 

substance are manufactured of imported. 

(a) Applicabilitv. The provisions of this Recordkeeping Section are applicable only to activities 

of the Company and its Contract Manufacturer, if applicable, and not to activities of the 

Company's customers. 
17 

(b) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of 

information" unless this Order displays a 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 of Company facilities and conveyances 

associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the 

Company in advance to request information pertinent to the scheduling and conduct of such 

inspections. Such requests may be written or oral. The types of information that EPA may request 

may include, but are not limited to, the following: 

(i) Expected dates and times when the PMN substance will be in production within the 

subsequent 12 months; 

(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) Current job titles or categories for workers who are involved in activities associated 

with the PMN substance and may reasonably 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 of this Order; and/or 
18 

(vi) Any other information reasonably related to determining compliance with this Order or 

conducting an inspection for that purpose. 

(b) Company's Response. The Company shall respond to such requests within a reasonable period 

of time, but in no event later than 30 days after receiving EPA's request. When requested in 

writing by EPA, the Company's response shall be in writing. To the extent the information is 

known to or reasonably ascertainable 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 of EPA's requests. 

(c) Confidential Business Information. Any Confidential Business Information ("CBI") that the 

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of 

TSCA and 40 CFR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope. This section sets forth the procedures by which the Company's rights and obligations 

under this Order may be transferred when the Company transfers its interests in the PMN 

substance, including the right to manufacture the PMN substance, to another person outside the 

Company (the "Successor in Interest"). 

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). 

(1) Before NOC. If the transfer from the Company to the Successor in Interest is effective 

before EPA receives a notice of commencement of manufacture or import ("NOC") for the PMN 
19 

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) of TSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective 

after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and 

shall not be required to submit new PMN s to EPA. 

(c) Definitions. The following definitions apply to this Successor Liability section of the Order: 

(I) "Successor in Interest" means a person outside the Company who has acquired the 

Company's full interest in the rights to manufacture the PMN substance, including all ownership 

rights and legal liabilities, through a transfer document signed by the Company, as transferor, and 

the Successor in Interest, as transferee. The term excludes persons who acquire less than the full 

interest ofthe Company in the 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 in the 

PMN substance, including the right to manufacture the PMN substance, from the Company to the 

Successor in Interest. 

(d) Notices. 

(I) Notice to Successor in Interest. On or before the effective date of the transfer, the 

Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent 
20 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment C 

to this Order. 

(2) Notice to EPA. Within 10 business days ofthe effective date of the transfer, the 

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: 

U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania 

Avenue, N.W., Washington, D.C. 20460. 

(3) Transfer Document. Copies ofthe Transfer Document must be maintained by the 

Successor in Interest at its principal place of business, and at all sites where the PMN substance are 

manufactured or imported. Copies ofthe Transfer Document must also be made available for 

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability for the PMN substance under the terms of this 

Order from the Company to the Successor in Interest. 

(e) Liability. 

(1) The Company shall be liable for compliance with the requirements of this Order until 

the effective date of the transfer described above. 

(2) The Successor in Interest shall be liable for compliance with the requirements of this 

Order effective as ofthe date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made, during the time in which the Company manufactured, processed, used, distributed 

in commerce, or disposed of the PMN substance pursuant to the terms ofthis Consent Order. 
21 

(f) Obligations to Submit Test Data under Consent Order. Ifparagraph (d) of the Testing section 

of this Consent Order requires the Company to submit test data to EPA at a specified production 

volume ("test trigger"), the aggregate volume of the PMN substance manufactured and imported 

by the Company up to the date of transfer shall count towards the test trigger 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 or revoke substantive provisions 

of this Order. The exposures and risks identified by EPA during its review of the 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 of the test data or other information 

that supports the findings in this Order, an examination of new test data or other information or 

analysis, and any other relevant information. 

EPA will issue a modification or revocation if EPA determines that the activities proposed 

therein will not present an unreasonable risk of injury to health or the environment and will not 

result in significant or substantial human exposure or substantial environmental release in the 

absence of data sufficient to permit a reasoned evaluation of the health or environmental 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 if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 
23 

By consenting to the entry of this Order, the Company waives its rights to file objections to 

this Order pursuant to section 5(e)(1)(C) ofTSCA, to receive service ofthis Order no later than 45 

days before the end of the review period pursuant to section 5(e)(1)(B) ofTSCA, and to challenge 

the validity of this Order in any subsequent action. Consenting to the entry of this Order, and 

agreeing tobe bound by its tenus, do not constitute an admission by the Company as to, the facts 

or conclusions underlying the Agency's determinations in this proceeding. This waiver does not 

affect any other rights that the Company may have under TSCA. 

By signing this Order, the Company represents that it has carefully reviewed this document 

and hereby agrees that all information herein that is claimed as confidential by the Company (per 

section 14 of TSCA, 40 CFR Part 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. 

fof,~ /10 

Date' 

Date! 7 Name: ;David Waller 

Title: Director of Materials and Chemistry 

Company: Konarka Technologies, Inc. 
ATTACHMENT A 

DEFINITIONS 

[Note: The attached Order may not contain some of the terms defined below.] 

"Chemical name" means the scientific designation of a chemical substance in accordance 

with the nomenclature system developed by the International Union of Pure and Applied 

Chemistry or the Chemical Abstracts Service's rules of nomenclature, or a name which will clearly 

identify a chemical substance for the purpose of conducting a hazard evaluation. 

"Chemical protective clothing" means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substance of concern. 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 of a 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 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 of a mixture, 

sold or made available to consumers for their use in or around a permanent or temporary 

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, 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. of this 

Consent Order and in the Consent Order for Contract Manufacturer. 

"Identity" means any chemical or common name used to identify a chemical substance or 

a mixture containing that substance. 

"Immediate use." A chemical substance is for the "immediate use" of a person if it is under 
2 

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 if the 

substance causes no chemical or mechanical degradation, permeation, or penetration of the 

chemical protective clothing under the conditions of, and the duration of, exposure. 

"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a 

chemical substance, regardless of physical state or concentration, through all intended operations 

of manufacture, including the cleaning of equipment. 

"MSDS" means material safety data sheet, the written listing of data for the chemical 

substance. 

"NIOSH" means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health 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 of the 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, or processed. 

"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 in this definition. 

"Process stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

processing, including the cleaning of equipment. 

"Scientifically invalid" means any significant departure from the EPA-approved protocol 

or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

approval that prevents a reasoned evaluation of the health or environmental effects ofthe PMN 

substance. 

"Scientifically equivocal data" means data which, although developed in apparent 
3 

confonnity with the Good Laboratory Practice Standards and EPA-approved protocols, are 

inconclusive, internally inconsistent, or otherwise insufficient to pennit a reasoned evaluation of 

the potential risk of injury to human health or the environment of the PMN substance. 

"Sealed container" means a closed container that is physically and chemically suitable for 

long-tenn containment of the 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 of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

industrial, commercial, or consumer use. 

"Waters of the 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 SUBSTANCE CONTROL ACT 

SECTION See) CONSENT ORDER 

PMNNumber 

I. Transfer of Manufacture Rights. Effective on , the Company did sell or 

otherwise transfer to , ("Successor in Interest") the rights 

and liabilities associated with manufacture of the above-referenced chemical substance, which was 

the subject of a 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) of the Toxic 

Substance Control Act (TSCA, 15 U.S.c. §2604(e». 

2. Assumption of Liability. 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 of the PMN substance, shall 

be the responsibility of the Successor in Interest. Successor in 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 of TSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or "relinquishes" is 

indicated, that designation shall be deemed to apply to all such claims. Where "modifies" is 

indicated, such modification shall be explained in detail in an attachment to this Notice 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 treatment under this Notice of Transfer. 
2 

TOXIC SUBSTANCE CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Company (Transferor) PMNNumber 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 
3 

TOXIC SUBSTANCE CONTROL ACT 

SECTION See) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone