UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

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Premanufacture Notice Numbers: 

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

Consent Order, Consent Order for Processor, 

and Determinations Supporting Consent Orders 
TABLE OF CONTENTS 

Preamble 

I. Introduction 

II. Summary of Tenns of the Order 

III. Contents of PMN 

IV. EPA's Assessment of Risk 

V. EPA's Conclusions of Law 

VI. Infonnation Required to Evaluate Human Health Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation ofInfonnation 

III. Recordkeeping 

IV. Requests for Pre-Inspection Infonnation 

V. Successor Liability Upon Transfer 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 

Attachment C - Consent Order for Processor 
PREAMBLE 

I. INTRODUCTION 

Under the authority of § 5(e) of the Toxic Substances Control Act ("TSCA") (15 U.S.C. 

2604( e)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached 

Order, regarding premanufacture notices ("PMNs") P-09-142-144 for the following chemical 

substances, 3 'H-Cyclopropa[1,9][5,6]fullerene-C60-Ih-3' -butanoic acid, 3' -phenyl-, methyl ester 

(CAS No: 160848-22-6, P-09-142), 3 'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-

butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 

3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3' -butanoic acid, 3' -phenyl-, methyl ester 

(CAS No. 1051371-21-1, P-09-144) (the "PMN substances") submitted by Nano-C, Inc. ("the 

Company"), to take effect upon expiration of the PMN review period. The Company submitted 

the PMNs to EPA pursuant to section 5(a)(l) ofTSCA and 40 CFR Part 720. 

Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any 

provision of § 5 or any order issued under § 5. Violators may be subject to various penalties and 

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

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

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

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for these PlviN substances requires the Company to: 

(I) Submit to EPA certain health test data and physical/chemical property data before exceeding 

a specified manufacturing and import volume; 
(2) Provide workers with impervious gloves and clothing that covers any other exposed areas of 

the arms, legs, and torso; 

(3) Provide workers with a NIOSH-approved full-face respirator with an N -100 cartridge when 

exposed by inhalation in the work area; 

(4) Use the PMN substances only as: (I) a compound used in fabrication and/or operation of 

electronic devices that enables or improves the conductivity, efficiency, voltage or other 

characteristics of the device; or (2) a compound used to improve the mechanical properties of 

lubricants and plastics; 

(5) Distribute the PMN substances only to a person who agrees to follow the same 

restrictions (except the testing requirements); 

(6) Comply with the Release to Water provisions; and 

(7) Maintain certain records. 

A Consent Order for Processor is attached to extend these requirements to any Processor. 

III. CONTENTS OF PMN 

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

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

Company (per section 14 ofTSCA, 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): 

Impurities, production volume, byproducts, process description, environmental release and 
disposal, and worker/occupational exposure. 

Chemical Identity: modified fullerene C60 - P09-0142, and modified fullerenes C70 - P09-143-

144; 

3 'H-Cyclopropa[1 ,9][5,6]fullerene-C60-Ih-3' -butanoic acid, 3 ' -phenyl-, methyl ester 

(CAS No: 160848-22-6, P-09-142), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-

butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 

3'H-Cyclopropa[7,22] [5,6]fullerene-C70-D5h(6)-3' -butanoic acid, 3' -phenyl-, methyl ester 

(CAS No. 1051371-21-1, P-09-144). 

Use: 

(I) a compound used in fabrication and/or operation of electronic devices that enables or 

improves the conductivity, efficiency, voltage or other characteristics ofthe device; or (2) 

a compound used to improve the mechanical properties of lubricants and plastics; 

Maximum 12-Month Production Volume: P-09-142 - [ ] kg/yr, P-09-143-144 - [ ] kg/yr. 

Test Data Submitted with PMN: Particle size distribution. 

IV. EPA'S ASSESSMENT OF RISK 

The following are EPA's predictions regarding the probable toxicity, human exposure 

and environmental release of the PMN substances, 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 ofless 

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

lung inflammation and systemic effects, including immunotoxicity, if inhaled. The PMN 

substances may induce gene mutation in bacterial cells and in manunalian cells in culture and in 

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

manunalian cells in culture and in vivo. There is concern that the PMN substances may 

disperse/disaggregate 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 nanoparticles appear to have immunotoxicity hazard 

potential. Pulmonary exposure to these PMN substances may lead to toxicity to alveolar 

macrophage, impaired clearance of inhaled bacteria and possible systemic immunosuppression. 

Occupational Exposure 

TABLE I - P09-142 

Scenario # Sites # Workers Inhal (mg/d) Derm (mg/d) 

Manufacturing [ 1 [ 1 0.64 (particle) 3100 (solid) 

Processing [ 1 [ 1 0.0064 (particle) 3100 (solid) 

18 (liquid) 

Use [ 1 [ 1 negligible 87 (liquid) 
TABLE 2 - P09-l43/144 

Scenario # Sites # Workers Inhal (mg/ d) Derm(mg/d) 

Manufacturing [ 1 [ 1 0.32 (particle) 3100 (solid) 

Processing [ 1 [ 1 0.032 (particle) 3100 (solid) 

18 (liquid) 

Use [ 1 [ 1 negligible 87 (liquid) 

Risk to Workers: A comparison of Tables 1 and 2 above indicates a greater predicted inhalation 

exposure value (0.64 mg/day) during manufacturing for P09-l42. Therefore, since P09-

142/143/144 are close analogues, the inhalation exposure value of 0.64 mg/day (0.064 mg/m3) 

and the NCEL (New Chemical Exposure Limit) of 0.05 mg/m3 for crystalline silica was used for 

EPA's risk assessment calculations. Therefore, the predicted worst case worker inhalation 

exposure of 0.064 mg/m3 for P09-l42 during manufacturing, when compared to the NCEL of 

0.05 mg/m3 for crystalline silica, poses a potential carcinogenic risk to workers exposed via 

inhalation. 

Risk to General Public: A qualitative evaluation of estimated releases indicates a low potential 

risk to the general population from exposure to the PMN substances via water, landfill, and/or 

incineration releases. 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis ofthe Consent Order: 

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

substances. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) ofTSCA, that the information 

available to the Agency is insufficient to permit a reasoned evaluation ofthe human health 

effects of the PMN substances. 
(b) In light of the potential risk to hnrnan health posed by the uncontrolled manufacture, import, 

processing, distribution in commerce, use, and disposal of the PMN substances, EPA has 

concluded, pursuant to § 5(e)(1)(A)(ii)(I) ofTSCA, that uncontrolled manufacture, import, 

processing, distribution in commerce, use, and disposal ofthe PMN substances may present an 

unreasonable risk of injury to hnrnan health. 

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS 

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

production volnrne or time period unless the Company submits the information described in the 

Testing section ofthis Order in accordance with the conditions specified in the Testing section. 
CONSENT ORDER 

SCOPE OF APPLICABILITY AND EXEMPTIONS 

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

distribution in commerce, use and disposal of the following chemical substances, 3'HCyclopropa[l ,9][5,6]fullerene-C60-Ih-3' -butanoic acid, 3' -phenyl-, methyl ester 

(CAS No: 160848-22-6, P-09-142), 3'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-

butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 

3 'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3' -butanoic acid, 3' -phenyl-, methyl ester 

(CAS No. 1051371-21-1, P-09-144) (the "PMN substances"), in the United States by Nano-C, 

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 substances 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 (1) these activities are conducted in full compliance with all applicable requirements 

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

recordkeeping as required in the Recordkeeping section of this Order. 

(I) Mitigated States of the PMN Substances The requirements of this Order do 

not apply to quantities of the PMN substances that have been (i) completely reacted (cured); (ii) 
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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 

120.3(c). 

(2) Export. Until the Company begins commercial manufacture of the PMN substances 

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

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

with TSCA §12(a) and (b), 40 CFR 120.3(s) and 40 CFR Part 707. However, once the Company 

begins to manufacture the PMN substances for use in the United States, no further activities by 

the Company involving the PMN substances are exempt as "solely for export" even if some 

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

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

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

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 substances in 

small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 

120.3(cc), and 40 CFR 120.36. 

(4) Byproducts. The requirements of this Order do not apply to the PMN substances 

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

40 CFR 120.3(d) and in compliance with 40 CFR 120.30(g). 
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(5) No Separate Commercial Purpose. The requirements of this Order do not apply to 

the PMN substances when they are manufactured, processed, distributed in commerce, used 

and/or disposed pursuant to any of the exemptions in 40 CFR 720.30(h), with no commercial 

purpose separate from the substances, mixture, or article of which they are a part. 

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

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

("LVE") or Low Release and Exposure Exemption ("LoREx") under TSCA §5(h)(4) and 40 

CFR 723 .s0( c)(1) and (2) respectively, any such exemption is automatically rendered null and 

void as of the 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 of the PMN substances in the United States, for any nonexempt 

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

evaluation of the human health effects of the substances, 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. 
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TESTING 

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

the conclusion that the PMN substances 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 substances and shall contain a statement that the substances are subject to this Consent 

Order. Additional information regarding section 8( e) reporting requirements can be found in the 

reporting guide referenced at 56 Federal Register 28458 (June 20,1991). 

(b) Notice 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 15 days after the effective date of this Order, whichever is later~ 

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

(2) The name and address of the laboratory which wilI 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 substances and a statement that 

the substances are subject to this Consent Order. 
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(c) Good Laboratory Practice Standards and Test Protocols. Each study required to be 

perfonned 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 oftest protocols, including selection of the test 

substances, 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 oftest protocols, but are not themselves acceptable 

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

(d) Triggered Testing Requirements. 

(1) 90-day inhalation toxicity test. The Company is prohibited from manufacturing or 

importing the PMN substances beyond the following aggregate manufacture and import volume 

of all three PMN substances combined ("the production limit"), unless the Company conducts 

the following test on one of the PMN substances (selected by the Company and approved by 

EPA) and submits all final reports and underlying data in accordance with the conditions 

specified in this Testing section. 

Production Limit 

[ 1 kg 

Test Guideline 

90-day inhalation toxicity study 

on rats with a post-exposure OCSPP 870.3465 

observation period of up to 3 months, or OECD 413 

including bronchoalveolar lavage fluid 

("BALF") analysis, a detennination 

of cardiovascular toxicity (clinically-based 

blood/plasma protein analyses), and 

histopathology of the heart along with 

data on pulmonary deposition, 
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clearance half-life (biopersistence) 

and translocation of the test material and 

particle size distributions prior to, and 

during, the inhalation tests. 

Physical/chemical properties. The Company is prohibited from manufacturing or 

importing, or causing another person to manufacture or import, any of the PMN substances 

beyond 9 months after the first date of commencement of nonexempt commercial 

manufacture or import of anyone of the PMN substances ("the production limit"), unless the 

Company provides the following data for each of the PMN substances and submits all final 

reports and underlying data in accordance with the conditions specified in this Testing 

section: 

Water solubility (OECD 105 test method); 

Surface chemistry: EELS (electron energy loss spectroscopy) and/or XPS (ESCA) (X-ray 

photoelectron spectroscopy/electron spectroscopy for chemical analysis), functionalized 

probe AFM (atomic force microscopy), or Auger electron spectroscopy; 

Dry particle size distribution by count for each PMN substance in a form which has the 

highest content of particles smaller than 10 microns as manufactured, processed or used 

in the workplace at sites controlled by the Company. The method shall be STEM 

(scanning transmission electron microscopy), using a dry particle counting method, with a 

resolution of < I nanometer and with no counting after dispersion in a solution and 

evaporating solvent); and 

- Dustiness test (EN 15051 method) 

Description ofthe physical-chemical properties of the material tested should take into 

consideration the characterizations identified in the most recent version ofthe Guidance Manual 

for the Testing of Manufactured Nanomaterials: OECD's Sponsorship Programme. 

(e) Test Reports. The Company shall: (I) conduct each study in good faith, with due care, and 

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

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

ofthis 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 substances 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 necessary to permit a reasoned evaluation ofthe risks presented by the PMN 

substallces, only by mutual consent of EPA and t.he Company. 

(h) EPA Determination of Invalid Data. 
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(I) Except as described in subparagraph (h)(2), if, within 6 weeks of EPA's receipt of a 

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 substances beyond the applicable production limit. 

(2) The Company may continue to manufacture and import the PMN substances 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 oftime, all as specified 

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

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

(ii) The Company may, within 4 weeks of receiving from EPA the notice described 

in subparagraph (h)(l), 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. 

(i) Company Determination ofInvalid Data. 

(1 )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) 
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and (e), the Company remains prohibited from further manufacture and import of the PMN 

substances 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 of the 

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 substances 

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)(1) 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 oftime, all as specified by EPA in the notice described in subparagraph 

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

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

applicable production limit. 

G) Unreasonable Risk. 

(1) 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 
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PMN substances 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 

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

substances. Within 2 weeks from receipt of such a notice, the Company must cease all 

manufacture, import, processing, distribution, use and disposal of the PMN substances, unless 

either: 

(2) within 2 weeks from receipt ofthe notice described in subparagraph 0)(1), the 

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

(3) within 4 weeks from receipt ofthe notice described in subparagraph (j)(1), the 

Company submits to EPA a written report refuting EPA's finding and/or the appropriateness of 

any additional requirements imposed by EPA. The Company may continue to manufacture, 

import, process, distribute, use and dispose of the PMN substances 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 shaH comply with any requirements imposed by 

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

PMN substances. 

(k) Other Reguirements. Regardless of the satisfaction of any 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 of this Consent Order pursuant to Part 
11 

VI ofthis Consent Order. 

PROTECTION IN THE WORKPLACE 

(a) Establishment of Program. During manufacturing, processing, and use of the PMN substances 

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 substances), the Company 

must establish a program whereby: 

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

exposed in the work area to the PMN substances through direct handling of the substances or 

through contact with equipment on which the substances may exist, or because the substances 

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 substances in the specific work area where the substances 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) Specific Dermal Protective Equipment. The dermal personal protective equipment 

required by subparagraph (a)(I) of this section must include, but is not limited to, the following 

items: 

(i) Gloves impervious to the PMN substances 

(ii) Clothing that covers any other exposed areas of the arms, legs, and torso. 

(3) Demonstration ofImperviousness. 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 
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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 substances 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 oftime, and shall be documented in accordance with ASTM F739 using the format 

specified in ASTM F1194-89 "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 substances. 

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

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

construction ofthe clothing, to establish that the chemical protective clothing will be impervious to 

the PMN substances alone and in likely combination with other chemical substances in the work 

area. 

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

inImlation in the work area to t.~e PMN Substa.l1ces in the form listed in subparagraph (a)(5) of this 

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 
13 

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 substances 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 substances by any other person. 

(2) Sunset Following SNVR. Subparagraph (a)(I) shall expire 75 days after promulgation of a 

final significant new use rule ("SNUR") governing the PMN substances 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 ofthe SNUR. If the Company is so notified, subparagraph (a)(l) shall not expire 

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

been resolved and the validity of the SNUR affirmed. 

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

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

person whom it causes, encourages or suggests to manufacture or import the PMN substances of 
14 

the existence of the SNUR. 

(b) Prohibited Uses. The Company shall not manufacture or import the PMN substances for 

use other than as: (1) a compound used in fabrication and/or operation of electronic devices that 

enables or improves the conductivity, efficiency, voltage or other characteristics of the device; 

or (2) a compound used to improve the mechanical properties of lubricants and plastics. 

The Company shall not mix or manufacture the PMN substance to encapsulate another chemical 

substance. 

PROCESSING AND USE 

The Company shall not process or use the PMN substances other than as: (1) a compound used 

in fabrication and/or operation of electronic devices that enables or improves the conductivity, 

efficiency, voltage or other characteristics ofthe device; or (2) a compound used to improve the 

mechanical properties of lubricants and plastics. The Company shall not mix, process or use the 

PMN substances to encapsulate another chemical substance. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Company shall notifY in 

writing any person to whom it distributes the PMN substances (a Distributee) that, due to the 

issuance of this Consent Order under section 5( e) ofTSCA, the PMN substances are subject to the 

export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such 

notice shall contain, in the form in which they appear in the Consent Order, the following 

information: (1) the PMN numbers and (2) either (A) the specific chemical identities of the 
15 

chemical substances, or (B) if the specific chemical identities are confidential, the generic 

chemical identities. 

(b) Types of Distributees. This Distribution section authorizes the Company to distribute 

the PMN substances to three types of Distributees: (1) Distributees who will further distribute the 

PMN substances only when the PMN substances are in a mitigated state, as defined in paragraph 

(c); (2) Distributees who will further distribute the PMN substances in an unmitigated state before 

the attached Consent Order for Processor expires 75 days after promulgation of a final SNUR 

governing all of the PMN substances; and (3) Distributees who will further distribute the PMN 

substances in an unmitigated state after the attached Consent Order for Processor expires 75 days 

after promulgation of a final SNUR governing all of the PMN substances. The distribution 

requirements for the first and third type of Distributee are identical and are stated in paragraph (e) 

below. The second type of Distributee must sign the attached Consent Order for Processor, as 

specified in paragraph (f) below. 

(c) Mitigated States ofthe PMN Substances. For purposes of further distribution, the PMN 

substances shall be considered to be in a "mitigated state" (regarding risk) when the PMN 

substances 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 nO.3(c). 
16 

(d) Temporary Transport and Storage. Notwithstanding paragraphs (e) and (t) in this 

Distribution section, the Company may distribute the PMN substances outside the Company for 

temporary transport and storage in sealed containers provided the following two conditions are 

met: 

(l) Subsequent to any such exempt temporary transport or storage of sealed containers, the 

PMN substances may be distributed only to the Company or to a Distributee compliant with 

paragraph (e) or (t). 

(2) Any human exposure or environmental release resulting from opening the sealed 

containers and removing or washing out the PMN substances may occur only while the PMN 

substances are in the possession and control of the Company or a Distributee compliant with 

paragraph (e) or (t). 

(e) Distribution Requirements in the Absence of Processor Order. Except when the PMN 

substances are in a mitigated state as described in paragraph (c) above, or as provided in the 

Temporary Transport and Storage paragraph (d) above, or for Distributees who sign Processor 

Orders as described in paragraph (t) below, the Company shall distribute the PMN substance 

outside the Company, other than for disposal, only to a Distributee who has agreed in writing prior 

to the date of distribution, to: 

(1) Notify in writing any person to whom it distributes the PMN substance that, due to the 

issuance of this Consent Order under section See) of TSCA, the PMN substance is subject to the 

export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such 

notice shall contain, in the form in which it appears in this Consent Order, the following 

information: (l) the PMN number, and (2) either (A) the specific chemical identity ofthe PMN 
17 

substance, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(2) Not further distribute the PMN substances to any other person, other than for disposal, 

except when the PMN substances are in a mitigated state, as described in paragraph (c) above. 

(3) Comply with the same requirements and restrictions required of the Company in the 

Protection in the Workplace section; 

(4) Comply with the same requirements and restrictions required of the Company in the 

Release to Water section ofthis Order; and 

(5) Not process or use the PMN substances other than as: (l) a compound used in 

fabrication and/or operation of electronic devices that enables or improves the conductivity, 

efficiency, voltage or other characteristics of the device; or (2) a compound used to improve the 

mechanical properties oflubricants and plastics; 

(6) Not mix, process, or use the PMN substance to encapsulate another chemical 

substance. 

(f) Consent Order for Processor. 

(1) If the Company distributes the PMN substances to Distributees who will further 

distribute the PMN substances in an unmitigated state, before the attached Consent Order for 

Processor expires 75 days after promulgation of a final SNUR governing all of the PMN 

substances, the Company shall distribute the PMN substances outside the Company, other than for 

disposal, only to a Distributee who has signed the Consent Order for Processor in Attachment C to 

this Order (a "Processor"). 

(2) The Company shall obtain from each such Processor a signed copy of the Consent 

Order for Processor and submit the copy to EPA along with the name, address, and telephone 
18 

number of a responsible official of the Processor. The Processor or Company must receive a fully 

executed copy of the Consent Order for Processor from EPA before the Processor may begin to 

process any of the PMN substances. 

(g) Sunset following SNUR. 

(1) If the Company distributes the PMN substances to Distributees who will further 

distribute the PMN substances in an unmitigated state, before the attached Consent Order for 

Processor expires 75 days after promulgation of a final SNUR governing all of the PMN 

substances, the Company shall distribute the PMN substances, other than for disposal, only to 

processors who have signed the attached Consent Order for Processor in accordance with 

paragraph (f) of this Distribution section. After the attached Consent Order for Processor expires 

75 days after promulgation of a fmal SNUR governing all of the PMN substances, the Company 

shall distribute the PMN substances only to Distributees who comply with the requirements 

specified in paragraph (e) of this Distribution section. 

(2) Paragraphs (e)(2) and (f) ofthis Distribution section shall expire 75 days after 

promulgation of a final SNUR for the PMN substances under section 5(a)(2) ofTSCA, 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, paragraphs (e)(2) and (f) ofthis Distribution section 

shall not expire until EPA notifies the Company in writing that all Federal Court actions involving 

the SNUR have been resolved and the validity of the SNUR affirmed. 

(3) When EPA promulgates a final SNUR for the PMN substances and paragraph (e)(2) 

and (f) of this Distribution section expires in accordance with subparagraph (g)(2), the Company 

shall notify each Distributee to whom it distributes the PMN substances of the existence of the 
19 

SNUR. Such notification must be in writing and must specifically include all limitations contained 

in the SNUR which are defined as significant new uses, and which would invoke significant new 

use notification to EPA for the PMN substances. Such notice must also reference the publication 

of the SNUR for these PMN substances in either the Federal Register or the Code of Federal 

Regulations. After promulgation of a SNUR and expiration of paragraphs (e )(2) and (f), such 

notice may substitute for the written agreement required in the introductory clause of paragraph 

(f); so that, if the Company provides such notice to the Distributee, then the Company is not 

required to obtain from such Distributee the written agreement specified in paragraph (e). 

However, even absent such written agreement, the Company remains obligated to comply with the 

"Recipient Non-Compliance" paragraph (h) below. 

(h) Recipient Non-Compliance. If, at any time after commencing distribution in commerce ofthe 

PMN substances, the Company obtains knowledge that a recipient (including a Processor) of the 

PMN substances has failed to comply with any ofthe applicable conditions specified in paragraphs 

(e )(2) or (f) ofthis Distribution section or, after paragraphs (e )(2) or (f) expires in accordance with 

paragraph (g)(2), has engaged in a significant new use of the PMN substances (as defined in 40 

CFR Part 721, Subpart E) without submitting a significant new use notice to EPA, the Company 

shall cease supplying the substances to that recipient, unless the Company is able to document 

each of the following: 

(1) That the Company has, within 5 working days, notified the recipient in writing that the 

recipient has failed to comply with any of the applicable conditions specified in paragraphs (e)(2) 

or (f) ofthis Distribution section, or has engaged in a significant new use of the PMN substances 

without submitting a significant new use notice to EPA. 
20 

(2) That, within 15 working days of notifying the recipient ofthe noncompliance, the 

Company received from the recipient, in writing, a statement of assurance that the recipient is 

aware of the applicable terms of paragraphs (e)(2) or (f) of this Distribution section and will 

comply with those terms, or is aware of the terms of the significant new use rule for the PMN 

substances and will not engage in a significant new use without submitting a significant new use 

notice to EPA. 

(3) If, after receiving a statement of assurance from a recipient under subparagraph (h)(2) 

of this Distribution section, the Company obtains knowledge that the recipient has failed to comply 

with any of the applicable conditions specified in paragraphs (e)(2) or (f) ofthis Distribution 

section, or has engaged in a significant new use ofthe PMN substances without submitting a 

significant new use notice to EPA, the Company shall cease supplying the PMN substances to that 

recipient, shall notify EPA of the failure to comply, and shall resume supplying the PMN 

substances to that recipient only upon written notification from the Agency. 

RELEASE TO WATER 

This provision does not supercede or preempt any applicable federal, state, or local laws and 

regulations. Those may be more stringent than the requirements below. 

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

any waste stream from manufacturing, processing or use containing the PMN substance into the 

waters of the United States. 

III. RECORDKEEPING 

(a) Records. The Company shall maintain the following records until 5 years after the date they 
21 

are created and shall make them available for inspection and copying by EPA in accordance with 

section II of TSCA: 

(1) Exemptions. Records docnmenting that the PMN substances did in fact qualify for any 

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

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

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

eligible for the Export exemption in Section I, Paragraph (b )(2) ofthis Order, are exempt from all 

the requirements in this Recordkeeping section, 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)(l)(B) and 12(b), respectively. Any amounts or batches of the PMN substances 

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

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

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

amounts or batches of the PMN substances claimed to be eligible for any other exemption 

described in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating 

qualification for that exemption as well as the records specified in paragraphs (2) and (3) below, 

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

(2) Records documenting the manufacture and importation volnme ofthe PMN substances 

and the corresponding dates of manufacture and import; 

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

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

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

the substances sold or transferred on such date; 
22 

(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 substances; 

(7) Records documenting compliance with any applicable manufacturing, processing, use, 

and distribution restrictions in the Manufacturing, Processing and Use, and Distribution sections of 

this Order, including any Consent Order for Processors and distributees' written agreement to 

comply with the Distribution section 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 of this Order, if applicable; and 

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

substances are manufactured of imported. 

(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities 

ofthe Company and not to activities of the Company's customers. 

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

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

"collection of information" unless this Order displays a currently valid control number from the 
23 

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 II ofTSCA and 40 CFR 720.122, EPA 

may occasionally conduct on-site compliance inspections of Company facilities and conveyances 

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

the Company in advance to request information pertinent to the scheduling and conduct 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 substances will be in production within the 

subsequent 12 months; 

(ii) Current workshift schedules for workers who are involved in activities associated with 

the PMN substances and may reasonably be exposed to the PMN substances; 

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

with the PMN substances and may reasonably be exposed to the PMN substances; 

(iv) Existing exposure monitoring data for workers who are involved in activities 

associated with the PMN substances and may reasonably be exposed to the PMN substances; 

(v) Records required by the Recordkeeping section of this Order; and/or 

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

conducting an inspection for that purpose. 
24 

(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 of the 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 

substances, including the right to manufacture the PMN substances, 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 

substances 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 substances. 
25 

(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 tenns of this Order and 

shall not be required to submit new PMNs 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 substances, including all ownership 

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

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

interest of the Company in the PMN substances, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substances. A Successor in 

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CFR n0.22(a)(3). 

(2) "Transfer Document" means the legal instrument(s) used to convey the interests in the 

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

the Successor in Interest. 

(d) Notices. 

(1) 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 

Order a.'1d the "Notice of Transfer" document which is incorporated by reference as Attachment C 

to this Order. 

(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the 
26 

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 of the Transfer Document must be maintained by the 

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

are manufactured or imported. Copies of the 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 substances under the terms of 

this Order from the Company to the Successor in Interest. 

(e) Liability. 

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

the effective date ofthe 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 ofthe 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 substances pursuant to the terms of this Consent Order. 

(f) Obligations to '<ubmit 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 substances manufactured and imported 
27 

by the Company up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest. 

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 substances, to modify or revoke substantive provisions 

of this Order. The exposures and risks identified by EPA during its review of the PMN substances 

and the information EPA determined to be necessary to evaluate those exposures and risks are 

described in the preamble to this Order. However, in determining whether to amend 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 ofthe health or environmental effects of 

the PMN substances. 

In addition, the Company may petition EPA at any time to make other modifications to the 

language of this 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. 
28 

VII. EFFECT OF CONSENT ORDER 

(a) Waiver. By consenting to the entry of this Order, the Company waives its rights to file 

objections to this Order pursuant to section 5( e)(l )(C) of TSCA, to receive service of this Order no 

later than 45 days before the end of the review period pursuant to section 5(e)(I)(B) ofTSCA, and 

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

Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to, 

the facts or conclusions underlying the Agency's determinations in this proceeding. 0 This waiver 

does not affect any other rights that the Company may have under TSCA. 

(b) cm Brackets. By signing this Order, the Company represents that it has carefully reviewed 

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

Company (per section 14 ofTSCA, 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 documeiJ.t available for public viewing, EPA will remove only the 

information contained within the brackets. 

lof/~ Lo 

Date or I 

Date Name: ViktorVejl s 

Title: President 

Company: Nano-C, lnc. 
ATTACHMENT A 

DEFINITIONS 

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

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

with the nomenclature system developed by the Chemical Abstracts Service's rules of 

nomenclature, or a name which will clearly identify a chemical substances for the purpose of 

conducting a hazard evaluation. 

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

prevent dermal contact with chemical substances 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 of this 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 labeled 

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 ofthe bulk chemical substance and the workplace air may 

occur. 

"Non-industrial use" means use other than at a facility where chemical substances or 

mixtures are manufactured, imported, 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 

substances in the work area. Examples include, but are not limited to, chemical protective 

clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and 

various types of respirators. Barrier creams are not included in this definition. 

"Process" means the preparation of a chemical substance or mixture, after its manufacture, 

for distribution in commerce (A) in the same form or physical state as, or in a different form or 

physical state from, that in which it was received by the person so preparing such substance or 

mixture, or (B) as part of an article containing the chemical substance or mixture. 

"Processor" means the person or persons subject to the Consent Order for Processor in 

Attachment C. 

"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 
3 

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 of the PMN 

substance. 

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

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

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

the potential risk 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-term 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 SUBSTANCES 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 substances, 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) ofthe Toxic 

Substances Control Act (TSCA, 15 U.S.C. §2604(e)). 

2. Assumption of Liability. The Successor in Interest hereby certifies that, as of the effective date 

of transfer, all actions or omissions governed by the applicable Consent Order limiting 

manufacture, processing, use, distribution in commerce and disposal of the PMN substances, 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 SUBSTANCES 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 SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone 
ATTACHMENT C 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF NEW CHEMICAL SUBSTANCES 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

) 

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Premanufacture Notice Numbers: 

P-09-142-144 

Consent Order for Processor 
11 

TABLE OF CONTENTS 

Consent Order 

1. Scope of Applicability and Exemptions 

II. Tertns of Manufactnre, Import, Processing, Distribution in Commerce, Use, and Disposal 

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Modification and Revocation of Consent Order 

VI. Effect of Consent Order 

Attachment A - Definitions 
CONSENT ORDER 

I. SCOPE, EXEMPTIONS AND TERMINATION 

(a) Scope. The requirements ofthis Order apply to all commercial processing, distribution in 

commerce, use and disposal, in the United States, ofthe following chemical substances, 

3 'H-Cyclopropa[I,9][5,6]fullerene-C60-Ih-3'-butanoic acid, 3 '-phenyl-, methyl ester 

(CAS No: 160848-22-6, P-09-142), 3 'H-Cyclopropa[8,25][5,6]fullerene-C70-D5h(6)-3'-

butanoic acid, 3'-phenyl-, methyl ester (CAS No. 609771-63-3, P-09-143), and 

3'H-Cyclopropa[7,22][5,6]fullerene-C70-D5h(6)-3'-butanoic acid, 3' -phenyl-, methyl ester 

(CAS No. 1051371-21-1, P-09-144) (the "PMN substances") submitted by Nano-C, Inc. ("the 

Company"), and processed by ______ - ("the Processor"), except to the extent that those 

activities are exempted by paragraph (b). This Order is an attachment to a related Order applying 

to the Company, which among other requirements, prohibits the Company from distributing the 

PMN substances, unless they have been (i) completely reacted (cured); (ii) incorporated or 

embedded into a polymer matrix that 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 nO.3(c) other than to those 

persons who have either: 

(I) agreed to and signed this Consent Order for Processor, or 

(2) agreed in writing to comply with similar requirements and restrictions as required of 
2 

the Company in the Company's Consent Order. 

(b) Sunset Following SNUR. The Consent Order for Processor (except the 5-year recordkeeping 

requirements in Section III of this Order) shall expire 75 days after promulgation of a final 

significant new use rule ("SNUR") governing the PMN substances under section 5(a)(2) of TSCA, 

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

judicial review of the SNUR. If the Processor is so notified, the conditions shall not expire until 

EPA notifies the Processor in writing that all Federal Court actions involving the SNUR have been 

resolved and the validity of the SNUR affirmed. 

(c) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal of the 

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

Recordkeeping section) only to the extent that (1) these activities are conducted in full compliance 

with all applicable requirements of the following exemptions, and (2) such compliance is 

documented by appropriate recordkeeping as required in the Recordkeeping section of this Order. 

(1) Mitigated States of the PMN Substances The requirements of this Order do not apply 

to quantities of the PMN substances 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) EXDort. Until the Processor begins commercial processing of the PMN substances for 

use in the United States, the requirements of this Order do not apply to manufacture, processing or 

distribution in commerce of the PMN substances solely for export in accordance with TSCA 
3 

§ l2(a) and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Processor begins to 

process the PMN substances for use in the United States, no further activities by the Processor 

involving the PMN substances are exempt as "solely for export" even if some amounts of the PMN 

substances are later exported. At that point, the requirements of this Order apply to all activities 

associated with the PMN substances while in the territory of the United States. Prior to leaving 

U.S. territory, even those quantities or batches of the PMN substances 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 substances 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 substances when 

they are produced, without separate commercial intent, only as "byproducts" as defined at 40 CFR 

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

(5) No Separate Commercial Purpose. The requirements of this Order do not apply to the 

PMN substances when they are manufactured, processed, distributed in commerce, used andlor 

disposed pursuant to any of the exemptions in 40 CFR 720JO(h), with no commercial purpose 

separate from the substances, mixture, or article of which they are a part. 
4 

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION OF INFORMATION 

PROHIBITION 

The Processor is prohibited from manufacturing, importing, processing, distributing in 

commerce, using, or disposing of the PMN substances in the United States, for any nonexempt 

commercial purpose, pending the development of information necessary fora reasoned evaluation 

of the human health effects ofthe substances, 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. 

TESTING 

(a) Section 8ee) Reporting. Reports of information on the PMN substances which reasonably 

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

environment and which is required to be reported under TSCA section 8( e) shall reference the 

appropriate PMN identification numbers for these substances and shall contain a statement that the 

substances are subject to this Consent Order. Additional information regarding section 8( e) 

reporting requirements can be found at www.epagov/opptltsca8e. 

PROTECTION IN THE WORKPLACE 

(a) Establishment of Program. During processing and use ofthe PMN substances at any site 

controlled by the Processor (including any associated packaging and storage and during any 

cleaning or maintenance of equipment associated with the PMN substances), the Processor must 

establish a program whereby: 
5 

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

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

through contact with equipment on which the substances may exist, or because the substances 

become airborne in a 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 substances in the specific work area where the substances 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) Specific Dermal Protective Equipment. The dermal personal protective equipment 

required by subparagraph (a)(l) ofthis section must include, but is not limited to, the following 

items: 

(i) Gloves impervious to the PMN substances 

(ii) Clothing that covers any other exposed areas of the arms, legs, and torso. 

(3) Demonstration of Imperviousness. The Processor is able to demonstrate that any 

gloves selected provide an impervious barrier to prevent dermal exposure during normal and 

expected duration and conditions 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 substances 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 
6 

("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 F1194-89 "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 substances. 

(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 substances alone and in likely combination with other chemical substances in the work 

area. 

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

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

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

the respirators listed in subparagraph (a)(6) ofthis section, and the respirator is used in 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 substances are 

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

(i) Particulate (including solids or liquid droplets). 
7 

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

meet the minimum requirements for subparagraph (a)(4) of this section: NIOSH-certified airpurifying, tight-fitting full-face respirator equipped with NlOO cartridges. 

MANUFACTURING 

(a)(I) Prohibition. The Processor shall not manufacture the PMN substances, or cause, encourage, 

or suggest the manufacture or import, of the PMN substances by any person other than the 

Company. 

PROCESSING AND USE 

The Processor shall not process or use the PMN substances other than as (1) a compound used in 

fabrication and/or operation of electronic devices that enables or improves the conductivity, 

efficiency, voltage or other characteristics ofthe device; or (2) a compound used to improve the 

mechanical properties of lubricants and plastics. The Processor shall not mix, process or use the 

PMN substances to encapsulate another chemical substance. 

DISTRIBUTION 

(a) Export Notice Requirement. No later than the date of distribution, the Processor shall notify in 

writing any person to whom it distributes the PMN substances that, due to the issuance of this 

Consent Order under section 5( e) of TSCA, the PMN substances are subject to the export 

notification requirements ofTSCA section 12(b) and 40 CPR Part 707 Subpart D. Such notice 

shall contain, in the form in which they appear in the Consent Order, the following information: 

(I) the PMN numbers and (2) either (A) the specific chemical identities of the chemical 
8 

substances, or (B) if the specific chemical identities are confidential, the generic chemical 

identities. 

(b) Mitigated States ofthe PMN Substances. For purposes offurther distribution, the PMN 

substances shall be considered to be in a "mitigated state" (regarding risk) when the PMN 

substances 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 nO.3( c). 

(c) Temporary Transport and Storage. Notwithstanding paragraph (d) in this Distribution section, 

the Processor may distribute the PMN substances outside the Processor for temporary transport 

and storage in sealed containers provided the following two conditions are met: 

(I) Subsequent to any such exempt temporary transport or storage of sealed containers, the 

PMN substances may be distributed only to the Company or to a Distributee compliant with 

paragraph (d). 

(2) Any human exposure or environmental release resulting from opening the sealed 

containers and removing or washing out the PMN substances may occur only while the PMN 

substances are in the possession and control of the Company or a Distributee compliant with 

paragraph (d). 

(d) Distribution Requirements. Except when the PMN substances are in a mitigated state as 

described in paragraph (b) above, or as provided in the Temporary Transport and Storage 
9 

paragraph (c) above, the Processor shall distribute the PMN substances outside the Processor's 

company, other than for disposal, only to the Company or a person ("Distributee") who has agreed 

in writing prior to the date of distribution, to: 

(1) Notify in writing any person to whom it distributes the PMN substance that, due to the 

issuance of this Consent Order under section 5(e) ofTSCA, the PMN substance is subject to the 

export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such 

notice shall contain, in the form in which it appears in this Consent Order, the following 

information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN 

substance, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(2) Not further distribute the PMN substances to any other person, other than for disposal, 

except when the PMN substances are in a mitigated state, as described in paragraph (b) above. 

(3) Comply with the same requirements and restrictions required of the Processor in the 

(4) Comply with the same requirements and restrictions required ofthe Processor in the 

Release to Water section of this Order. 

(5) Not process or use the PMN substances other than as: (1) a compound used in 

fabrication and/or operation of electronic devices that enables or improves the conductivity, 

efficiency, voltage or other characteristics of the device; or (2) a compound used to improve the 

mechanical properties oflubricants and plastics; 

(6) Not mix, process, or use the PMN substance to encapsulate another chemical substance. 

(e) Recipient Non-Compliance. If, at any time after commencing distribution in commerce of the 

PMN substances, the Processor obtains knowledge that a recipient of the substances have failed to 
10 

comply with any of the conditions specified in paragraph (d) of this Distribution section, the 

Processor shall cease supplying the substances to that recipient, unless the Processor is able to 

document each ofthe following: 

(1) That the Processor has, within 5 working days, notified the recipient in writing that the 

recipient has failed to comply with any of the conditions specified in paragraph (d) ofthis 

Distribution section, or has engaged in a significant new use of the PMN substances without 

submitting a significant new use notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, the 

Processor received from the recipient, in writing, a statement of assurance that the recipient is 

aware of the terms of paragraph (d) ofthis Distribution section and will comply with those terms, 

or is aware of the terms of the significant new use rule for the PMN substances and will not engage 

in a significant new use without submitting a significant new use notice to EPA. 

(3) If, after receiving a statement of assurance from a recipient under subparagraph (e )(2) 

of this Distribution section, the Processor obtains knowledge that the recipient has failed to comply 

with any ofthe conditions specified in paragraph (d) of this Distribution section, the Processor 

shall cease supplying the PMN substances to that recipient, shall notify EPA ofthe failure to 

comply, and shall resume supplying the PMN substances to that recipient only upon written 

notification from the Agency. 

RELEASE TO WATER 

This provision does not supercede or preempt any applicable federal, state, or local laws and 

regulations. Those may be more stringent than the requirements below. 
II 

The Processor is prohibited from any predictable or purposeful release of the PMN substance, or 

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

United States. 

III. RECORDKEEPING 

(a) Records. The Processor shall maintain the following records until 5 years after the date they 

are created and shall make them available for inspection and copying by EPA in accordance with 

section 11 ofTSCA: 

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

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

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

exemption being claimed by the Processor. Any amounts or batches of the PMN substances 

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

the requirements in this Recordkeeping section, if the Processor 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)(1)(B) and 12(b), respectively.-Any amounts or batches ofthe PMN substances 

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

are exempt from all the requirements in this Recordkeeping section, if the Processor maintains, for 

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

amounts or batches ofthe PMN substances claimed to be eligible for any other exemption 

described in Section I, Paragraph (b) ofthis Order, the Processor shall keep records demonstrating 

qualification for that exemption as well as the records specified in paragraph (2) below, but is 

exempt from the other recordkeeping requirements in this Recordkeeping section; 
12 

(2) 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 Processor 

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

the substances sold or transferred on such date; 

(3) Records documenting the addresses of all sites of processing and use; 

(4) 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; 

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

section ofthis Order that chemical protective clothing is impervious to the PMN substances; 

(6) Records documenting compliance with any applicable manufacturing, processing, use, 

and distribution restrictions in the Manufacturing, Processing, and Use, and Distribution sections 

ofthis Order, including distributees' written agreement to comply with the Distribution section of 

this Order; 

(7) Records documenting establishment and implementation of procedures that ensure 

compliance with any applicable water discharge limitation in the Release to Water section of this 

Order; and 

(8) The Processor shall keep a copy of this Consent Order for Processor at each of its sites 

where the PMN substances are processed. 

(b) .A pp!icabilitv. The provisions of this Recordkeeping Section are applicable only to activities 

of the Processor, and not to activities of the Processor's customers. 
13 

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

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

information" unless this Order displays a currently valid control number from the Office of 

Management and Budget ("OMB"), and EPA so informs the Processor. The "collection of 

information" required in this TSCA §5(e) Consent Orders has been approved under currently valid 

OMB Control Number 2070-0012. 

IV. REQUESTS 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 Processor facilities and conveyances 

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

the Processor 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 substances will be processed within the 

subsequent 12 months; 

(ii) Current workshift schedules for workers who are involved in activities associated with 

the PMN substances and may reasonably be exposed to the PMN substances; 

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

with the PMN substances and may reasonably be exposed to the PMN substances; 

(iv) Existing exposure monitoring data for workers who are involved in activities 

associated with the PMN substances and may reasonably be exposed to the PMN substances; 

(v) Records required by the Recordkeeping section ofthis Order; and/or 
14 

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

conducting an inspection for that purpose. 

(b) Processor's Response. The Processor 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 Processor's response shall be in writing. To the extent the information is 

known to or reasonably ascertainable to the Processor at the time ofthe request, the Processor's 

response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers 

to all of EPA's requests. 

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

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

TSCA and 40 CFR Part 2. 

V. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The conditions ofthis Order (except the provisions regarding the retention of records 

described in III(a), the Recordkeeping section) shall expire 75 days after promulgation of a final 

significant new use rule ("SNUR") governing the PMN substances under section 5(a)(2) ofTSCA, 

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

judicial review of the SNUR. If the Processor is so notified, the conditions shall not expire until 

EPA notifies the Processor in writing that all Federal Court actions involving the SNUR have been 

resolved and the validity of the SNUR affirmed. 

Prior to the promulgation of the final SNUR, the Processor may petition EPA at any time, 
15 

based upon new infonnation on the health effects of, or human exposure to, the PMN substances, 

to modify or revoke substantive provisions of this Order. The exposures and risks identified by 

EPA during its review of the PMN substances and the infonnation EPA detennined to be 

necessary to evaluate those exposures and risks are described in the preamble to this Order. 

However, in detennining whether to amend or revoke this Order, EPA will consider all relevant 

infonnation available at the time the Agency makes that detennination, including, where 

appropriate, any reassessment of the test data or other infonnation that supports the findings in this 

Order, an examination of new test data or other information or analysis, and any other relevant 

infonnation. 

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

therein will not present an umeasonable 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 pennit a reasoned evaluation of the health or environmental effects of 

the PMN substances. 

In addition, the Processor may petition EPA at any time to make other modifications to the 

language of this 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. 
16 

VI. EFFECT OF CONSENT ORDER 

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

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

days before the end ofthe 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 to be bound by its terms, do not constitute an admission by the Processor as to, the facts 

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

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

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

and hereby agrees that all information herein that is claimed as confidential by the Processor (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. 

Date 

Date 

Jim Willis, Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

Name: 

Title: 

Processor Company: 
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 substances 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 substances 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 substances 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 that submitted the PMNs that are the subject of 

the Company's Consent 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 of this 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. 
2 

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

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 substances 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 

substances in the work area. Examples include, but are not limited to, chemical protective 

clothing, aprons, hoods, chemical goggles, face splash shields, or equivalent eye protection, and 

various types of respirators. Barrier creams are not included in this definition. 

"Process" means the preparation of a chemical substance or mixture, after its manufacture, 

for distribution in commerce (A) in the same form or physical state as, or in a different form or 

physical state from, that in which it was received by the person so preparing such substance or 

mixture, or (B) as part of an article containing the chemical substance or mixture. 

"Processor" means the person or persons subject to this Consent Order for Processor. 

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

substance, regardless of physical state or concentration, through all intended operations of 
3 

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 of the PMN 

substance. 

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

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

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

the potential risk 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-term 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.