-- anosys~ ~ 

233 S. Hillview Drive. Milpitas. CA 95035 

Phone: 408-240-6700; Fax: 408-240-6900 

WVNI.nanosysinc.com 

- CONTAINS NO 

Attn: Jim Alwood 

U.S. Environmental Protection Agency 

EPA East Building 

Room 4133G 

1201 Constitution Avenue NW 

Washington, DC 20004 

May 4, 2015 

Re: PMNs P-15-59/60/104 

Dear Mr. Alwood, 

-··-· ·· ·· ·est 

Pursuant to the Consent Order for the above PMNs, please find a·ttached our countersigned copy of the ) 

Order. In addition, we are also including in this packet the signed version of Attachment C from our 

subcontractor Sigma Aldrich Fine Chemical (SAFC) as well as just for your information, the signed PMN 

Notification Letter Agreement from our customer 3M. We will be submitting our Notice of 

Commencement on-line today as well. 

If you should have any questions or comments, please do not hesitate to contact me at {408) 838 8005. 

Best regards, 

/./~// 1'-jL cs:::_- Jason Hartlove 

President and CEO 

Nanosys, Inc. 

Enroil: jhortlove@nonosysinc.com 

(!< ..... 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

, ... " .. . .,. . "' ............. \ ...... 

~,.; ~ i,· ff<i,Yf't)~ OF A NEW CHEMICAL SUBSTANCE 

I: J PENDING DEVELOPMENT OF .INFORMATION 

In the matter of: 

Nanosys, Inc 

) 

) 

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) 

) 

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) 

) 

) 

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Premanufacture Notice Numbers: 

P-15-59/601104 

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Consent Order, Consent Order for Contract Manufacturer, 

and Determinations Supporting Consent Order 

------·- - -· 
II 

TABLE OF CONTENTS 

Preamble 

I. Introduction 

Il. Swnmary ofTen:ns of the Order 

IJI. Contents ofPMNs 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

II. Terms of Manufacture (defined by statute to include import), :Processing, Distribution in 

Commerce, Use, and Disposal Pending Submission and Evaluation oflnformation 

IIJ. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Notice of Transfer of Consent Order 

Attachment C- Consent Order for Contract Manufacturer 
111 

PREAMBLE 

1. 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 Agcncy"}issues the attached 

Order, regarding premanufacture notices ("PMNs") for the chemical substances P 15-59 -

P15-60-

and P15-104-

("the Pr-.1N substances") submitted by Nanosys, Inc. ("the Company"), to take effect upon 

expiration of the PMN review periods. The Company submitted the Pl'v1Ns to EPA pursuant to § 

5(a)(l) ofTSCA and 40 CFR Part 720. 

Under§ 15 ofTSCA, it is Lmlawful for any person to fail or refuse to comply with any 

provision of§ 5 or any order issued under § 5. Violators may be subj ect to various penalt!es and 

to both criminal and civil liabili ty 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) expot1 notice requirement. 

11. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for the PMN substances requires the Company to: 

(a) submit to EPA certain testing within the time triggers of the testing section of the consent 

order; 

(b) provide personal protective equipment to its workers to prevent dermal exposure; 
IV 

(c) manufacture, process and use P-15-59 only as a down-converter for an optical filter for 

LEDs used in displays and P-15-60 and P-15-1 04 as chemical intermediates~ 

(d) manufacture, process, or use the PMN substances only in a liquid formulation; 

(d) distribute the PMN substances only to a person \Vho agrees to follow the same restrictions . . . 

(except the testing requirements) and to not further distribute the PMN substances unless they 

incorporate the PMN substance into an article(film); 

(e) dispose of the PMN substances only by incineration in a permitted hazardous waste 

incinerator; and 

(f) maintain certain records. 

III. CONTENTS OF PMN 

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

agrees that all information herein that is claimed as confidential by the Company is con ectly 

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): Chemical 

Identity, Production Volume, Manufacturing and Processing Information. 

Chemical Identitv: 

Specific: Pl5-59 -

Pl5-60 · 

Pl S-104 -
v 

Generic: P 15-59 - Cadmium selenide zinc sulfide dodecanoic acid and amine in amino functional 

silicone fluid. 

P15-60 - Cadmium selenide zinc sulfide dodecanoic acid and amine. 

P 15-104 - Alkanoic acid, reaction products with. cadmium selenide and alk~~lamine. 

. . Use: P1 5-59 - A down-converter for an optical filter for LEDs used in displays. 

P 15-60 and P 15-104 - Chemical intermediates. 

Maximw11 12-Month Production Volume: Pl5-59-

P15-60-

p 15-104-

Test Data Submitted with PMN: Physical-Chemical Properties. EPA Toxicity Characteristic 

Leaching Procedme (TCLP), California Soluble Threshold Limit Concentration (STLC), 

California Total Threshold Limit Concentration (ITLC), and wipe surface sampling for the 

article (film) containing P-15-59. 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

The following are EPA's predictions regarding the probable human and environmental 

toxicity, human exposure and environmental release of the PMN substances, based on the 

information currently available to the Agency. 

Human llealth Effects Summary: 

Toxicological Endpoints of Concern: EPA identified concerns for lung effects, kidney effects, 

and oncogenicity based on analogy to respirable poorly soluble particulates (See 

ww\v.epa.gov/opptintr/newchems/pubs/chemcat.htm) and the pres.ence of cadmium. 
VI 

Environmental Effects Summary: 

. . 

Organisms exposed to cadmium in the environment may also develop chronic effects from 

exposure to cadmium. 

Exposure and Environmental Release Summruy: 

Manufacture Use 

#Sites 1 . 1 

Workers 6 3 

(#/site) 

Exposure( days/year) 255 250 

Dermal Exposure 6.7E+l 6.7E+l 

(mg/day) 

Inhalation Exposw-e Negligible Negligible 

(mg/day) 

Releases Via incineration Via incineration 

(days/year) 255 250 

Risk to Workers and the environment: There is a potential risk to workers that are exposed to the 

PMN substances. Uncontrolled releases to the environment could also result in risks to humans 

and other organisms. 

V. EPA'S CONCLUS O~S OF LA \.Y 
vii 

The following findings constitute the basis of the Consent Order: 

(a) EPA is unable to determine the potential for human health effects and environmental effects 

from exposure ofhumans and other organisms to the PMN substances. EPA therefore 

concludes, pursuant to § S(e)(J )(A)(i) ofTSCA, that the information available to the Agency is 

insufficient to permit a reasoned evaluation of the hwnan health and environmental effects of the 

PMN substances. 

(b) In light of the potential risk to humans and other organisms posed by the uncontrolled 

manufacture, processing, distribution in conm1erce, use, and disposal ofthe PMN substances, 

EPA has concluded;·pursuant to§ 5(e)(l)(A)(ii)(l) ofTSCA, that uncontralled manufacture, 

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

unreasonable risk of injury to human health and the environment. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH AND 

ENVIRONMENTAL EFFECTS . 

Triggered Testing. The Order requires the Company to submit the information described 

in the Testing section of this Order in accordru1ce with the conditions specified in the Testing 

section. 

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

effects which may be caused by the PMN substances: 

Information 

Metabolism and 

Pharmacokinetics 

Effects 

Toxicokinctic 

Guidelines 

OPPTS 870.7485 
viii 

The Order does not require submission of the above pended testing at any specified time or 

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

in commerce, usc, and disposal of the PMN substances will remain in effect" until the Order is 

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

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

(a) Scope. T~e requirements of this Or~ r apply to all commercial_ manufacturing, proce ~, 

distribution in commerce, use and disposal of the chemical substances PJ 5-59-

P15-60 -

;and P-lS-104 -

("the PMN 

substances") in the United States by Nanosys, Inc. ("the Company"), except to the extent that 

those activities are exempted by paragraph (b). 

(b) Exemptions. \1anufac turing, processing, distribution in commerce, usc 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 rccordkeeping as 

required in the Recordkceping section of this Order. 
- 2 -

(1) Export. Until the Company begins commercial manufacture ofthc PMN substances 

for use in the United Stat.es, the requirements of this Order do not apply to manufacture, processing 

or distribution in commerce ofthe PlvfN substances solely for export in accordance with TSCA 

§§ l2(a) and 12(b), 40 CFR 720.3(s) and 40 CFR Part'707. However, once the Company begins to 

mrmufacture a PMN substance for use in the United States, no further activity by the Company 

involving the PMN substance is exempt as "solely for export" even if some amount ofthe PMN 

substance is later exp01ted. At that point, the requirements of this Order apply to all activities 

associated with the P.MN substance while in th~ teJ,Titory of the United Sta_tes. Prior to leaving 

U.S. tenitory, even those quantities or batches of the PMN substance that arc 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. 

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

manufacturing, processing, distribution in commerce, use and disposal ofthc 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. The requirements of this Order also do not apply to manufacturing, 

processing, distribution in commerce, use and disposal of the PMN substances when manufactured 

solely for non-commercial research and development per TSCA §S(i) and 40 CFR 720.30(i). 

(3) Bvproducts. The requirements of this Order do not apply to the PMN substances when 

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

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

(4) No Separate Commercial Pul])ose. The requirements ofthis Order do not apply to the 

PMN substances when they arc manufactured, pursuant to any of the exemptions in 40 CFR 

720.30(h), witi1 no commercial purpose separate from the substance, mixture, or articl~ of which it . . 
- 3 -

is a part. 

(5) Imported Articles. The requirements of this Order do not apply to the PMN substances 

when they are imported as part of an "article" as defined at 40 CfR 720.3(c) and in compliance 

·with 40 CFR 720.22(b)(l). 

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

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

("LYE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)(4) and 40 CFR 

723.50(c)(l) and (2) respectively. any such exemption is automatically rendered null and void as 

of the effective date of this Consent Order. 

H. TERMS OF MANUFACTURE ONCLUDING IMPORT}, PROCESSING, 

DISTIUBUTION IN COMMERCE. USE. AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHIBITION 

The Company is prohibited from manufacturing (defined by statute to include import), 

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 and environmental 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 8(e) 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 rep01icd· w1der TSCA section 8( e)· shall reference the 

appropriate PMN identification number for the substance and contain a statement that the 

substance is subject to this Consent Order. Additional information regarding section 8(e) reporting 

requirements can be found at ·www.epa.gov/opptltsca8e. 

(b) Notice of Studv Scheduling. The Company shall notify, in writing, the EPA Monitoring 

Assistance and Media Programs Division (2227A), 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 l?e perfonned 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 will conduct the study; 

(3) The name and telephone number of a person at the Company ~r the laboratory whom 

EPA may contact regardi ng the study; and, 

(4) The appropriate P~v1N identification number for each substance and a statement that the 

substance is subject to this Consent Order. 

The written notice should be submitted to EPA as follows: 

Postal Mail Address 

U.S. Environmental Protection Agency 
- 5 -

GLP Section Chief- Pesticides, Water and Taxies 13ranch 

Monitoring Assistance and Media Programs Division (2227 A) 

Office of Enforcement and Compliance Assurance 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 

Courier Delivery Address 

U.S. Environmental Protection Agency 

GLP Section Chief- Pesticides, Water and Taxies Branch 

Monitoring Assistance and Media Programs Division (2227A) 

Office of Enforcement and Compliance Assurance 

Room 71 178 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20004· 

(c) Good Laboratory Practice Standards and Test Protocols. Each study in paragraph d(2) must be 

conducted according to TSCA Good Laboratory Practice Standards at 40 CFR Patt 792 and using 

methodologies generally accepted in the relevant scientific community at the time the study is 

initiated. Before starting to conduct any study that will use a modified version of a published test 

guideline, the Company must submit written test protocols to EPA for review (submission of 

written test protocols is optional for tests that arc to be conducted using unn10dified published test 

guidelines). Protocols must be submitted as a support document for the PMN, using the 

procedures set out in 40 Cf'R 720.40. EPA will respond to the Company within 4 weeks of 
- 6 -

receiving the written protocols. EPA review of a test protocol does not mean pre-acceptance of 

test results. 

(d) Triggered Testing Requirements: (1) Within 3 months of signing the Consent Order·, the 

company will provide the following material characterization test data for P-15-59; 

(i) Using transmission electron microscopy (provide im(_lges), dry and liquid particle size 

distribution/counting methods, characterize size, shape, morphology, surface area, particle size 

distribution, aggregation/agglomeration state. 

(ii) X-ray diffraction for the presence of crystalline phases. 

(iii) Surface chemistry (including elemental composition) by x-ray photoelectron spectroscopy. 

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

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

Manufactured Nanomaterials: OECD's Sponsorship Programme; First Revision, 2009 

(ENV/JM/MONO 2009). 

(2) Within 1 8 months of signing the Consent Order the Company shall submit to EPA the results 

of a study to measure release of P- 15-59 from the article (film) which it is incorporated into. This 

article is contained in· an electronic display device. The study protocol shall be designed to 

emulate both the usage of the article (film) incorporating P-15-59 during a 5- year consumer usage 

in an electronic display device as well as the potenti al release of P-15-59 from the article after use 

(i.e, disposal in a landfill). Cadmium will be measured to determine ifP-15-59 is released. The 

Company and EPA shall agree to a protocol for the study within six months of signing the consent 

order. 
- 7 -

An example study protocol reflecting the key concepts for the study is shown below: 

• Prepare test articles (film) consistent with this consent order 

o test articles (film) initial baseline testing 

• Wipe test to determine amount of cadmium on surface 

• Wash test with deionized water to determine amount of cadmium that can be 

released from the surface 

o test articles (film) use life aging simulation test 

• High intensity blue light exposure (as used in product application) with 

100% humidity and 160 degrees F temperature for 137 days 

• Collect all condensate and send sample to lab for testing once per month 

o test articles (film) after use life aging simulation test 

• Perform water immersion, TCLP, STLC, and TTLC test to determine 

available cadmium, which wiU be used as an indicator of the amount ofP15-59 released during disposal in a landfill. 

o All measured cadmium amounts at the above noted test points will be reported to 

EPA 

(e) Test Reports. The Company shall: (1) conduct each study in good faith, with due care, and in 

a scientifically valid manner; (2) promptly furnish to EPA the results of any inter.irn phase of each 

study; and (3) submit the final report of each study (with an additional sanitized copy, if 

confidenti al business information is involved) and all underlying data ("the report and data") to 

EPA prior to exceeding the applicable production limit. The final report and data must be 

submitted as a support document for the PtvfN, using the procedures set out in 40 CFR 720.40. 
- 8 -

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 subpru·agraphs shall be interpreted to mean "shall" to make clear 

that the submission of such information is mandatory. EPA will require the submission of raw 

data such as slides and laboratory notebooks only ifEPA finds, on the basis of professional 

judgment, that an adequate evaluation of the study cannot take place in the absence of these items. 

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

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

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

the Company may continue to manufactme 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 (c) (except that the study may be submitted after reaching the applicable 

production limit). The testing requirements may be modified, as necessary to permit a reasoned 

evaluation of the risks presented by the PMN substru1ces, onJy by mutual consent of EPA and the 

Company. 

(h) EPA Determination of lnvalid Data. 

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

test report and data, the Company receives written notice that EPA finds that the data generated by 
- 9 -

a study are scientifically invalid, the Company is prohibited from further manufacture of the PMN 

substances beyond the applicable production limit. 

(2) The Company may continue to manufacture 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) If there is sufficient time to reconduct the study in compliance with paragraphs 

(b), (c), and (e) before exceeding the production limit specified in paragraph (d), the Company 

may reconduct the study. If there is insufficient time to reconduct the study in compliance with 

paragraphs (b), (c), and (e) before exceeding the production limit specified in paragraph (d), the 

Company may exceed the production limit, but must otherwise comply with paragraphs (b), (c), 

and (e). and shall submit the report and data to EPA within a reasonable period of time, all as 

specified by EPA in the notice described in subparagraph (h)(l). 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 \IVfiting, within 4 weeks of receiving the Company's repm1. 

(i) Company Determination of Invalid Data. 

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

circumstances clearly beyond the control of the Company or laboratory \1\l}ll prevent, or have 

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

and (e), the Company remains prohibited from fm1her manufacture of the PMN substances beyond 

the applicable production limit. 
- I 0 -

(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 

,..,111 notify the Company of its response, in writing, within 4 weeks ofreceiving the Company's 

report. EPA's written response may either: 

(i) allow the Company to continue to manufacture the PlVIN substances beyond the 

applicable production limit, or 

(ii) r~quire the Company to cont_inue to conduct, or to reco!1duct, the study in 

compliance with paragraphs (b), (c), and (e), if there is sufficient time to conduct or reconduct the 

study and submit the report and data to EPA before exceeding the production limit specified in 

paragraph (d). If there is insufficient time for the Company to comply with paragraphs (b), (c), 

and (e) before exceeding the production limit specified in paragraph (d), the Company may exceed 

the production limit, but must otherwise comply with paragraphs (b), (c), and (e), and shall submit 

the repo1t and data to EPA ·within a reasonable period of time, all as specified by EPA in the notice 

described in subparagraph (i)(2). EPA will respond to the Company, in writing, within 6 weeks of 

receiving the Company's repo1t and data, as to whether the Company may .continue to manufacture 

beyond the applicable production limit. 

(j) Unreasonable Risk. 

EPA may notif·y the Company in writing that EPA finds that the data generated by a study 

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

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, 
- 11 -

manufacture, processing, distribution, use and/or disposal of the PMN substances to mitigate 

exposures to or to bet1er characterize the risks presented·by the PMN substances. Within 2 weeks 

from receipt of such a notice, the Company must cease all manufacture, processing, distribution, 

use and disposal of the PMN substances, unless either: 

(1) within 2 weeks from receipt of the EPA notice, the Company complies with 

such requirements as the notice specifies; or 

(2) within 4 '"'eeks from receipt of the EPA notice, 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, 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 ,•,reeks of receipt of EPA's written response, the 

Company shall comply with any requirements imposed by EPA's response or cease all· 

manufacture, processing, distribution, use and disposal of the PMN substances. 

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

section, the Company must continue to obey all the terms of this Consent Order until otherwise 

notified in writing by EPA. The Company may, based upon submitted test data or other relevant 

information, petition EPA to modifY or revoke provisions of this Consent Order pursuant to Part 

VI. of this Consent Order. 
- 12-

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 substance), the Company 

must establish a program whereby: 

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

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

through contact with equipment on which the substance may exist is required to wear, personal .. . . . 

protective equipment that provides a barrier to prevent dermal exposure to the substance in the 

specific work area where it is selected for use. Each such item of personal protecti ve equipment 

must be selected and used in accordance with Occupational Safety and Health Administration 

("OSHA") dermal protection requirements at 29 CFR 1910.1 32, 19 10.1 33, and 1910. 138. 

(2) Specific Dem1al Protective Equipment. The dermal protective equipment required by 

subparagraph (a)(l) of this section must include, but is not limited to, the following items: 

(i) Gloves. 

(3) Demonstration of Imperviousness. The Company is able to demonstrate that each item 

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

prevent dermal exposure during nom1al and expected duration and conditions of exposure within 

the work area by any one or a combination of the following: 

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

clothing and the const:r·uction 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 
- 13 -

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 Permeation of Liquids and Gases through Protective . . 

Clotliing Materials under Conditions of Continuous Contact." Results shall be reported as the 

cumulative permeation rate as a function of time, and shall be documented in accordance with 

ASTM F739 using the format specified in ASTM F1 194-99(20 1 0) "Standard Guide for 

Documenting the Results of Chemical Permeation Testing of Materials Used in Protective 

Clothing Materials." Gloves may not be used for a tirne 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 fi·om the 

manufacturer or supplier ofthe 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 PlvfN substances alone and in likely combination with other chemical substances in the work 

area. 

MANUFACTURING 

(a)(J) Prohibition. The Company shall not cause, encourage, or suggest the manufacture of the 

PlvfN substances by any other person. 

(2) Sunset following SNUR. 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 

scckingjud l review of the S~UR. Jfthe Company is so notified, subparagraph (a)(l) shall not 
- 14-

expire until EPA notifies the Company in ·writing that all Federal Court actions involving the 

SNUR have been resolved and 01e validity of the SNUR affirmed. 

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

suoparagraph (a)(l) expires In accordance with subparagraph (a)(2), the Compruiy shall notify each 

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

existence of the SNUR. 

(4) Subparagraph (a)(2) shall not negate the effects of any fully executed c.onsent Order 

for Conh:act Manufacturer entered i_nto under paragraph (b)(2)_. 

(b) Contract Manufacturer. Notwithstanding paragraph (a), the Company may cause the Contract 

Manufacturer(s) identified in the Consent Order for Contract Manufacturer in Appendix C to 

manufacture the PMN substances according to the following conditions (the Company may 

petition EPA pursuant to Section VI of this Order to include additional Contract Manufactmers): 

( 1) The Contact Manufacturer must be under contract to the Company to manufacture the 

PMN substances solely for the Company. The contract must specify the identity of the PMN 

substances, the total quantities to be manufactured, and the basic technology to be used for 

manufacturing. 

(2) The Company shall obtain from each Contract Manufacturer a signed copy of the 

Consent Order for Contract Manufacturer (attached to this Order as Attachment C) and submit the 

copy to EPA along with the name, address, and telephone number of a responsible official of the 

Contract Manufacturer. The Contract Manufacturer or Company must receive a fully executed 

copy of the Consent Order for the Contract Manufacturer from EPA before the Contract 

Manufacturer may begin manufacture. 
- 15-

(3) If at any time, the Company learns that the Contract Manufacturer has failed to comply 

with any of the conditions specified in the Consent Order for Contract Manufacturer, the Company 

shall immediately cease to cause the Contract Manufacturer to manufacture the Pl\1N substances, 

tin less the Contract Manufacturer is in compliance vvith a SNUR for the PMN substances, or unless 

the Company is able to document each of the following: 

(i) That the Company has, within 5 working days, notified the Contract 

Manufacturer in writing that the Contract Manufacturer has failed to comply with the conditions 

specified in the Consent Order for Contract Manufacturer. 

(ii) That, within IS working days of notifying the Contract Manufacturer of the 

noncompliance, the Company received from the Contract Manufacturer, in \¥riting, a statement of 

assurance that the Contract Manufacturer is aware of the tenns of the Consent Order for Contract 

Manufacturer and will comply with those terms. 

(iii) If, after receiving a statement of assurance from the Contract Manufacturer under 

subparagraph (B) of this Section, the Company has notice or knowledge that the Contract Manufactm-er 

has failed to comply with any of the conditions specified in the Consent Order for Contract 

Manufacturer, the Company shall immediately cease to ca use the Contract Manufacturer to 

manufacture the Pl'v1N substances, shall notify EPA of the failure to comply, and shall resume causing 

the Contract Manufacturer to manufacture the PMN substances only upon written notification from the 

Agency 

(b) The Company shall manufacture, process, or use the PMN substances only in a liquid 

fonnulation. 

(c) The Company shall manufacture, process and use P-lS-59 only as a down-converter for an 

optical filter for LEOs used in displays and P- 15-60 and P-15-1 04 only as chemical intennediates. 
- 16 -

DISTRII3UTJON 

(a) Export Noti ce Requirement. No later than the date of distribution, the Company shall notify in 

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

Consent Order under section 5(e) ofTSCA, the P:t-.1N substances are subject to the export 

notification requirements ofTSCA section 12(b) and 40 CPR Part 707 Subpart 0 . Such notice 

shall contain, in the fonn in which it appears in this Consent Order, the following infom1ation: ( 1) 

th~ PMN number, and (2) either (A) the specific chemic;al identity of the P:t-.1N ~stances, or (B) if 

the specific chemical identity is confidential, the generic chemical identity. 

(b) Distribution Requirements. Except as provided in paragraph (c), the Company shall distribute 

the PMN substances outside the Company, other than for disposal, only to a person who has 

agreed in writing prior to the date of distribution, to: 

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

issuance of this Consent Order w1dcr section 5(e) ofTSCA, the PMN substances are subj ect 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 substance to any other person, other than for disposal, 

until after the PMN substance has been incorporated into an article (film). 

(3) Comply with the same requirements and restrictions, if any, required of the Company 

in the Protection in the Workplace. 
- I 7-

(4) Comply with the same environmental release restrictions, if any, required of.the 

Company in the Disposal section of this Order. 

(5) Not use P-15-59 other than as a down-converter for an optical filter for LEDs used in 

displays, use P-15-60 or P-15-104 as chemical iJ1termediates or use any of the PMN substances in 

the form of a solid. 

(c) Temporary Transport and Storage. Not\vithstanding paragraph (b), the Company may 

distribute the PMN substances outside the Company for temporary transport and storage in sealed 

containers provided the following three 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 a person who has given the Company 

the written agreement required by paragraph (b). 

(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 is in the possession and control of the Company or a person who has given the 

Company the written agreement required by paragraph (b). 

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

PMN substances, the Company obtains knowledge that a recipient of the substance has failed to 

comply with any of the conditions specified in paragraph (b) ofthis Distribution section or, after 

subparagraph (b)(2) expires in accordance ·with subparagraph (e)(l), has engaged in a significant · 

new use of the PMN substances (as defined in 40 CFR Part 72 1, Subpart E) without submitting a 

significant new use notice to EPA, the Company shall ~ease supplying the substance to that 
~ 18 -

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 conditions specified in paragraph (b) of this 

Distribution section; or has engaged in a significant new use of tl1e 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 

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

aware of the terms of paragraph (b) 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 (d)(2) 

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

with any of the conditions specified in paragraph (b) of this Distribution section, or has engaged in 

a significant new use of the PMN substances without submitting a significant new use notice to 

EPA, the Company shall cease supplying the PMN substances to that recipient, shaJI notify EPA of 

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

\~Titten notification from the Agency. 

(e) Sunset Following SNUR. (1) Subparagraph (b)(2) ofthis Distribution section shaJJ expire 75 

days after promulgation of a final SNUR for 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 of the SNUR. Jfthc Company is so notified, subparagraph (b)(2) of this 
- 19 -

Distributi on section shall not expire until EPA notifies the Company in writing that all Federal 

Cow-t actions involving the SNUR have been resolved and the validity of the SNUR affirmed. 

(2) When EPA promulgates a final SNUR for the PMN substances and subparagraph (b )(2) of this 

Distribution sectio'n expires in accordance v,iith subparagraph (e)(J ), the Company shall notify each 

person to whom it distributes tbe PMN substances ofthe existence of the 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 f ederal Register or the Code of Federal Regulations. After 

promulgation of a SNUR and expiration. of subparagraph (b )(2), such noti ce may substitute for the 

written agreement required in the introductory clause ofpru·agraph (b); so that, if the Company 

provides such notice to the persons to whom it distributes the PMN substances, then the Company 

is not required to obtain from such persons the written agreement specified in paragraph (b). 

DISPOSAL 

The Company shall dispose of the PMN substru1ces and any waste stream containing the PMN 

substances only as follows. This provision does not supersede or preempt ru1y applicable federal, 

state, ru1d local laws and regul ations if those laws are more stringent than the requirements below. 

(1) The PMN substances must be disposed of only by incineration in a permitted 

hazardous waste incinerator. 
- 20 -· 

III. RECORDKEEPING 

(a) Records. The Company shall maintain the following records until 5 years after ti1e date they 

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

section II ofTS'CA: 

(1) Exemptions. Records documenting that the PMJ\1 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 Hie 

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

eligible for the export only exemption in Section I, Paragraph (b )(1) 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, 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 U1e research and development exemption in Section I, Paragraph (b)(2) 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 720.78(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 volume of the PMN substances and the 

corresponding dates of manufacture; 

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

address, if different) of all persons outside the site of manufacture to whom the Company directly 
- 21 -

sel ls or transfers the PMN substances, the date of each sale or transfer, and the quantity of the 

substance sold or transferred on such date; 

( 4) Records documenting the address of all sites of manufacture, processing, and use; 

(5) Records documenting establishment and implementati'on of a program for the use of 

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

section ofthis Order; 

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

and distribution restrictions in the Manufacturing, Proc~ssing, Use, and Distribution sections of 

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

Order; 

(7) Records docwnenting compliance with any applicable disposal requirements under the 

Disposal section of this Order, including method of disposal, location of disposal sites, dates of 

disposal, and volume ofPMN substances disposed. Where the estimated disposal volume is not 

known to the Company and is not reasonably ascertainable by the Company, the Company must 

maintain other records which demonstrate establishment and implementation of a program that 

ensures compliance with any applicable disposal requirements; 

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

section of this Order, if applicable; and, 

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

substances are manufactured. 
- 22-

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

of the Company and its Contract Manufacturer, if applicable, 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, particulady 5 CFR 1320.5(b ), the Company is not required to respond to this "collection of 

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

Management and Budget ("OMB"),.and EPA so informs the C.ompany. The "collection qf 

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

OMB Control Number 2070-0012. 

lV. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA's Request for Infom1ation. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA 

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

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

the Company in advance to request infom1ation pertinent to the scheduling and conduct of such 

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

include, but are not litnitcd to, the following: 

(1) Expected dates and times when the PMN substances will be in production within the 

subsequent 12 months; 

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

the PMN substances and may reasonably be exposed to the PMN substances; . . 
- 23-

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

with the PMN substances and may reasonably be exposed to the P.MN substances; 

(4) 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; 

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

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

conducting an inspection for that purpose. 

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

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

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

known to or reasonably ascertainable by 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 

tmder this Order may be transferred when the Company transfers its interests in the PMN 
-24-

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 a PM"l'q 

substance from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit a 

new. PMN to EPA and comply_ fully with Section 5(a)(l) pf TSCA and 40 CFR part _720 before 

commencing manufacture of a PMN substance. 

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

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

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

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

(1) "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 term 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 720.22(a)(3) and 40 CFR 720.3(z). 
- 25-

(2) "Transfer Document" means the legal instrument(s) us~d to convey th~ 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 and the "Notice of Transfer" document which is incorporated by reference as Attaclunent B 

to this Order. 

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

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

The \vritten notice should be submitted to EPA as follows: 

Postal Mail Address 

U.S. Environmental Protection Agency 

New Che'micals Management Branch (7405M) 

1200 Peru1sylvania A venue, N. W. 

Washington, D.C. 20460 

Courier Deliverv Address 

U.S. Envirorunental Protection Agency 

New Chemi cals Management Branch (7405M) 

1201 Constitution Avenue, N.W. 

Washington, D.C. 20004 
-26-

(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. Copies of the Transfer Document must also be made available for inspection 

pursuant to Section 11 ofTSCA, 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) Liabilitv. 

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

the effective date of the transfer described above. 

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

Order effective as ofthe date of transfer. 

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

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

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

in commerce, or disposed of the PMN substances pursuant to the terms of this Con.sent Order. 

(f) Obligations to Submit Test Data under Consent Order. If paragraph (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 vohune of the PMN ·substances manufactured by the 

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

in I nteresl. 
- 27 -

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new information on the human 

health or environmental effects of, or human exposure to or environmental release of, the PMN 

substances, to modify or revoke substantive provisioris of this Order. The expo.sures and risks 

identified by EPA during its review ofthe PMN substances and the information EPA determined 

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

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

information available at the time the Agency makes th~t detenn.ination, including, where . 

appropriate, any reassessmentofthe 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 bealtl1 or the cnviromnent and will not 

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

absence of data sufficient to permit a reasoned evaluation of the health or environmental effects of 

the PivfN substances. 

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

language ofthis Order. EPA will issue such a 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) ofTSCA, to receive service of this Order no 

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

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

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

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

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

(b) CBI Brackets. 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 J 4 ofTSCA, 40 CFR Part 720 Subprut E, and 40 CFR Part 2) is correctly 

identified within brackets and that any infom1ation that is not bracketed is not claimed as 

confidential. To make this document available for public viewing, EPA will remov~ only the 

information contained within the brackets. 

)5 

Date Maria J. Doa, P 1 ., Director 

Chemical Control Division 

Office ofPollution Prevention and Toxics 

Title: "4Li.s .'I)~~ A,.c .... c.:o 

Nru1osys, Inc 
ATTACHMENT A 

DEFINITIONS 

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

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

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

nomenclature, or a name which will clearly identif·y a chemical substance for the purpose of 

conducting a hazard evaluation. 

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

prevent dermal contact with chemical substances of concern. Examples can include, but arc not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

"Company" means the ·person or persons subject fo this Order. 

"Commercial use" means the use of a chemical substance or any mixture containif!g 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 I:ecrea1t011, Or for any persona] USe Or enjoyment. . . . 

"Consumer product" means a chemical substance that is directly, or as part of a mixture, 

sold or made avai !able 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 ptuvoscs of this section, pipes or piping 

systems, ru1d 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 the PMN substance under the conditions specified in Pru1 II. of this Consent Order 

ru1d in the Consent Order for Contract Manufacturer. 

"Identity" means ru1y 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 labeled 

container. 

':Impervious." Chemical protective clothing is " impervious" to a chemical substance if the 

substance causes no chemical or mechanical de.gradation, permeation, or penetration of the 

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

"ManufactuJing strean1'' 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. 

Depru1ment 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 usc" means use other tl1an at a facility where chemical substances or 

mixtures are manufactured or processed. 

"PMN substances" means the chemical substances described in the Prcmanufacture 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 

substru1ces in tl1e work area. Examples include, but are not limited to, chemical protective 

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

vru·ious types of respirators. Banier creams are not included in this definition. 

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

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

processing, including the cleaning of equipment. 

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

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

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

substance. 
3 

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

confom1ity with the Good Laboratory Practice Standards and EPA-reviewed protocols, are 

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

the potential risk of injUJy 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 containnient of the Plv1N substance, and from which there will be no human exposure io, 

nor environmental release of, the PMN substance during transpo11 and storage. 

"Use stream" means all reason.ably 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 arc 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 S(c) CONSENT ORDER 

PMN Number 

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

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

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

the subject of a premanufacture notice ("PMN'') and is govemed 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(c)). 

2. Assumption ofLiability. The Successor in Interest hereby cer1ifies that, as of the effective date 

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

manufacture, processing, use, distribution in conunerce and disposal of the PMN substance, shall 

be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is 

incorporated, licensed, or doing business in the United States in accordance with 40 CFR 

720.22(a)(3). 

3. Confidential Business Information. The Successor in Interest hereby: 

_ reasserts, 

_ relinquishes, or 

modifies 

aJJ Confidentia l Business Information ("CI3I") 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. 
11 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

(continued) 

Company r~ ro ) PMN Number. 

Signature of Authorized O fficial Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Inter est 

- Signature of Authorized Official Date 

Printed Name· of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 
Ill 

NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone