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ATTACHMENT C 

UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENfiON AND TOXICS 

' . REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

In the matter of: ) Premanufacture Notice Numbers: 

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SAFC Hitech ) P-15-59/60/104 

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Consent Order for Contract Manufacturer 
CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

(a) Scope, SAFC Hitech ("the Contract Manufacturer'') has entered into a contract with Nanosys, 

Inc. ("the Company") to manufacture (defined by statute to include import) exclusively for the 

Company the chemical substances PlS-59-

PlS-60-

and P-15-104-

("the PMN substances"). The requirements of 

this Order apply to all commercial manufacturing, processing, distribution in commerce, use and 

disposal of the chemical substances by SAFC Hitech ("the Contract Manufacturer'') except to the 

extent that those activities are exempted by paragraph (b). 

(b) Exemptions. Manufacturing, 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 OfConscnt 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. 

(1) Export. Until the Contract Manufacturer 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 12{b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the 

Contract Manufacturer begins to manufacture a PMN substance for use in the United States, no 

further activity by the Contract Manufacturer involving the PMN substance is exempt as "solely 

for CXPort" even if some amount ofthe PMN substance is iatcr exported. ~t that .Point, the 

requirements of this Order apply to all activities associated with the PMN substance while in the 

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

PMN substance that are destined for export are subject to tenns of the Order, and count towards 

any production volume test triggers in the Testing section of the Consent Order for the Company. 

. . (2) 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. 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 §5(i) and 40 CFR 720.30(i): · 

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

they arc produced, without separate commercial intent, only as a "byproducf' as defined at 40 CFR 

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

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

PMN substances when they are manufactured, pursuant to any of the ~xemptions in 40 CPR 

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

is a P.art. 

(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 
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with 40 CFR 720.22(b)(l). 

(c) Automatic Sunset. lfthe Contract Manufacturer has obtained for a PMN substance a Test 

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

. . ' . Exemption ("L VE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)( 4) 

and 40 CFR 723.50(c)(l) and (2) respectively, any such exemption is automatically rendered null 

and void as ofthe effective date of this Consent Order. 

II. TERMS OF MANUFACTURE UNCLUDING IMPORT), PROCESSING. 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROIDBITION 

As a condition of manufacturing the PMN substances for the Company, the Contract 

Manufacturer is prohibited from manufacturing, 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 ofthe human health 

and environmental effects of the substances, and the completion <:>fEPA's review of, and 

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

this Order. 

PROTECTION IN THE WORKPLACE 

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

at any site controlled by the Contract Manufacturer (including any associated packaging and 
storage and during any cleaning or maintenance of equipment associated with the PMN substanee ), 

the Contract Manufacturer must establish a program whereby: 

(l) Genera! Dennal Protection. Each person who is reasonably likely to be dermally 

e'x~sed in the work area to the PMN substances thrci~gh direet handling of the ~ubstance or 

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

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

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

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

("OSHA.,) dermal protection requirements at 29 CFR 1910.i32, 1910.133, and 1910.138. 

(2) Specific Dermal Protective Equipment. lbe 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 Contract Manufacturer is able to demonstrate 

that each item of chemical protective· clothing selected, including gloves, provides an impervious 

barrier to prevent d~nnal exposure during normal 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 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 prot~ctive clothing to the expceted 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 Permeation of Liquids and Gases through Protective 
Clothing Materials Wlder Conditions of Continuous Contact." Results shall be reported as the 

cwnulative pcnneation rate as a ftmction of time, and shall be docwncntcd in accordance with 

ASTM F739 using the format specified in ASTM Fll94-99(2010) "Standard Guide for 

. , .. . · Documenting the ResultS of Chemical P~rmeation Testing of Materials Used in Protective 

Clothing Materials." Gloves may not be used for a time period longer than they are aetually tested 

and must be replaced at the end of caeh work shift during whieh they are exposed to the PMN 

substances. 

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

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m~ufacturer or supplier of the chemica] protective clothing, or of the materia] used in 

construction of the elothing, to establish that the ehemieal protective clothing will be impervious to 

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

area. 

MANUFACTURING 

(a)(l) Prohibition. The Contraet Manufacturer shall not begin manufacture ofthe P:M:N substanees 

until the Contraet Manufaeturer or the Company reeeivcs a fully exeeuted eopy of the Consent 

Order for Contract Manufacture from EPA. 

(2) The Contmct Manufacturer shall not cause, encourage, or suggest the manufacture of 

the PMN substances by any other person, except the Company. 

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

of a final significant new use· rule ("SNUR") govc~g the PMN substanees under seetion 5(a)(2) 

ofTSCA unless the Contract Manufacturer is notified on or before tha:t day of an aetion in a 

Federal Court seeking judicial review of the SNUR. If the Contract Manufacturer is so notified, 
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subparagraph (a)(l) shall not expire until EPA notifies the Contract Manufacturer in writing that 

all Federal Court actions involving the SNUR have been resolved and the validity of the SNUR 

affirmed. 

(4) Notice ofS'NUR. When EPA promulg~tes a final SNURfor tlie.PMN substances and 

subparagraph (a)(l) expires in accordance with subparagraph (a)(2), the Contract Manufacturer 

shall notify each person whom it causes, encourages or suggests to manufacture the PMN 

substances of the 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 usc notification to EPA for the PMN substances. 

Such notice must also reference the publication of the SNUR for the PMN substances in either the 

Federal Register or the Code of Federal Regulations. 

DISTRIBUTION . 

(a) The Contract Manufacturer shall distribute the PMN substances only to the Company or as 

described in paragraph (c). 

(b) Export Notice Requirement. No later than the date of distribution, the Contract Manufacturer 

shall notify in writing any person to whom it distributes the PMN substances that, due to the 

issuance of this Consent Order under section S(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 fonn in which it appe~s in this Consent Order, the following 

information: (I) the PMN number, and (2) either (A) the spscific chemical identity ofthc PMN 
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substances, or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(c) .Distribution Requirements .. Except as provided in paragraph (d), the Contract Manufacturer 

. . . 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 under section S(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 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) Comply with the same requirements and restrictions, if any, required of the Contract 

Manufacturer in the Protection in the Workplace. 

· (3) Comply with the same environmental release restrictions, if any, required of the 

Contract Manufacturer in the Disposal section of this Order. 

- (4) Not usc P-15-59 other than as a down-converter for an optical filter for LEOs used in 

displays, use P-15-60 or P-15~104 as chemical intermediates or use any ofthe PMN substances in 

the form of a solid. 

(d) Temporary Transport and Storage. Notwithstanding paragraph (a), the Contract Manufacturer 

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

sealed containers provided the following three conditions are met: 

(I) Subsequent to any such exempt temporary transport or storage of sealed containers, the 
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PMN substances may be distributed only to the Company, the Contract Manufacturer or a person 

who has given the Company the written agreement required by paragraph (c). 

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

containers and remo~ing or washing out the .PMN substances may occtir ·only while the PMN 

substances is in the possession and control of the Company, the Contract Manufacturer, or a person 

who has given the Company the written agreement required by paragraph (b). 

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

PMN substances, the Company or the Contract Manufacturer 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 usc of the PMN substances (as defined in 40 CFR Part 721, 

Subpart E) without submitting a significant new use notice to EPA, the Contract Manufacturer 

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

ofthc following: 

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

recipient has fail<;d to comply with any ofthc conditions specified in paragraph (b) 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 J 5 working days of notifying the recipient of the noncompliance, the 

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

aware ofthe tcnns of paragraph (b) ofthis Distribution section.and will comply with those terms, 

or is aware of the terms of the significant new usc 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 ofassuranee from a recipient under subparagraph (d)(2) 

of this Distribution section) the Company or the Contract Manufacturer obtains knowledge that the 

recipient has failed. to comply with any of~ conditions specified in p~agraph (b) of this 

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

submitting a significant new use notice to EPA, the Contract Manufacturer shall cease supplying 

the PMN substances to ~at 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. 

(f) Sunset Following SNUR. (1) Subparagraph (b)(2) ofthis Distribution section shall expire 75 

days after promulgation of a final SNUR for the PMN su~stances under section 5(a)(2) ofTSCA, 

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

seeking judicial review of the SNUR. If the Contract Manufacturer is so notified, subparagraph 

(b )(2) of this 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. 

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

Distribution section expires in accordance with subparagraph (e)(l), the Company shall notify each 

person to whom it distributes the PMN substances of the 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 Federal Register or the Code of Federal Regulations. After 
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promulgation of a SNUR and expiration of subparagraph (b )(2), such notice may substitute for the 

written agreement required in the introductory clause of paragraph (b); so that, if the Contract 

Manufacturer provides such notice to the p~rsons to whom it distributes. the PMN substances, then . 

the Contract Manufacturer is not required to obtain from such persoris the written agreement · · 

specified in paragraph (b). 

DISPOSAL 

The Co~tract Manufacturer shall dispose of the PMN substances and any waste stream containing 

the PMN substances only as follows. This provision does not supersede or preempt any applicable 

federal, state, and local laws and regulations ifthose laws are more stringent than the requirements 

below. 

( 1) The P:M:N substances must be disposed of only by incineration in a permitted 

hazardous waste incinerator. 

III. RECORDKEEPING 

(a) Records. The Contract Manufacturer shall maintain the following records until5 years after 

the date they arc created and shall make them available for inspection and copying by EPA in 

accordance with section 11 of TSCA: 

(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) ofthis Order. Such records 

must satisfy all the statutory and regulatory r6cordkeeping requirementS applicable to the 

exemption I?cing claimed by the Company. Any amounts or batches of the PMN substances 

eligible for the export only exemption in Section I, Paragraph (b)(l) of this Order are exempt from 
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all the requirements in this Recordkeeping section, if the Contract Manufacturer maintains, for 5 

years from the date of their creation, copies ofthe 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 elfgible for.the research and'd~velopment exemption in.Section I, Paragraph (b)(2) of 

this Order are exempt from all the requirements in this Recordkecping section, if the Contract 

Manufacturer maintains, for 5 years from the date of their creation, the records required by 40 CFR 

720.78(b). For any amounts or batches ofthe PMN substances claimed to be eligible for any other 

exemption described in Section I, Paragraph (b) of this Order, the Contract Manufacturer 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 

Recordkceping 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 Contract 

Manufacturer directly transfers the PMN substances, the date of each transfer, and the quantity of 

the substance transferred on such date; 

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

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

any applicable personal protective equipment required purs~t to the Protection in the Workplace 

section of this Order; 

- (6) Records documenting the determinations requited by the Protection in the Workplace 

section of this Order that chemical protective clothing are impervious to the PMN substances; 
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(7) Records documenting compliance with any applicable manufacturing, processing, use, 

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

this Order, including distributecs' written agreement to comply wit}l the Distribution section of.this 

Order; .. 

(8) Records documenting compliance with any applicable disposal requirements under the 

Disposal section_ ofthis 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 Contract Manufacturer and is not reasonably ascertainable by the Contract 

Manufacturer, the Contract Manufacturer must maintain other records which demonstrate 

establishment and implementation of a program that ensures compliance 'With any applicable 

disposal requirements; 

(9) The Contract Manufacturer shall keep a copy of this Order at each of its sites w}:lere 

the PMN substances arc manufactured. 

(b) Applicability. The provisions of this Rceordkeeping 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, particularly 5 CFR 1320.5(b), the Contract Manufacturer 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-s-o informs the Company.- The "collection 
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of information" required in this TSCA §5(e) Consent Order has ~een approved under currently 

valid OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION' INFORMATION 

(a) EPA's Request forlnfonnation. Pursuant to section 11 ofTSCA and 40 CPR 720.122, EPA 

may oecasionally' conduct on-site compliance inspections of the Contraet Manufaeturer faeilities 

and conveyances associated with the PMN substances. To facilitate such inspections, EPA 

personnel may contact the Contract Manufacturer 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 inqlude; but are not limited to, the following: 

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

subseq:uent 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; 

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

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

(5) Records required by the Rccordkeeping seetion of this Order; and/or, 

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

conducting an inspection for that purpose. 
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(b) Contract Manufacturer's Response. The Contract Manufact\,rrer 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 Contract Manufacturer's response shall be in . . . . 

writing.' To the extent the information is known to or reasonably ascertainable by the'Contract 

Manufacturer at the time of the requ.est, the Contract Manufacturer's response shall demonstrate a 

good faith effort to provide reasonably accurate and detailed answers to all ofEPA's requests. 

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

Contract Manufacturer submits to.EPA pursuant to paragraph (b) shall be protected in accordance 

with §14 ofTSCA and 40 CFR Part 2. 

V. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Contract Manufacturer may petition EPA at any time, based upon new information on 

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

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 arc described in the preamble to 

this Order. However, in detennining 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 infom1ation 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 
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result in significant or substantial hwnan exposure or substantial environmental release in the 

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

the PMN substances . 

. In addition, the Contract Manufacturer may petition EPA at any time to mue other 

modifications to the language of this Order. EPA wil~ issue such a modification ifEPA detennines 

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

Order as issued. 
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VII. EFFECT OF CONSENT ORDER 

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

to file objections to this Order pursuant to section S(e)(l)(C) ofTSCA, to receive service of this 

Orde~ no later than 45 days bCf~rc.the end of the review period pursuant to section.S(e)(l)(B) of . ' . 

TSCA, 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 tenns, do not constitute an admission by the 

Contract Manufacturer as to the facts or conclusions underlying the Agency's detenninations in 

this proceeding. This waiver docs not affect any other rights that the Contract Manufacturer may 

have under TSCA. 

(b) CBI Brackets, By signing this Order, the Contract Manufacturer represents that it has 

carefully reviewed this document and hereby agrees that all infonnation herein that is claimed as 

confidential by the Contract Manufacturer (per section 14 ofTSCA, 40 CFR Part 720 Subpart E, 

and 40 CFR Part 2) is correctly identified. within brn.ckets and that any infonnation that is not 

bracketed is not claimed as confidential. To make this document available for public viewing, 

EPA will remove only the ~nfonnation contained within the brackets. 

Maria J. Doa, P .• Director 

Chemical Control Division 

Office ofPollution Prevention and Toxics 

Name: CIQf)W r f'V : ..... a_ 

Title: Ji.'Co.ll- Pr-L.og,.:~+ 

SAFC Hitceh ,::L""oe-