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ATTACHMENT C UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTION PREVENfiON AND TOXICS ' 

# . REGULATION OF ANEW CHEMICAL SUBSTANCE PENDING DEVELOPMENT OF INFORMATION

In the matter of: ) PremanufactureNotice Numbers: ) ) ) ) ) SAFC Hitech ) P-15-59/60/104 ) ) ) ) )

Consent Order for Contract Manufacturer

### CONSENT ORDER

I. SCOPE OF APPLICABILITY AND EXEMPTIONS (a) Scope, SAFC Hitech ("the ContractManufacturer'') 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 ofthe 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 ofthe PMN substances are exempt from the requirements ofthis 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 ofthis Order. (1) Export. Until the ContractManufacturer begins commercial manufacture ofthe PMN substances for use in the United States, the requirements ofthis Order do not apply to manufacture, processing or distribution in commerce ofthe PMN substances solely for export in accordancewith 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 substanceis exempt as "solely for CXPort" even ifsome amountofthe PMN substance

# is iatcr exported.

### ~t that .Point, the requirements ofthis Order apply to 

### all activities associated with the PMN substance while in the territory ofthe United States. Priorto leaving U.S. territory, even those quantities or batches ofthe 

### PMN substance that are destined for export 

### are subjectto tenns of

### the Order, and 

### count towards any production volume test triggers in the Testing section ofthe 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 ofthe 

### 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 ofthis Order also do not apply to manufacturing, processing, distribution in commerce, use and disposal ofthe 

### 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 ofthis 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 ofthis Order do not apply to the 

### PMN substances when they are manufactured, pursuantto any ofthe**~xemptions** in 40 

### CPR 720.30(h), with no commercial purpose separate from the substance, mixture, or article ofwhich it is a P
. art.

(5) Imported Articles. The requirements ofthis Order do not apply to the PMN substances when they are imported as part ofan "article" as defined at 40 CFR 720.3(c) and in compliance- 3

- with 40 CFR 720.22(b)(l). (c) Automatic Sunset. lftheContract Manufacturerhas 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 ("LVE") or Low Release and Exposure Exemption ("LoREX")under TSCA §5(h)( 4) and 40 CFR 723.50(c)(l) and (2) respectively, any such exemption is automatically rendered null and void 

### as ofthe effective date ofthis Consent Order.

II. TERMS OFMANUFACTURE UNCLUDINGIMPORT), PROCESSING. DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL PENDING SUBMISSION AND EVALUATION OFINFORMATION
PROIDBITION As a condition ofmanufacturing the PMN substances for the Company, the Contract Manufactureris prohibited from manufacturing, processing, distributing in commerce, using, or disposing ofthe PMN substances in the United States, for any nonexempt commercial purpose, pending the development ofinformation necessary for areasoned evaluation ofthehuman health and environmental effects ofthe 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.

PROTECTIONINTHE WORKPLACE (a) Establishment ofProgram
. During manufacturing, processing, and use ofthe PMN substances at any site controlled by the Contract Manufacturer (including any associated packaging andstorage and during any cleaning ormaintenance ofequipment associatedwith the PMN substanee), the Contract Manufacturermust 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 ofthe

### ~ubstance or through contact with equipment on which the substanee may exist is required to wear, personal protective equipment thatprovides abarrier to prevent dermal exposure to the substanee in the specific work area where it is selected for use. Each such item ofpersonal protective equipment must be selected and used inaccordance with OccupationalSafety and Health Administration ("OSHA.,) dermal protection requirements at 29 CFR 1910.i32, 1910.133, and 1910.138. (2) Specific Dermal Protective Equipment. lbedermal protective equipmentrequired by subparagraph (a)(l) ofthis section must include, but is not limited to, the following items: (i) Gloves. (3) Demonstration ofImperviousness. The Contract Manufacturer is able to demonstrate that each item ofchemical 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 ofthe following: (i) Permeation Testing. Testing the material used to make the chemical protective clothing and the construction ofthe clothing to establish that the protective clothing will be impervious for the expected duration and conditions ofexposure. The testing must subject the chemical**prot~ctive** clothing to the expceted conditions ofexposure, including the likely combinations ofchemical substances to which the clothing may be exposed inthe work area. Permeation testing shall be conducted according to the American Society for Testing and Materials ("ASTM") F739 "Standard Test Method for Permeation ofLiquids and Gases through ProtectiveClothing Materials Wlder Conditions ofContinuous Contact." Results shall bereported as the cwnulative pcnneation rate as a ftmction oftime, and shall be docwncntcd in accordance with ASTM F739 using the format specified in ASTM Fll94-99(2010) "Standard Guide for



# . , .. 

### . ·Documenting the ResultS ofChemical**P~rmeation** Testing ofMaterials Used in Protective

Clothing Materials." Gloves may not be used for atime period longerthan they are aetually tested and mustbe replaced at the end ofcaeh work shift during whieh they are exposed to the PMN substances. (ii) Manufacturer's Specifications. Evaluating the specifications from the

. .**m~ufacturer** or supplier ofthe chemica] protective clothing, or ofthe materia] used in construction ofthe elothing, to establish that the ehemieal protective clothing will be impervious to the PMN substances alone and in likely combination with otherchemical 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 ofthe 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 afterpromulgation of

# a final significantnew 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 ofan aetion in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Contract Manufacturer is so notified,

### -6- 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 ofthe 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 ofthe existence ofthe SNUR. Such notification must be in writing and must specifically include all limitations contained inthe SNURwhich are defined as significant new uses, and which would invoke significantnew usc notificationto EPA for the PMN substances. Such notice must also reference the publication ofthe SNUR for the PMN substances in eitherthe Federal Register or the Code ofFederal Regulations.



### DISTRIBUTION
. (a) The Contract Manufacturer shall distribute the PMN substances only to the Company or as described in paragraph (c).
(b) ExportNotice Requirement. No later than the date ofdistribution, the Contract Manufacturer shall notify in writing any person to whom it distributes the PMN substances that, due to the issuance ofthis Consent Order under section S(e) ofTSCA, the PMN substances are subjectto 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-7- substances, or (B) ifthe 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 aperson' who has agreed in writing priorto the date ofdistribution, to: (1) Notify in writing any person to whom it distributes the PMN substances that, due to the issuance ofthis Consent Order under section S(e) ofTSCA, the PMN substances are subject to the exportnotification requirements ofTSCA section 12(b) and 40 CFR Part 707 SubpartD. 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 ofthe PMN substance, or (B) ifthe specific chemical identity is confidential, the generic chemical identity. (2) Comply with the same requirements and restrictions, ifany, required ofthe Contract Manufacturer in the Protection in the Workplace.

· (3) Comply with the same environmental release restrictions, ifany, required ofthe Contract Manufacturer in the Disposal section ofthis Order.



## - (4) Not usc P-15-59 otherthan as a down-converter for an optical filter for LEOs used in displays, use P-15-60 or**P-15~104** as chemical intermediates oruse any ofthe PMN substances in the form ofa 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 ofsealed containers, the-8- PMN substances may be distributed only to the Company, the Contract Manufacturer or aperson who has given the Company the written agreementrequired by paragraph (c). (2) Any human exposure or environmental release resulting from opening the scaled containers and

### remo~ing or washing outthe

# .PMN substances may occtir·only while the PMN substances is in the possession and control ofthe Company, the Contract Manufacturer, or aperson 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 ofthe PMN substances, the Company orthe Contract Manufacturer obtains knowledge that arecipient of the substance has failed to comply with any ofthe 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 ofthe PMN substances (as defined in 40 CFR Part 721, Subpart E) without submitting a significantnew 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 5working 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 significantnew use ofthe PMN substances without submitting a significantnew use notice to EPA. (2) That, within J 5working days ofnotifying the recipient ofthe noncompliance, the Company received

## from the recipient, in writing,'a statement ofassurance ihatthe recipient is
aware ofthetcnns ofparagraph (b) ofthis Distribution section
.and will comply with those terms,
oris aware ofthe terms ofthe significant new usc rule for the PMN substances and will not engagein a significant new use without submitting a significantnew use notice to EPA. (3) If, after receiving a statement ofassuranee from arecipient under subparagraph (d)(2) ofthis Distribution section) the Company orthe Contract Manufacturer obtains knowledge that the recipient has failed.to comply with any**of~** conditions specified in**p~agraph** (b) ofthis

.Distribution section, or has engaged in a significantnew usc ofthe 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 ofthe failure to comply, and shall resume supplyingthe PMN substances to thatrecipient only upon written notification from the Agency.

(f) Sunset Following SNUR. (1) Subparagraph (b)(2) ofthis Distribution section shall expire 75 days afterpromulgation ofa final SNUR for the PMN**su~stances** under section 5(a)(2) ofTSCA, unless the Contract Manufacturer is notified on or before that day ofan action in a Federal Court seekingjudicial review ofthe SNUR. Ifthe Contract Manufacturer is so notified, subparagraph (b)(2) ofthis Distribution section shall not expire until 'EPA notifies the Company in writing that all Federal Court actions involving the SNURhave been resolved and the validity ofthe SNUR affirmed. (2) When EPA promulgates a 

### fmal SNURfor the PMN substances and subparagraph (b)(2) ofthis Distribution section expires in accordance with subparagraph (e)(l), the Company shall notify each person to whom it distributes the PMN substances ofthe existence ofthe SNUR. Such notification must be in writing and must specifically include all limitations contained in the SNUR which are defined as significant'newuses, and which would invoke significantnew·use notification to EPA for the PMN substances. Such notice must also reference the publication ofthe SNUR for these PMN substances in either the Federal Register orthe Code ofFederal Regulations. After- 10- promulgation ofa SNUR and expiration ofsubparagraph (b)(2), such notice may substitute for the written agreement required in the introductory clause ofparagraph (b); 

### so that, ifthe Contract Manufacturerprovides 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 ofthe 

### 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 stringentthan the requirements below. (1) The P:M:N substances must be disposed ofonly 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 ofTSCA: (1) Exemptions. Records documenting that the PMN substances did in fact qualify for any ·
one or more ofthe 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 ofthe PMN substances eligible for the export only exemption in Section I, Paragraph (b)(l) ofthis Order are exempt from- 11**~** all the requirements in this Recordkeeping section, ifthe Contract Manufacturer maintains, for 5 years from the date oftheir creation, copies ofthe export label and export notice to EPA, required by TSCA sections 12(a)(l)(B) and 12(b), respectively. Any amounts orbatches ofthe PMN substances elfgible for.the research**and'd~velopment** exemption in.SectionI, Paragraph (b)(2) of this Order are exempt from all the requirements in this Recordkecping section, 

### ifthe Contract Manufacturer maintains, for 5 years from the date oftheir 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) ofthis Order, the Contract Manufacturer shall keep records demonstrating qualification for that exemption as well as therecords specified in paragraphs (2) and (3) below, but is exempt from the otherrecordkeeping requirements in this Recordkceping section; (2) Records documenting the manufacture volume ofthe PMN substances and the corresponding dates ofmanufacture; (3) Records documenting the names and addresses (including

- shipment destination address, ifdifferent) ofall persons outside the site ofmanufacture to whom the Contract Manufacturer directly transfers the PMN substances, the date ofeach transfer, and the quantity of the substance transferred on such date; (4) Records documenting the address ofall sites ofmanufacture, processing, and use; (5) Records documenting establishment and implementation ofa program for the use of any applicable personal protective equipment required**purs~t** to the Protection inthe Workplace section ofthis Order;

- (6) Records documenting the determinations requitedbythe Protection inthe Workplace section ofthis Orderthat chemical protective clothing are impervious to the PMN substances;- 12- (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 ofdisposal, location ofdisposal sites, dates of disposal, and volume ofPMN substances disposed. Where the estimated disposal volume is not known to the Contract Manufacturer and is notreasonably ascertainable by the Contract Manufacturer, the Contract Manufacturer must maintain otherrecords which demonstrate establishment and implementation ofaprogram that ensures compliance 

### 'With any applicable disposal requirements; (9) The Contract Manufacturer shall keep a copy ofthis Order at each ofits sites w}:lere the PMN substances arc manufactured.

(b) Applicability. The provisions ofthis Rceordkeeping Section are applicable only to activities ofthe Company and its Contract Manufacturer, ifapplicable, and not to activities ofthe Company's customers.
(c) OMB Control Number. Underthe 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 ofinformation" unless this Order displays a currently valid control number from the Office ofManagement and Budget ("OMB"), and EPA-s-o informs the Company.- The "collection- 13- ofinformation" required in this TSCA §5(e) Consent Orderhas**~een** approved under currently valid OMB Control Number2070-0012.

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 ofthe ContraetManufaeturer faeilities and conveyances associated with the PMN substances. To facilitate such inspections, EPA personnel may contactthe ContractManufacturer in 'advance to requestinformation pertinent to the scheduling and conduct ofsuch inspections. Such requests may be written or oral. The types ofinformation 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) Currentworkshift schedules for workers who are involved in activities associated with the PMN substances and may reasonably be exposed to 

### the PMN substances; (3) Currentjobtitles 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 ofthis Order; and/or, (6) Any other information reasonably related to determining**complianc~** with this Order or conducting

# an inspection for thatpurpose.- 14- (b) Contract Manufacturer's Response. The Contract Manufact\,rrer shall respond to such requests within a reasonable period oftime, but in no event laterthan 30 days after receiving EPA's request. When requested in writing by EPA, the Contract Manufacturer's response shall be in



### . . 

### . . writing.' 

### To the extentthe information is known to or reasonably ascertainable by the'Contract Manufacturer at the time ofthe requ.est, the Contract Manufacturer's response shall demonstrate a good faith effortto 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 ofthis Order. The exposures 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 arc described inthe preamble to this Order. However, in detennining whether to amend or revoke this Order, EPA will consider all relevant information available atthe time the Agency makes that determination, including, where appropriate, any reassessment ofthe test data or other information that supports the findings in this Order, an examination ofnew test data or other infom1ation or analysis, and any otherrelevant information: EPA will issue amodification or revocation.ifEPA determines that the·activities proposed therein will not present an unreasonable risk ofinjury to health or the environment and will not- 15- resultin significant or substantial hwnan exposure or substantial environmental release in the absence ofdata sufficient to permit areasoned evaluation ofthe health or environmental effects of the PMN substances
.

. In addition, 

### the ContractManufacturer may petition 

### EPA at any time tomue 

### other modifications to the language 

### ofthis Order. 

### EPA**wil~** issue 

### such amodification 

### ifEPA detennines 

### thatthe modification is useful, appropriate, 

### and consistent with 

### the structure and intentofthis Order as issued.- 16-
VII. EFFECT OF CONSENT ORDER (a) Waiver. By consenting to the entry ofthis Order, the ContractManufacturerwaives its rights to file objections to

### this Orderpursuant to section S(e)(l)(C) ofTSCA, to receive service ofthis**Orde~**no laterthan 45 days**bCf~rc.the** end ofthe review periodpursuantto section.S(e)(l)(B) of



### . ' 

# . TSCA, and to challenge the validity ofthis Orderin any subsequent action. Consenting to the entry ofthis Order, and agreeing to be bound by its tenns, do not constitute an admission by the ContractManufacturer

### as to the facts or conclusions underlying the Agency's detenninations in this proceeding. This waiver docs not affect any otherrights thatthe ContractManufacturermay have underTSCA.

(b) CBI Brackets, By signing this Order, the ContractManufacturerrepresents that it has carefully reviewed this document and hereby agrees that all infonnation herein that is claimed as confidential by the Contract Manufacturer(persection 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.

MariaJ. 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-