## --**anosys~ ~**  233 S. Hillview Drive. Milpitas. CA 95035 Phone: 408-240-6700; F ax: 408-2 40 -6900 WVNI .nanosysinc .co m



# - 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 Cons e nt Order for the above PMNs, please find a · ttached our counte r signed copy of the ) Order. In addi t ion, we are a lso including in this packet the signed version of Attachment C from our subcontractor Sigma Aldrich F ine Chemical (SAFC) as well as just for your information, the signed PMN Notification L etter Agreement from our customer 3M. We will be submitting our Notice of Commencement on-line today as well. If you should have any questions o r co m ments, please do not hesitate to contact me at {408) 838 8005.

Best regards,

# /./**~//** 

# 1'-jL cs:::_ - Jason Hartlove President and CEO N an osys, Inc. Enroi l: jhortlove@nonosysinc
. com (!<
.....UNITED STATES ENVIRONMENTAL PROTECTION AGENCY OFFICE OF POLLUTION PREV ENTION AND TOXICS

, ... " .. . .,. 

# . "'

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

# I : 

# J PENDING D EVE LOPME NT OF . INFORMATION



### In the matter of:

Nanosys, Inc ) ) ) ) ) ) ) ) ) ) ) ) 

### Premanufacture Notice Numbers:

P-15-59/601104**------------·-·-------------·--·------~-** 

### Consent Order, Consent Order for Con tract Manufacturer, and Determinations Supporting Consent Order

---- --·- 

### - -·II 

### TABLE OF CONTENTS Preamble I. 

### Introduct ion Il. S wnmary ofTen:ns of the Order IJI. 

### Con tents ofPMNs IV . EPA's Asse ss ment of Exposure and Risk V. EPA's Conclusions of Law 

### VI. Info rmati on Re quire d to Eval u ate Hu m an Hea lth an d Env i ronme ntal Effects

Consent Order I. 

### Scope of Applicability and Exemptions II. Te rms of Manufacture (defined by statute to inc l ude impo rt), :Process i ng, Distri b ution i n Commerce, Use, and Di s posal Pending Submission and Evaluation oflnformation IIJ. 

### Recordkeeping IV. R eq uests fo r Pre-Inspect ion Information V. Success or Liab ility Upon T ransfer o f Conse nt Order VI. Modification and Revocation of Co n sent Order VII. Effect of Consen t O rder Attachment 

### A
- Definit ions Attachment B
- Notice of Transfer of Consent Order Attachment C- Consent Order for Co ntr act Manufacturer111 

## PREAMBLE
1. I NTRODUCTIO N Under the authority of§ 5(e) of the Toxic Subs tances Control Act ("TSCA") ( 15 U . S.C. 2604(e)), th e En viro nm enta l Protecti on Agency·("EPA "' or "th e Agc n cy"}issues th e a tt ac hed Orde r , re ga rdin g premanufacture notice s ("P MN s") for the ch em ical s ub stances P 15-59
-
P15
- 60- and P15-104- ("the Pr-.1N subs tances") su b mitted by Nanosys, In c . ("the Company"), t o t ake e ffect upon exp ira tion of the 

### PMN review p e riod s. The Co mp any s ubmitted the 

### P l'v1 Ns t o EPA pursuant to § 5(a)(l) ofTSCA and 40 CF R Part 720. Under§ 15 ofTSCA, it i s Lmlawful for any person t o fail or refuse to comp ly with any prov i sion of§ 5 or a ny orde r is s u e d und e r § 5. V i o lators may be s ubj ect t o vari o u s p e nalt!es and to bo th crimina l a nd c iv il liabi li ty pursuant t o§ 16 , and to spec ific enforceme nt a nd se izure pursuant to 

### § 17. In add iti o n , chemical substa n ces s u b ject to an Ord er i ss ued und e r§ 5 of TSCA, such as thi s one, . are s u bject to the§ 1 2(b) expo t1 n otice requirement.

11. 

### SU MMARY OF TERMS OF THE ORD ER Th e Co nsen t Order fo r the PMN s ub sta nc es requires th e Company to : (a) submit to EPA ce rtain testing with in t he tim e triggers of the testi ng section of the consent order; (b) provide per sona l pro tective equ ip ment t o it s workers to prevent dermal exposure;IV 

### (c) manufacture, proce ss and use P-15-59 o nl y as a down-converter for an optical filter for LEDs u sed i n displays and P-15
- 60 and P-15-1 04 as che mi cal**intermediat es~**  

### (d) manufacture, proce ss, or u se the PMN s ubstances only in a l iq uid formu lation; (d) distribute th e PMN substances on l y to a p erso n \Vho agrees to follow the same restrictions

. . 

### . (except the testing r equirements) and to not further di s tribute the 

### PMN substances unless they incorporate th e PMN substance into an artic le(film); (e) dispose of the PMN substa nc es only by incineration in a p ermi tted hazardous waste incinerator; and (f) 

### ma intain cer ta in records.



### III. CONTENTS O F PMN By s i gn in g this Order, the Company repres ents that 

### it has carefully reviewed this d ocument a nd ag ree s that all in formation herein that i s claimed as confidenti al by the Company is co n ectly identified w ithin brackets and that any information th at is no t bracketed is not c l ai me d as confidential. To make this doc um e nt ava i lab l e for pub li c v i ewing, 

### EPA w ill remove on l y the information contained · within th e bracke ts. Confiden ti al Business Information C l aims (Bracketed 

# in the Preamb l e and 

### Order): Chemica l Identi ty, Production Vo l ume, Manufacturing and P rocessing Information. Chemical Id en titv: Specific: Pl5-59

-
Pl5

- 60 ·
P l S-104
-v Generic: P 15-59
- Cadm ium selen id e zinc sulfide dodecanoic acid and amine in amino function a l
s ilicone fluid. P15-60
- Cadmium selen id e zinc su lfid e dodecano ic acid and amine. P 15-104
- Alkanoic acid, reaction products with
.cadmium selenide and**alk~~lamine.**



### . 

## . U se: 

### 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 1 2 -M onth Production Volume: Pl5-59- P15-60- 

### p 

### 1 5
- 104- Test Data Submitted w ith PMN: Physical-Chemical Properties. EPA Toxicity Characteri stic Leaching Procedme (TCLP), California Soluble Threshold L imit Concentration (STLC), Ca lifornia Total Threshold Limit Concentration (ITLC), a nd wipe surface samp l ing 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 environmenta l release of the PMN subs t ances, based on the inform atio n currently avail able to the Agency .
Human llealth Effects Summary: Toxicological Endpoints of Concern: EPA identified concerns for lung effects, kidney effects, and oncogenicity based on analo g y to re sp irable poorly soluble particulates (See ww\v.epa.gov /o pptintr / n ewchems/pubs/chemcat. htm) and the pres . ence of cadmium
.VI

Env ironmental Effects Summary:

. 

### . Organisms exposed to cadmium 

### in the e nvironment may also develop chronic effects from expos ure to cadmium. Exposure and E nviro nmenta l Re lease Summruy: Manufacture Use #S ites 1 . 1 Workers 

### 6 

### 3 (#/site) Exposure(days /ye ar) 

### 255 250
Dermal Exposure 

### 6 .7E + l 6.7E+l (mg/ d ay) Inhalation Exposw-e Negligib le Negligible ( m g/day) Releases Via incinerat ion V i a incineratio n (days/year) 

### 255 250
Ri s k to Workers and the env ironment: There is a potential risk to workers that are exposed to the PMN s ubstances
. Uncontrolled releases to the env ironmen t cou ld also result in risks to humans and other organisms.



### V. EPA'S**CONCLUS O~S**  

### OF LA \ .Yvii The followin g findin gs constitute th e ba sis of the Consent Order: (a) EPA is unable to dete rm ine the poten ti a l f o r human health effects and environmental e ffect s from e xp os ure ofh um ans and other orga ni s m s to the PMN s ub stances. EPA th erefore concludes, pur s uant t o 

### § S( e )(J )(A)( i) ofTSCA, that th e information available to the Agency i s in s uffi c ient to permit a reaso ned evaluation o f th e hwnan health and envi ronme nt a l ef fects of th e 

### PMN s ub s t ances . (b) In li ght of the potential risk to hum ans and o th e r organism s posed by the uncontroll e d manuf acture, processing, di s tribution in co nm1 erc e, u se, and disposa l ofthe PMN substances, EPA h as conc luded ; · pu rsuan t to§ 5(e)(l) (A)( ii)(l) ofTSCA, th a t u ncontrall ed manufact ure, pro cess in g, di s tribution in commerce , u se, a nd disposal of th e 

### PMN s ub s tance s may present an unreasonab le r i sk of injury to human health and the environment.



### VI. INFORMATION REQUIRED TO EVALUATE HUMAN 

### HEALTH AND ENV IRO NMEN TAL E FFECTS . Tri gge re d Testin g. Th e Order r equires the C ompany to submit the i nformation d esc rib ed in the Testin g s ection of thi s Order in accordru1ce with th e co nditi on s spec ifi ed in the Testin g section.Pe nd ed Testing. The following addit io n al inform a tion would be req uired to evaluate effects which m ay be cau se d 

### by the 

### PMN s ubs tances: I nf o rm a tion Metabolism and Pharmacokin e tic s Effects Toxico k i nc tic G uidel ines OPPTS 870.7485viii The Order does not require submiss ion of the above pended testing at any s p ec ifi ed time or production vo lume. Howeve r, the Order's restrictions on manufacture , processing, distribution in commerce, usc, and disposal of the PMN subs ta nces will remain in effect" unti l the Order i s modified or revoked by EPA based on submission of that or other re levant information.



### . . . 

### .

## CONSENT ORDER

I. SC OPE O F APPLICAB ILITY AN D EXEMPTIONS (a) Scope .**T~ e**  require m ent s of thi s**Or~ r**  a pply to a l l c o mm e rc ial
_

manuf ac turin g,**pro ce** **~,** di s tribution in comm e rce , u se a nd disp osa l of the ch emic a l s ub s tances 

### PJ 5
- 59-
P15- 60
- ;and 

### P
- l S-104
- ("t h e PMN
s ubstan ces " ) i n the U ni ted S t ates b y N anosys, In c . (" th e Compan y ") , ex c e pt to th e ex te nt th at th ose ac tiviti es are ex e mpte d by p a ragrap h (b).
( b) Exemptio n s . \1 an u fac turi n g, process in g, di s tri b uti o n i n comm e rce , u sc an d d is p osa l o f th e P MN s u bs ta n ces are exe mpt f ro m the re quir e m e nt s o f thi s Ord e r (except th e re qu ireme nt s in th e R eco rdkeep i ng and Su ccesso r Li a bilit y Upo n T r a n s f e r O f Co n se nt Order sec ti ons) onl y to th e extent th a t (1) th ese act iv i ties are c o nd uc ted in full compliance w ith a ll appl i cab l e requ ire m e n ts of th e fo ll ow in g e xempti o n s, a nd ( 2) such co mplian ce i s d oc um e nt ed by appropri a te rc c o rdkee pin g as r equi r ed i n the R eco rdk cepin g se cti o n o f thi s Ord e r.

### - 2
- ( 1) Export. Until the Company beg ins commer c i al manufactu re ofthc PMN s ubstan ces for use in the Un ited Stat. es, the requ irements of this Order do not app ly to manu f acture, processing
or dist r ibution in commerce ofthe PlvfN substances solely for ex p ort in accordance wi th TSCA 

### §§ l2(a) and 12(b), 40 CFR 720.3(s) and 40 CFR Par t' 707 . However, once the Company b eg i ns to mrmufacture a PMN substa nce for use in the United States, no furth er activi t y by the Company invo l v in g t h e P MN substa nce is exe mpt as "so le l y f o r ex p ort" eve n i f some amount ofthe P MN substance is later exp01ted. At that p oint, the requirements of th i s Order app ly to a ll activ i ties associated with the P.MN substance while in**th~** 

### teJ,Titory of the United Sta_tes. Prior to l eaving U.S. tenitory, even those quantities or batches of the PMN s ub stance that arc destined for export are subject to terms of the Order , and count toward s any p ro d uct io n volume test triggers 

### in the Testing section of th i s Order. (2) Re search & 

### Development ("R&D"). 

### The requirements of this Order do not apply to manufactur i ng, proc ess ing, di s tribution in commerce, use and disposal ofthc PM N substances in small quantities solely for research and development in accorda nce with TSCA §5(h)(3), 40 CFR 720.3(cc), and 40 CfR 720 . 36. The re qui remen t s of th is O rd e r a lso d o no t apply to ma n ufacturing, processing , distribution in commerce, use and disposal of the P MN substances when manufactu red
so lely f or non-commercial research and deve lopment per TSCA §S(i) and 40 CFR 720 . 30(i). (3) Bvproduct s. The requirements of this Order do not apply to the 

### PMN substances when they are produced , without separate commercial intent, on ly as a "byproduct" as defined at 40 CF R 720 . 3(d) and in compliance with 40 CfR 720.30(g). (4) No Separate Commercial Pul])os e. The req uirements ofthis Order do not apply to th e PMN substances when they arc manufactured, pursuant to any of the exempt i o n s in 40 CFR 720.30(h), witi1 no commercial purpose separate from the su bstance, mixture, or**articl~** 

### of which it

. .

### - 3 - is a p art. (5) Im ported A rticles
. The r equirements of thi s Order do not apply to the PMN s ub stances when they are imp o rt ed as part of an "a r ticl e" as defined a t 40 CfR 720 . 3(c) and in compliance

· wi th 40 C FR 720 . 22(b)( l).

(c) A utomati c S un se t. If the Co mpan y h as ob ta in ed f or a PMN substa nce a T est M arket Exe mption ( " TM E") un de r TSCA § 5(h)(l) a nd 40 CF R 720.38 or a Low Volume Exemp tion ("LYE") or Low Re lease and Expos ure Exemption ("LoREX") under TSCA §5(h)(4) and 40 C FR 723.50(c)(l) and (2) r especti vely
. any such exemp ti o n is automatica lly rendered null and void as of the effective d ate of thi s Consent O rder
.


### H. TERMS OF MANUFACTURE ON C LUDING IMPORT}, PROCESSING, DI ST IUB UTION I N C OMMERCE. USE. AND DI S P OSAL PENDI NG SUBMISSION AND E VALUATION OF I NFORMATIO N PROHIBITION The Company is prohibited f rom manufacturin g (defined by s t atut e to in c lude import) , proce ss ing, distributin g in commerce, u s in g, or disposing of the PMN subs t a nces in th e U nited State s , for any n o nexem pt commercial purpose , pending the development of information nec essary for a reasoned evaluation of the human health and env i ronmental effects of the substances, and th e complet io n of E PA's revi ew of, a nd regulatory ac ti o n based on, that information , except in accordance with the cond iti ons described in thi s Orde r.

### - 4
- TEST I NG (a) Section 8(e) Reporting. Reports of information on the PMN substances which reasonably supports the conclus ion that the PMN s ub s tan ces present a subs t an tial ri s k of injur y to health o r the environment and which' is requ i red to be r ep01icd· w1der TSCA sectio n 8(e)· shal l reference the appropriate PMN identificatio n number for th e substance and contai n a statement that the substance is subject to thi s Conse nt Ord er. Addi ti onal information regarding sec ti o n 8(e) reporting requirements can be found a t ·www.epa.gov /opptltsca8e.
(b) Notice of S tudv Sche duling. The Company sha ll notif y, in writin g, the EPA M o nito rin g Assistance and Media Programs Division (2227A), Office of Enforce m ent and Compliance Assurance , U.S. Environmenta l Protection Agency, 1 200 Pennsylvania Avenue , 

### N.W., Washington , D .C. 20460, of th e following in formatio n within 1 0 days of sched uling a ny s tu dy requ ired to l?e perfonned pursuant to th i s Order, or within 15 days after the effective date of this Order, wh i chever is l ater: ( 1) The date w he n the stud y is schedu led to co mm e nce; (2) The name and address of the l aboratory wh ich will co nduct the study; (3) The name and te lep h one numb e r of a person at th e Company**~r** th e laboratory whom EPA may contact regardi n g th e study; and, (4) The appropriate**P~v1N** identification number for each substance and a state ment that th e substance is subject to this Consent Order. The written n otic e s hould be s ubmi tted to E PA as fo ll ows: Posta l Mai l Address U.S. Environmental Protecti on Agency

### - 5
- GL P Sect ion Chief- Pesticides, Water and Taxies 13r anch Monitoring A ss i stance and Media Programs Divi s io n (2227 A) Offi ce of Enforce m e nt a nd Compli a n ce Assurance 1 200 Pennsylvan ia Avenue, N.W. Washington, D C 20460

Courier D e li ve ry Address U.S. Env ironmenta l Protection Agency GLP Section Chief

- Pe s ticid es, Wate r a nd Tax ies Branch Monitoring Assist ance and Media P r ograms Division (2227A) Office of Enforceme nt and Compliance Assurance R oo m 71 178 1 200 P e nns y lv ania Ave nue , N.W . Was hin gto n, DC 20004 · (c) Good Laborato ry P ractice Stand ards and Test Proto co ls. Each s tu dy in paragraph d (2) mu s t be conducted acco rdin g to T SCA Good Laboratory Practic e Standards at 40 CFR P a tt 792 and using
met hodo l og ies gen e ra ll y accep ted in the re levant sc ien t i fic commu nity at th e tim e th e study is initiated
. Before startin g to conduct any s tud y that w ill u se a modi fi ed vers ion of a pub li shed test gu ideline, the Company must subm it w ritt e n te st protoc ols to EPA for rev iew (subm i ssio n of wri tt en tes t pro toco ls is opt iona l fo r tests th a t arc to be conducted u sing unn10difi ed publ i shed te s t gu idelines). Protocols must be s ubmitted as a s upport d ocument for the P MN, u s ing the procedures set out in 40 Cf'R 720.40 . EPA w ill respond to the Company w ithin 4 weeks of

### - 6
- receiving th e written protocols. EPA r ev i ew of a test protocol do es not mean pre-acceptance of test r es ults.
(d) Triggered Testing Requ irements: (1) W i thin 3 mon ths o f signing th e Consent Order ·, t he
co mpany will provide the followi n g material characteri zation test data for P
- 1 5-59; (i) Using transmi ss ion e lec tron mi cros copy (prov id e im (_lges ), dry and liquid partic le s ize distr ibution/coun ting methods, c h aracter ize s i ze, s h ape, morphology, s urface area, particle size distribution, aggregation/agglomeration state. (ii) X-ray diffraction for t he presence of crystall in e ph ases. (iii) Surf ace chemistry ( includin g e l e me n ta l compos iti o n) by x-ray pho to electron spectroscopy. Description of the phy sica l-chemical propertie s of the m ater ial t este d should take into considera tion the character izations identified in the Guidance Manu a l for th e Testing of Manufactu red Nan omaterials: OECD's Sponso r sh ip Programme; First Revision, 2009 (ENV/JM/MONO 2009). (2) Within 

### 1 8 month s of s i g nin g the Consent Order th e C omp any s h all subm it to EPA the resu lt s of a study to measure release of P- 15-59 from th e article (film) which it i s incorporated into. Th is article is contained in · an elec tronic display device. Th e study protocol shall be d esigned to
emu l ate both the u sage of the article (film) inc o rporatin g P-15-59 duri ng 

### a 5- year cons umer usage in an e lectronic di sp lay device as well as the pote nti a l re lease of P-15- 59 from the article after use ( i. e, disposal in a l andfi ll). Cadmi um wi ll be measured to determ ine i fP-15-59 is re leased. T h e Co mpany and EPA s h a ll agree to a protocol fo r the study within six months of sign in g th e consent order.- 7
- An example study protocol reflecting the key concepts for th e study is shown below:
• Prepare test articl es (fil m) consistent with this consent orde r o tes t articles (film) initial ba se line tes tin g • Wipe test to determine amount o f cadmiu m on s urfa ce • Wash tes t with deionized water to determi n e amount of cadmi um that can be released from the s urfac e o test articles (film) use l ife aging s imulation test
• High inte n s i ty blue light expos ure (as used in product application) with 100 % humidity a nd 1 60 d egre es F temperature fo r 137 d ays • Collect a ll condensate and se nd samp le to lab for testin g once per month
o tes t artic l es (fi lm) after u se l ife ag in g simulation test
• Perform water imm e rs io n , TCLP, STLC, and TTLC test to determi ne avai lab l e cadm iu m , which wiU be used as an indicator of the amoun t ofP15-59 released during disposa l in a landfill.
o All measured cadmium amounts at the above n o te d t es t point s will b e re ported to 

### EPA (e) Test Reports . The Company shall: (1) conduct each study in good faith, with due c are, and in
a sc ie ntifi call y valid manner; (2) promptly furn i sh to EPA th e results of any inte r . irn phase o f each study; and (3) subm it the final report of each study (with an additional sanitized copy, if confiden ti a l bus in ess information i s in volved) and all und e rl ying data ("the report a nd data") to EPA prior to exceed in g th e app licabl e productio n limi t. The fin a l repo rt an d d a t a must be submitted a s a support document for th e PtvfN , u s ing the procedures set out in 40 

### CFR 720.40.

### - 8 - The final report shall co nt ain the contents spec ified in 40 CFR 792.185. Underlying da ta shall be submitted to EPA in accordance w ith the applicable "Rep orting," "Data and Reporting ," and "Test Report" subparagraphs in the applicable t es t guidelines. Ho wever, for purposes of thi s Consent Ord e r, the word "should" in those subpru·agraphs shall be interpreted to mean "shal l " to make clear that th e submission of such information is mandatory. EPA will require the submission of raw data such as slides and l aboratory noteb ooks only if EPA finds, on th e basis of professional judgment, that an adequate evaluati on of the study cannot take place in the absence of the se items. (i) Testing Waivers. The Company i s not required to conduct a study specified in paragraph (d) of this Testi ng section if notified in writing by EPA that it i s unnecessary to conduct that study.
(g) Equivocal Data. If EPA finds that the data generated by a study are scientifically equ ivocal , the Company may co ntinu e to manufactme th e PMN substance s beyond the applicable production limit. To seek relief from any o th er re strictions of this Order, the Company may make a second attempt to obtain unequivocal data by reconducting th e study under the condi ti ons speci fied in parag raphs (b), (c), and (c) (except that the s tudy may be sub mitted after reaching th e applicable production limit). The testing r e quirement s may be modified, as neces sary to permit a reason ed evaluation of th e risks pres ente d by the PMN su bst ru 1ce s, o nJ y by mutual consent of EPA and the Company.
(h) EPA Determination of lnvalid Data. (I) Except as describ ed in s ubp arag rap h (h)(2), 

### if, w ithin 6 weeks ofEPA's receipt of a te s t repo rt 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 b eyon d the applicable production limit only if so notified, in writin g, by EPA in respons e to the Company 's compliance with either of the following s ubparagraphs (h)(2)(i) or (h)(2)(ii). (i) If th ere is suffic ient tim e to reconduct the s tudy in compliance with paragraph s (b), (c), and (e) before exceeding the production limit specified in paragraph (d) , the Company may r eco nduct 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 p arag raph (d) , th e Co mpany may exceed the p roduction limit , but must otherwi se comply with parag raphs (b) , (c), and (e). and shall submit th e report and data to EPA within a reasonab l e period of time, all as specified by EPA in the notice described in sub paragraph (h)(l). E PA will respond to the Company, in writing, within 6 weeks of receivi n g the Company 's report and da ta. (ii) The · Company may, within 4 weeks of rec ei ving from E PA the n otice described in subparagraph (h)(l) , submit to EPA a wr itten repo rt ref utin g EPA's finding. EPA will re spond to the Company, in \IVfitin g, within 4 weeks of receiving th e Co mpany's repm1.
(i) Company Determinati o n of Invalid Data. (I) Exce pt as d escri bed in subparagraph (i)(2), if the Co mpany becomes aware that circums tances clearly beyond the control of th e Company o r l abo ratory \1\l}ll preve nt , or h ave prevented , development of sc ientifically valid da t a under the conditions specified in paragTaph s (c) and (e), th e Company remains prohibited from fm1her m anufactu re of the PMN subs tances be yo nd the appli cable production limit.

### - I 0
- (2) The Co mpany may submit to EPA, within 2 weeks of first becomin g aware of such
c ircumstances, a written statement explaining why circumstances clearly beyond th e control of th e Company or l aboratory will cause or have caused dev elop ment of scientifically invalid data. EPA 

### ,..,111 noti fy the Compa ny of its response, in writing, w ithin 4 weeks ofreceiving the Company's report. EPA's written respon se may either: 

### (i) allow the Company to conti nu e to manufacture the PlVIN substances beyond t h e applicab le production l imit , or (ii)**r~qu ir** **e** 

### the Company to co nt _i nue to conduct , or to reco!1duct, the s tud y in compliance with paragraphs (b), (c), and (e), 

### if there is suffic ient time to conduct or reconduct the study and submit the report and data to EPA before exceed in g the production limit s pecified in paragraph ( d). If there i s ins ufficient time for the Company to comply with paragraphs (b), (c), and (e) before exceed ing the production limit speci fied in paragraph (d), the Company may exceed th e production limit, but must otherwise comp l y w ith paragraphs (b), (c), and (e), and shall s ubmit the repo1t and data to EPA ·within a reasonab le period of time , all as speci fied by EPA in the notice described i n su bparagraph (i)(2). E PA w i ll respon d to th e Company, in writ ing, w i thin 6 weeks of receiving the Company's repo1t and data, as to whether the Company may . conti nue to manufacture beyond the applicable production limit. (j) 

### Unreaso n able Risk. EPA may notif · y th e Company in wri tin g that EPA find s th at th e data generated by a study
are sc i en tifically valid and unequivocal and indicate that, despite the terms of this Order, the PMN subs tances wil l o r m ay present a n unr easonab le risk of injury to hum an health or th e environment. EPA's notice m ay s pecify th at the Company undertake certain actions concerning further t est in g,- 11 - manufacture, processing , distr ibution, 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 n otice, the Company must cease all manufacture, processing, distribution , use and disposal of the PMN substances , unle ss eithe r : (1) wi thin 2 weeks from rece ipt 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 refutin g EPA's finding and/or th e ap propriateness of any addit ional requirements imposed by EPA. Th e Company may continue to m a nufacture , process , distribute, use and dispo se of the PMN substances in acco rdance with the te rms of this Ord er pending EPA's response to the Co mpany's wri tten re p ort. EPA will respond to th e Co mpany , in writin g, wi thin 4 weeks of receiving the Company's report . Within 2 ,• ,reeks of receipt of EPA 's written respo n se, the Co mpan y shall comply with any require m ents imp osed by E PA 's response or cease all· manufacture , pro cess in g, di st ri bution, u se a nd di s posal of the PMN subs t ances.
(k) Other Requiremen t s . Regardless of the sat is faction of any other cond iti ons in this Tes ting section, the Co mp any must continue to obey a ll the terms of thi s Consent O r der until otherwise
n ot ifi ed in writing by EPA. The Compa ny may , ba sed upon s ubmitted test data o r o t her relevant information , petiti o n EPA to modifY or revoke pro visio ns of thi s Consent Order pursuant to Part VI. of this Consent Order.- 12- 

### PROTECTION IN THE WORK PL ACE (a) Establ i shment of Prog ra m. During manufacturing, process in g, a nd use of th e PMN substances at any s ite cont rolled by the Company (includin g a ny associated p ackag in g a nd storage and during
a n y cleanin g o r m ai nte n a nce of equipm ent associated with
. th e PMN substance), th e Com p any must es tabli sh a program whereby: ( I) G e n eral D e rm al Protection. Each p erso n who i s reasonably li ke ly to be d ermall y exposed in th e w ork area to th e PMN substances through di rect hand l ing o f the substance or through contact with equ ipmen t on which the subs tanc e may exist i s r equired to wear, per so n al

.. 

### . 

## . . protective equipme nt th at provides a barri e r to prevent d erm al exposure to the s ub s tance in th e specific work area where it is selected for use. Eac h such item of personal protecti ve e quipme nt must be selec ted and u se d in acco rdan ce with O ccup ation a l Safe ty and H ea lth Administration ( " O SHA") derma l protec ti on req uirem e nt s a t 29 CF R 1 910 .1 32, 1 9 10.1 33, an d 19 1 0. 1 38. (2) Spec ifi c D em1a l Protect ive Equ ipment. The d e rmal protective e quipm e n t req u ired by subparagra ph (a)(l) o f this sect ion mu s t includ e , b ut is n o t limited to, th e f o ll ow ing items : (i) Glov es . (3) Demonstration of Imperviousness. The Company is able to demonstrate that each i tem of chemica l p ro tectiv e cl othin g se lected , includin g g loves, provides an imperv ious barrier to preven t derma l ex po s ure durin g nom1al an d expected dura tion a nd cond iti ons of expos ure w ithin the work area by any o n e or a comb ination of the following: (i) Permeation Test in g. Te s tin g the material u sed to make the chemical protect ive cloth ing and the const:r · uction of the cloth ing to es t ab li s h that the pro tective clot hin g will be impervious for the exp e c ted durat ion a n d co ndit ions of exposure. The testing must subject the
c h emical protecti ve clothing to the expected cond iti ons of exposu r e, includin g the l ikely- 13 -
co mbinations of c h em ical substances to which the clothing may be ex po sed in th e work ar ea. Permeation tes tin g shall be conducte d acco rdin g to the American Society for Testing a nd Mate rials (''ASTM '') F739 "S tandard Test Method for P e rme a ti o n of Liquid s and Gases thro u g h Prote ctive

. 

### . C l otliing Materials und er Cond it ions of Co ntinuou s Co nt act." R esults sha ll be r eporte d as th e cumu l at ive permeation rate as a funct i on of time, and s h a ll be documented i n acco rdanc e with ASTM F739 u s in g the format spec ifi ed in ASTM F1 1 94-99(20 1 0) "S tandard Guid e for Documenting the Results of C h emical Permeation T es tin g o f Mate ri als Used in Protective Clo thing Material s." Glove s may not be u sed for a tirn e per iod lon ger th a n they -a re actually tes ted
a nd must b e rep laced a t the en d of each work s hift during whic h th ey are exposed to 

### the P MN
s ub s tances. (ii) Man u factu re r 's Specifications. Evaluating th e specificat ions fi·om the manufac turer or s upplier of th e c hem ic a l protect ive clothing, or o f the materia l u se d in
co n s truct ion of the clothin g, to establ ish that the chemical protec tiv e clot hin g will b e imp e rvi ous to the PlvfN substances al one and in like ly combinati o n with o ther chemical s ub s t ances in th e work
ar

ea .
MANUFACTURING (a)(J) Proh ibi t ion. The Company sha ll not cause, encourage, or s u ggest the manufacture of th e PlvfN substa n ces by any othe r perso n . (2) Su n se t following SNUR. Subparagraph (a)( I) s hall exp ire 75 days after promu lgation of a fina l sign ifi cant n ew use rule ("SNUR") gove rnin g th e PMN subs tances under section 5(a)(2) of TSCA u nless the Company i s no ti fied o n or before that day of a n ac tio n in a Federal Court**scckingjud l**  r ev iew of th e**S~UR.** Jfthe Company i s so n otified, s ubparagraph (a)(l) shall not- 14-

ex pire until EPA notifies the Company in ·writing that all Federal Court actions in volving 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
s uoparagraph (a)(l) ex pires 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
ex i stence 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 Manufac turer. Notw ith sta nding parag raph (a), the Company may cause the Contract Manufacturer(s) identified in the Consent Order for Contract Manufacturer in Appendix C t o manufacture the PMN substances according to the following conditio n s (the Company may petition 

### EPA pursuant to Section 

### VI of this Order to include additional Con tract Manufactmers): 

### ( 1) The Cont act Manufacturer must be under contract to the Company to manufacture the PMN s ub s tances solely for th e Company. The contract mu st specify the identity of th e PMN
s ubstances, the total quantiti es to be manufactured, and th e basic techno logy to be used for manufacturing. (2) The Company shall obtain from each Contract Manufacturer a signed copy of the Co nsent Ord e r for Contract Manufacturer (attached to this Order as Attachment C) a nd submit the copy to EPA along with the name, address, and telephone numb e r of a r espo nsible official of th e Co ntract Manufac tu rer. The Con tr act Manufactur er or Company must receive a fully executed copy of the Conse nt Order for the Contract Manufacturer from EPA before the Contract Manufacturer may begin manuf acture .- 15- 

### (3) If at any tim e, the Compan y lea rn s t hat the Cont r act Manufa ct ure r has failed to comply with any of th e condit i ons specified in the Consent Order for Contract Manufacturer, the Company
s hall immediately cease to cause the Contract Manufacturer to manufacture the 

### Pl\1N substances, tin less the Contract Manufacturer is in complianc e vvith a SNUR for the P MN substances, or unless the Company is ab le to document each of the followin g : (i) That the Company ha s, within 

### 5 workin g days, notified the Contract M a nufacturer in writing that the Contract Manufacturer has failed to comply with the conditions spec ified in the Consent Order for Contract Manufacturer. (ii) That, within 

### IS workin g d ays of notifying the Contract Manufacturer of the noncompliance, the Company received fr om th e Contract Manufacturer, 

### in \¥riting, a statemen t of
ass urance that the Contract Manufacturer is aware of the tenns of the Consent Order for Contract Manufacturer and will comply with those term s. (iii) If , after receiving a stateme nt of assurance from the Contract Manufacturer under
s ubparagraph (B) of thi s Section, the Company has n otice or knowledge that t he Co ntract Manufactm-e r has failed t o comp l y wi th any of t he conditi ons spec ifi ed in t he Co n sent Orde r fo r Co ntract Manufacturer, the Company shall immediately cease to ca u se the Contrac t Manufacturer to manufacture th e Pl'v1N subs tance s, sha ll notify EPA o f the failure to comply, and sha ll resume causing the Contract Manufa c tur e r to manufacture the PMN substances only upon written no tification from the A ge ncy (b) Th e Co mp any shall manufacture, process, or u se the PMN substances only in a liquid fo nnulation. (c) The Company s h all manufacture, process and use P-lS

- 59 on ly as a down-converter for an optical filter for LEO s used in displays and P
- 1 5-60 and P-15-1 04 o nly as chemical intennedi ates.- 1 6 -



### DI STR II3UTJON (a) Export No ti ce Req ui reme nt. N o later than t he d ate of d i stri b uti o n , the Co m pany shall n oti fy in

. writing any person to wnom it distributes the P MN substances that, due to the i ssuance of this

Consent Order under section 5(e) of T SCA, the P:t-.1N substances are s ubject to the export
n otificatio n req ui re me nts ofTSCA sec ti o n 1 2(b ) a nd 4 0 CPR P art 7 07 S ubpart 0 . S u c h no ti ce shall contain, in the fonn in wh ich i t app ears in th i s Co nsent Order , the following infom1 ation: ( 1)**th~** PMN number, and (2) eit he r (A) th e specific chemic;al identi ty of the P :t-.1N**~stances,** or (B) 

### if the spec i fic c he mi ca l id entity is co nfid e ntia l , th e ge n eric c h e mi cal i de ntity . (b) Distribution Requirements. Except as provided in paragrap h (c), the Company shall distrib u te t h e P MN substa nc es o u tside th e Co m pan y , oth e r t h an fo r di sposal, o nl y t o a perso n w h o h as agreed in writing prior to the date of d i str i bu tio n , to : ( 1 ) Notify in writing any perso n to whom it d i stri butes t he PMN subs t ances that, due to the i ssuance of th is Co n se nt O r der w1 dc r sec ti o n 5(e) of T SCA, th e PMN s ub stan ces are sub j ect t o th e export notification requirements ofTSCA section 12(b) and 40 CF R Part 707 Subpart D. Such notic e s h a ll contain, in the form in which it a ppears in this Consent Order, the following information: ( 1 ) the PMN numbe r , an d (2) e i the r (A) th e spec i fic c h e mi ca l i de ntity o f the P MN substance, o r (B) if the specific chemi ca l id e ntity i s confidential , the generic chemical i denti ty. (2) Not further di s tribute th e PMN substance to any other person, othe r than for dispos al, unti l afte r th e PMN substance has bee n incorporated i nto a n arti c le (fil m ). (3) Comply with th e sa me requ irem e nts and restrictions , if any, required of the Company in the Pro tection in t h e Workplace.- I 7- (4) Comply with the same environmental rele ase res triction s, if any, required of.the Company in th e Disposa l section of thi s Order. (5) Not u se P-15-59 other than as a d own-converter for an op t ical filt e r for LED s u se d in displays , use P -15-60 or P-15-104 as chemic a l iJ 1termediates or u se any of the PMN substances in the form of a so lid.
(c) T emporary Transport and Storage. Not\vithstanding paragraph (b) , th e Comp a ny may d is tribut e the PMN substances outside the Company for temporar y tran spo rt and storag e in sealed
co ntainers prov id ed the fo ll ow ing three condition s are m et: ( l ) Subsequent to any suc h exe mpt temporary transport or storage of sea le d containers, the PMN substances may be distributed only to the Company or a p e rso n who has g iven the Company th e written agreement r eq uired b y paragr aph (b)
. (2) A ny hum a n exposure o r environme ntal rel ease resultin g fro m opening the sealed containers and remov in g or was hi ng out th e PMN substances may occur only whi le the PMN
s ubst a nces is in the possession an d control of the Company or a person who ha s given th e Company th e written agree m en t requ ired by p arag raph (b).
(d) Recipient Non-Comp li ance . If , at any time afte r commencing distribution in commerc e of the PMN substances , the Company obtain s knowledge that a reci pi en t of the subs tanc e ha s fail ed to
co mp ly with any of the co nd iti o n s s p ec ifi ed in paragraph (b) ofthis D istributio n section or, after subparagraph (b)(2) exp i res in acco rd a nc e ·with s ubpara g rap h (e)(l), h as engage d in a s ignifi cant · new use of the PMN substances (as defined in 40 CF R Part 72 1 , Subpart E) w ithout s ubmitting a sign ifi can t new us e notice to EPA, th e Company s hall**~ease** supp l y in g the substan ce to tha t**~** 18 - recipient , unless the Company is able to document each of th e following: 

### (1) That the Company has, within 5 working days, notified the recipient i n writing that the recipient h as failed to comply with any of t he conditions spec i fi e d in paragraph (b) of this D i stribution sect ion; or has e n gage d 

### in a significant new use of tl1e PMN substances without submitting a significant new u se notice to EPA. (2) That , w ithin 15 workin g days of notifying the rec ipient of the noncompl i ance, the Company received from th e recipient, in writing, a statement of assurance tha t t he recipient is
aware of th e terms of paragraph (b) ofthis Distribution section and will comply with those terms , or is aware of the te rms of the s i g ni fican t new use rule for the PMN su b stances a n d wi ll no t engage in a significan t new use wi th o ut submitting a significant n ew u se notice to E P A. (3) If, after r eceiving a statement of assurance from a rec ipient under subparagraph (d )(2) of th is Di s tribution section, the Company obtai n s knowledge tha t the r ec i pient h as failed to comply
w ith any of the conditions specified i n paragrap h (b) of this Distribution section, or has engag ed in
a significant n ew use of th e PMN substances without submitting a significant new u se notice to E PA , the Co mpany shall cease supp lying the PMN substances to that recipient, s haJI n otify EPA of the failure to compl y, and shall resume supplying the PMN s ub s tances to th a t recipient only up on**\~ Titten**  notification from the Agency.

(e) Sunset Following SNUR. (1) Subparagraph (b)(2) ofthis Distribution section sha JJ expire 75 days after promulgation of a final SNUR for the PMN substances u nder secti on 5(a)(2) of TSCA , un l ess th e Co mpany is notifi e d on or b efore that day of an ac ti on in a Federal Cou rt seeking judicial review of the SNUR. Jfthc Company is so notified , subparag raph (b)(2) of this- 19 - Distr ibu ti on section shall not expi r e until EPA n o tifi es the Company in writing that all Fed eral Cow-t actions inv olv in g the SNUR have been re so lved and the val idit y of the SNU R affirmed. (2) Wh en EPA promulgates a final SNUR for the PMN su b sta nc es and sub paragraph (b)(2) of this Distrib utio n sectio'n expires in acco rdan ce v ,ii th subparagrap h (e)(J ) , the Company shall n ot if y each p erson to w h om it distributes tbe PMN subst ances ofthe ex iste nce of the SNU R. Suc h n o tifi cation
m u st be in writing and must speci fi call y includ e all limit atio n s contained in the SNUR wh ich are defined as significant new u ses, and which would invok e s i gnificant n ew u se notifi ca ti o n 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 Co de of Federal Regulations. After promulgation of a SNUR a nd exp ir ation
.of s ubp aragr ap h (b)(2), such noti ce ma y substitute for the writte n ag reement r equired i n th e introductory cla u se ofpru·agraph (b); so that, if the Company provides suc h notice to the perso n s to w ho m i t distributes the PMN s ubs tances, th e n th e Company is not req uir ed to obtain from such perso n s the written agreemen t spec ified in paragraph (b).

DISPOSAL The Company shall dispose of the PMN s ubstru1ces and any waste stream con taining the PMN sub s tance s only as follows. This prov ision does not supersede or preempt ru1y applicable federal, state, ru1d local laws and regul a tions if th ose laws are more strin gent than t he r equ irements be low. (1) The PMN substances must be disposed of on ly by incin e rat io n in a permitted ha zardous was t e in cinerator.- 20
- · 

### III. RECORDKEEP I NG (a) Records. The Company sha ll maintain the followin g records until 5 years after ti1e date they
are created and s hall make t hem available for inspection and copying by EPA in accordance with section II ofTS'CA: (1) Exemptions. Record s documenting that th e 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 recordkeep i ng requirem e nts applicable to Hie
exe mption being c laimed 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 Reco rdkeeping section, if the Company maintains, for 5 years from the date of their creation, copies of the export labe l and export notice to EPA, required by TSCA sect i ons 12(a)(l )(B) and 12(b) , respective ly. Any amounts or batches of the PMN su bstance s e li g ible for U1e research and development exemption in Section I , Paragraph (b)(2) of this Order
are exemp t from all the requirements in this Recordkeeping section, if the Company maintains, for 5 yea rs from the date of their creation , the records required by 40 CFR 720 .78(b)
. For any amounts o r batches of the PMN substances claimed to b e eligible for any other exe mption described in Section I, Paragrap h (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 , b ut is exe mpt f rom the other recordkeeping requirements in this Recordkeeping section; (2) R ecords documenting the manufacture volume of the PMN substances and the corresponding dates of manufacture; (3) Records documenting the nam es and addresses (including shipment de s tination address, if different) of all perso ns outside the site of m a nufacture to whom th e Company directly- 21 - 

### sel ls or transfers th e PMN substances, the date of each sa le or transfer, and the quantity of the substance sold o r transferred on such date; ( 4) Records documenting the address of all s ite s of manufacture, processing, a nd u se; (5) Records documenting establishment and implementati'on of a program for the u se of any appl icable personal pro tective equipment required pursuant to the Protection in the Workplace sectio n ofthis Order; (6) Records documenting co mplian ce with any applicable manufacturing, proc ess ing , 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 comp li ance w ith a ny applicable disposal requirements under the D i s p osal section of this Order, including method of disposal, l ocation of disposal sites, dates of disposal, and volume ofPMN s ub s tances disposed. Where the es timated disposal vo lum e i s not known to the Company and i s not reasonably ascertainable by the Company, the Company must maintain other records which demonstrate estab li shment and implementation of a program that
ensures comp li ance with any applicable disposal requirements; (8) Copies of any Transfe r Documents and notices required by the Successor Liability
s ection of thi s Order , i f appl icab le; and , (9) The Company shall keep a copy of this Order at each of its sites where the PMN
s ubstances are manufactured.

### - 22- (b) Applicability. The provisions of this Recordkcepi ng Section are applicable o nly to activities of the Company and it s Contra ct Manufacturer, if applicable, and not to ac tiviti es ofthe Company's customers.
(c) OMB Control Number. Under the P ap e rwork Reduction Act and its regulations at 5 CFR Part 1 320, particulady 5 CFR 1 320.5(b), the Company i s not requi red to respo nd to thi s "collection of information" unless this Order displays a currently vali d control number from the Office of Management a nd Budget ("OMB"), . and EPA so info rm s the C.ompany . The "co llection qf information" required in this TSCA §5(e) Consent Order has been approved under currently valid OMB Contro l Number 2070-0012.



### lV . REQUESTS FOR PRE-I NS PECTION INFORMAT ION (a) EPA's Request for Infom1ation. Pursuant to section 11 ofTSCA and 40 CF R 720.122, E PA may occasionally co ndu ct o n- s ite compliance inspections of Company facilities and conveyances associated w ith the PMN substances. To facil it ate such inspections , EPA personnel may contact the Company in advance to request infom1ation pe rtin ent 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 date s and times when the PMN s ubstances will be in production within th e subseque nt 12 month s; (2) Current workshift schedules for workers who are involved in activities associated with the PMN substances and may reason ably be expose d to the PMN su b stances;

. 

### .- 23- (3) CtuTcnt job titles or categories for workers who are involved in activities assoc iated 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 tim e, but in no event later than 30 days after receiving EPA's request. When requested in writing by EPA, the Company's response s hall be in writing. To the extent the inf ormation is known to or rea so nably ascertainable by the Company at the time of the request, the Company's
re s pon se s hall demonstrate a good faith effort to provide rea sonably accurate and d etailed an swe rs to a ll of EPA's requests.
(c) Confidential Business Informat i on. Any Confidential Business Information ("CB I " ) 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. SUCCESSO R LIABILITY UPON TRANSFER OF CONSENT ORDER (a) Scope. This section sets forth the procedures by wh ich the Company's ri g hts and obligations tmd e r thi s 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 D ate to Notice of Comme nc ement {"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 In te re st must submit a new. PMN to EPA and comply
_ fu ll y 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 Inte res t 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 Liabil i ty section of the Order: · (1) 

### "S u ccessor in Interest" means a perso n outside the Company w ho has acquired the Company's full interest in the rights to manufacture the PMN substances, includin g all ownership rights and legal liabilities, through a transfer doc u ment signed by the Company, as transfe ror, and the Successor in Interest, as transferee. The term exc ludes persons who acqu ire l ess than the full interest of the Company in the PMN substances, such as a li censee who has acquired a limi ted license to the patent or manufacturing rights associated w ith 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 Do cume nt" means the legal in s trum ent(s)**us~d** to co n v e y**th~** i nte rests in th e PMN s ubstanc es, in c ludin g the ri g ht to m a nuf ac ture th e PMN s ubstance s, from the Company to the Successo r in Interes t.
(d ) No tices. (1) Notic e to S u ccessor i n Inte rest. On or befo re th e effec ti ve date of the transfer , the Co mpany shall provide to the Successor in Interest, by registered m ai l , a copy of the Consent Order a nd the "Noti ce of Transfer" d ocumen t whic h is in co rporated b y ref ere n ce as Attaclunent B to thi s Order. (2) Noti c e to E PA. Wi th in 10 business d ays of the effective da te of the t ransfer, th e Co mpany s h all, by reg iste r e d m a il , submi t th e fu ll y executed Notice of Tran sfe r document to: The \vritten n otice s h ou ld be su bmitted to EPA as follow s : Postal Mail Address U .S . Environmental Protection Agency New Che' mica ls Ma n agement Bra nch (7405M) 1200 Peru1 sy lvani a A v e nue, N . W . Washin gton, D.C. 20460

Courier D e liverv Ad dre ss U . S. Envirorunenta l Pro t ec tion Agency New C he mi cal s Management Branch (7405M) 1201 Con s titution Ave nu e , N.W. Washington , D. C . 2 0004

### -26- (3) Transfer Document. Copies of the Transfer Document must be maintained by the Successor in Interest at its principal pl ace of business, and at all sites where the PMN substances
are manufactured. Cop ies of the Transf er Document must a lso be made avai lable for in spection pursuant to Section 1 1 ofTSCA, must state the effective date of tran sfer, and must contain provisions which expressly tran sfer liability for the PMN substances und er the terms of this Order from the Company to the Successor in Interest.

. (e) Li abi li tv. (1) The Company shall be liable for compliance with the requirements of this Order u nti l th e effective date of the transfer describ ed above
. (2) The Successor in In teres t shall be liable for compliance with the r e quirements of this Order effec tiv e as ofthe date of transfer
. (3) Nothing in this sec tion shall be construed to prohibit the Agency from taking enforcement action against the Company after the effective date of th e transfer for actions taken, or omissions made, during the time in which the Company manufactured, processed, us e d, di st ributed in commerce, or disposed of the PMN substances pursuant to the term s of this Con. sent Order.
(f) Obligations to Submit Test Data und er Consen t Order. If paragraph (d) of the Testing section of this Consent Order requires the Company to submi t test data to EPA at a s p ecified production volume ("test trigger''), the aggregate vo hun e of the PMN ·substances manufactured by the Company up · to the date of transfer s h a ll count towards the test trigger applicable to the Successor in Interesl.

### - 27
- VI. MODIFICATION AND REVOCATION OF CONSENT ORDER The Company may petition EPA at any time, b ased upon new information on the human health or env ironmental effects of, or h uman exposure to or env ironmental release of, the PMN substances, to modify or revoke substant ive provisioris of this Order
. The expo.s ure s and ri sks identified by EPA during its review ofthe PMN subs t ances and th e information EPA determined to be necessary to evalu ate those exposures and risks are de scribed in the preamble to this Order. However, in determining whether to amend or revoke this Order, EPA will consider all relevant information avai lable at the time the Agency makes**th~t** detenn.ination, including, where
. appropriate, any reassessmentofthe test data or other in formati on that supports the findings in this Order, an exami n ation of n ew test data or other information or ana l ys i s, and any other relevant information
. EPA will i ssue a modification o r revocation if EPA determines that the ac tiviti es 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 re asoned evaluation of the health or envi ronm ental effects of the PivfN substances. 

### In addition, the Company may petition EPA at any time to make other modifications to the la nguage ofthis Order. EPA w ill i ssue such a modification if EPA determines that the modification is useful , appropriate, and cons i stent with the structure and intent of this Order as i s sued.

### - 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 t han 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 co nclu sions underlying the Agency's determinations in this proceeding. This waiver does not affect any. othe r rights that the Company may have under TSCA.
(b) 

### CBI Brackets. By sign ing this Order, the Company represent s that it has carefully reviewed this document and hereby agrees that all inform ation herein that i s claimed as confidential by the Co mpan y (per section J4 

### ofTSCA, 40 

### CFR Part 720 

### Subprut E, 

### and 40 CFR Part 2) 

### is correctly identified within brackets and that any infom1ation th at is not bracketed is not claimed as 

### confidential. To make this document available for public viewing, E PA will**remov~** 

### only the information contained within the brackets. 

# )5

Date Maria J. Doa , P 1 ., 

### Director Chem ical Control Division Office ofPollution Prevention and Toxics

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

### Nru1osys, Inc

### ATTACHMENT A DEFINIT I ONS 

### [Note: The affached Order may not conta i n some of th e t erms defined below.]



### . . "Chemica l nam e" means the scientific designation of a chemical s ubstance in accordance Mth the nomenclature sys tem developed by the Chemical Abstracts Service's rules of nomenc lature, or a name wh ich will clearly identif · y a chemical substance for the purpose of conductin g a hazard evaluation. "Chemical protective clothing" means items of clothing that provide a protective bruTier to prevent dermal contact with chemical s ub stances 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 f o this Order. "Commercial use" m eans the use of a chemical substance or any mixture containif!g the chemical substance in a commercial enterprise providing sa leable goods or a service to consumers (e . g . , a commercial dry cleaning establishment or painting contractor). "Common name" means any designation or identi fication such as code name , code number , trade name, brand
. name, or generic chemica l name used to i dentify a chemical substance other than by its chemica l name. "Consumer" m eans a private individual who uses a chemical substance or any product containing the chem ical 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 chemic al substance that i s directly, or as part of a mixture, sold or made avai !able to consumers for the ir use in or around a permanent or temporary household or residence, in o r around a school, or in recreation. "Container" means any bag , barrel, bottle, box, can, cylinder, drum, reaction vessel, storage t ank, or the like that contains a hazardous chemical. Fo r ptuv oscs of this section, pipes or piping systems, ru1d engines, fuel tanks, or other operat ing systems in a vehicle, are not considered to be containers. "Contract Manufacturer" means a person, ou ts ide the Company, who i s a uth orized to manufacture the PMN substance under the cond ition s specified in Pru1 II . of this Cons e nt Orde r ru1d in th e Consent O rder for Contract Manufacturer. "Ident ity" means ru1y chemical or common name u sed to identify a chemical substance or a mixture containing that subs t ance.2 

### "Immediate u se." A chemical substance i s for the "immediate use" of a person if it is und er the control of, and us ed only by, the per son who tr a n sfe rred it from a l abeled con tainer and will on ly be used by that p erson within the work sh ift in which it is tran sfe rr ed fro m th e labeled container.

' :Imperviou s." Che mic al protectiv e cloth i ng is " impervious " to a chem i cal substance if the subs tance cau ses no chemical or mechanical de.gradation, permeation, or p e netration of the chem ical protective cloth in g under the conditions of , and the duration of , exposure . "ManufactuJing strean1'' means all r easo n ab l y anticipated tr ansfer, flow , or disposal of a chemical substance , regardless of phys i cal state or concentration, through al l intended operations of manufacture , in clu din g the cleaning of equ ipmen t. "MSDS" m ea n s m aterial safety data sheet, the written l isting of data for the chemical subs tance. "NIOSH" m e an s the National Institute for Occupational Safety and Health of the U.S. Depru1ment of H ealth and Human Services . "Non-enclosed process" means any eq uipm e nt system (such as an op e n-top reactor , storage t ank , or mixin g ves se l) i n which a chemical s ub s ta nc e is manufactured, proc esse d , or otherwise u sed whe re significant direct contact of th e bulk c he mical substance and t h e workplace air may occ ur. "N on-indu st ri al usc" m eans use other tl1 an at a facility w h ere c hemica l subs tances or mixtures are manufactured or processed
. "PMN s ub s tan ces" means the chemical substances described in the Prcmanufacture notice s ubmitted by th e Company relevant to thi s Ord e r.

" Perso n a l protec tiv e eq uipment " mean s any c he mic a l protective clothing or device placed o n the body to prevent co nt act with , and expos ur e to, an identified chemical su b s tance or substru1ces in tl1 e work a rea. Examples includ e, but are not limited to , c h em ical prot ective clothing, aprons, hoods, chem i ca l goggles, face sp las h sh ields , o r equivalent eye pro tection, and vru·io u s types of resp irators . Banier creams are not included in this definiti on .

" Proce ss s trea m " m ean s a ll reasonably an ti Qi pated transfer, flow, or di s po sa l of a ch emical su bs tance, regard less of phy s ica l state or concentrati o n , tllJou g h all intended operations of processing, includin g th e clean in g of equipment. "Scie ntifically in vali d " means any s i gn ifi cant departure fro m th e EPA
- reviewed protocol or the Good Lab o ratory Practice Standard s at 40 CF R Part 792 without pri o r or subsequent Agency review that prevents a reasoned evalu at ion o f the health or environmen tal effects oft h e P MN subs tance.3 "Scientifi ca ll y equivoca l data" means data whic h , a lth ough developed in apparent confom1 it y with the Good Laboratory Pr actice Standards and EPA-rev iewed protocols, are in conclusive, intemally inconsis ten t , or otherw i se insuffic ient to perm it a r easoned evaluation of the pote ntial risk of injUJy to human health or the env ironment of the PMN substance
. "Sealed container " m eans a clos ed container that is physically a nd chemically sui tab le for l ong -te rm conta inni en t of the 

### Plv1N s ub stance , and from which th e re will be n o human exposure 

### io , n or env iron men tal release of, the PMN substance durin g tran spo 11 and s tor age . "Use s tre a m" m eans a ll reaso n .a

bly antic ip ated tra n sfer, flow , o r di s p os al of a chemical s ub s t a nce , rega rdl ess of phys ical s tate or conc e ntr a ti on, throu gh all intended op erations of industria l , co mm e r c ia l , or consumer us e. "Wate rs of the Unit ed States" ha s th e m ea nin g se t forth in 40 C FR 1 22 .2. "Wo rk area" means a room o r defined space in a workpl ace where the P MN su b stance i s manufactured, processed, or used a nd where em pl oyees arc present. "Workplace" means an es t ablishment at one geograph ic location containing one or more work area s .

### Company (Transferor) 

### A TTAC HM ENT B NOT I CE O F TRANSFER OF T O XI C SU B S T AN C E S C O NTROL AC T S E C TI ON S(c) C O NSENT ORD E R

PMN Number 1. Transfer of Manufacture Rig hts. Effective on . the Company did sell or otherwise transfer 

# to , ("Succ esso r 

### in Interest") the rights and l iabi l ities associated with manufac t ure of the above-refe r enced c hemical substance, w hi c h was the subject of a preman u f ac ture n otice ("PMN'') an d i s gove m ed by a Conse nt Ord er i ssue d by th e U.S. Environmenta l Protection Agency ("EPA") un de r th e auth o r ity of §5(e) of the " Tox i c Substances Contro l Act ("TSCA," 15 U.S.C. §2604(c)). 2. Ass u mption ofLiab ility . The S u ccesso r in Inte res t he reby ce r 1ifies th at , as o f the e ff ec tiv e date of transfer , all actions or omissio n s governed by the app li cable Con se nt Order limiting manufacture, processing, use , distribu tion in conunerce and dispo sa l of the PMN substance, shall be the respon s ibility of the Successor in Interes t. Successor in Inter es t also certifi es th at i t i s i ncorporated, licensed, or doing business in th e Un i ted States in accordance w it h 40 CFR 720.22(a)(3). 3. Confidential Business Information
. T h e Successor in Interest hereby :

_ reassert s,

_ relinqui s hes, or mod ifi es aJJ 

### Confident ia l Business Inf ormation ("CI3I") claims made by th e 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 app l y to all such c laims
. Where "mod ifies" is indicated, such modification shall be expla ined in deta il in an attachment to this No ti ce of Transfer. Inf ormation whi c h has been previously disclosed to the public (e . g., a chemical identi ty that was not claimed as CBI by the original s ubmitter) wou ld not subseq uently be el igible for confidential treatment under this Notice of T ransfer.11 

### NOTI CE O F T RANSFE R OF T O XIC SU B ST ANCES CONT R O L ACT SEC TIO N S (e) CO NSEN T O RDER (co ntinu ed ) Co mp a ny**r~ ro** **)** PMN N umb er . Signature of Auth orized O fficia l D ate Printed Name of Authorize d O fficia l
Title o f A ut h or ized Official



### S u ccess o r in Inte r est



## - S ig n a ture o f Auth o rized Official D a te Print ed N a me· of Au thorized Offic ial
T itl e o f Authorized Offic i al Address 

### C ity, State, Z ip Co d eIll


### NOT IC E OF TRANSFER OF TOXIC SUBSTANCES CONTROL ACT SECTION S(e) CONSENT ORDER (continued)
Successor's Technical Contact
Address City, State, Zip Code Phone