Contains Confide nti al Business In formation (CBI) Date: June I 

### sa, 2015 J eff Bauer Progra m Manage r United States E nv ironme ntal Protection Agency Washingto n D. C. 20460 Re: PMtLP

- 15

- 328
Dear Mr
. Bauer,

and 1 am the
ac kn ow l edge the receipt of th e enclosed Co n sent O r der, and have signed the document where appropriate o n behalf of the company. - has retained th' e additio n a l copy of the Co n se nt Order at our New York office for

### fu**rstan din** **g,** and co mpl i ance. Jfthe EPA has a n y questions o r concerns, pl ease fee l fre e to contac t us. We understand the Consent Order is effective w h e n received by EPA. We l ook forward to th e EPA's confi rm ation of the document' s receipt. Thank yo u very mu c h for y our considerat ion
.

S i ncerely,

### UNITED STA'fES ENVIRONMENTAL PROTE C TION AGENCY OFFICE OF POLLUTION PREVENTIO N AND TOXICS REGULATION OF A NEW CH EM ICAL SUBSTANCE PENDING DEVELOPMENT OF INFORMATION

T n the matter of: ) Premanufacture Notice Numbe r: ) ) ) ) ) ) P-1 5-328 ) ) ) ) )

Consen t Order and Determinations Support i ng Consent Order

### .. ll


### TABLE Of**CONTE~TS** 

### Preamble l. 

### Introduc ti on Jl. 

### Summary ofTenns of th e Order 

### II I. 

### Conten ts of 

### PM N IV. 

### E PA 's Assessment o f Expos ure and R i s k V. 

### EPA's Concl u s i ons of Law 

### VI. Jnfo
. rmat ion Req uir ed to Eva ll}. ate Human 

### I Iealth and**t:~ ironm** **ental** 

### Effects

Co n sent Order I. 

### Scope o f App li c ab ilit y and Exemptions II. Terms of Manufac ture, P r ocess in g, Di st ribution in Commerce
. Use
. and Disposa l Pending Submission and Eva luat ion of Inf ormat ion TIL Recordkeeping IV. R equests for Pre-Inspection I nformation V. Successor Liab i lity Upo n T ran sfer of Consent Order VI. Modification and Re voca tion of Conse nt Order VII
. Effect of Consen t Or der
Attachment 1\ - 

### D efi niti on s Attachment B

-**~otice** 

### of Transfe r of Consent OrderIll 

## PR EA MBL E
I. I NTR OD UC T I ON Unde r th e a uth o rit y of§ S(e) of the Toxic Subs t ances Co n tro l Ac t ("TSCA'') (J 5 U
. S.C
. 2604( c)), the Enviro nm e nt a l Prot ec ti o n A ge ncy ("EPA" o r "the Agency") issues the attac h e d Order, regarding prcmanufactu r c notic e (' 'PMN ") P-15-328 for the c h e mic al s ub stance [ (" the PMN s ub stance'') s ubm itted by (" th e Co mp a ny "), to take effect upon expirati o n of th e 

### PM N review pe r iod
. T he Company
s ubmitt e d the PMN to EPA pursuant to§ S(a)(l) of TS CA a nd 40 CFR P a rt 720
. U nd er§ 1 5 ofTSCA, it is unlawful for any person t o fa il or refuse to comply with any provision of§ 5 o r any o rder issue d under§ 5. Vio lato rs may be s ub ject to various penalties and to both c ri min al and civ il liab ilit y pu r sua ntt o 

### § 16. a nd t o speci fi c enforce ment and seiz ure pu rsua nt t o§ 1 7. 

### ln addi ti o n , c he m ica l s ub stances s uhj ec t to 

### an Order is s ued und er § 5 of TSCA, s uch as thi s o ne, are s ubj ect to th e§ 12(b) export notice r eq ui re m ent.

TJ . SUMMARY OF TERM S OF THE ORDER The Co n se nt Order for th is PMN s ub stance requir es lh e Compa ny to: (a) p rov id e respirators to it s workers to prevent inh a lat i on exposure; (b) as a n alte rnat ive to u sing respira t ors, maintain workpl ace airborne concentrati ons of the 

### PJ\IIN s ub sta nce at o r below a specified**~ew** Chem ical Exposure Limit ("NCEL") of 

### 5 mg/m 3 , ver ifi ed by actua l exposure mon it oring data (to purs ue th is opt i o n , a sam p ling and ana lytic a l method mu st b e developed by the Company
. verified by an independent third-party laboratory , and**sub mitt~d**  to EPA ); 

### (c) Not use the 

### PMN $Ubstan ce other than 

### as an a ndI V (c) maintain cert ain records. III. C O NT EN T S OF P MN 

### I3y s igning this Order, the Compa ny represe nt s th at it ha s carefully reviewed t his d oc u ment a nd agrees that all information herein that is cla imed as confidentia l by the Co mpany is co rrect ly identi lied withi n brackets and that any in format ion that 

### i s not bracke ted is not c laim ed 

### as co nfidential. To make this documen t availab le for pub lic viewing
. EPA w ill remove on ly the information contained within the b rackets. Confide n tial Business In formation Cla im s (Bracke t ed in the P reamh lc a nd Order): S u bmitt er identity , c hemica l name , produc t ion volume, spec ifi c u sc, worker a 1 1d e nv ir onmental exposu r es . Chemical Ident it y:**Spccifi~:** Gl:ncric: Aluminum ca lc ium ox ide salt Us
. c: Specific: Generic: Cemen t additive Maximum 12- Month Production Volume: Test D ata S u bmitt ed with PMN: None

IV. E P A'S ASSESSMENT OF EXPOSURE AND n J SK The following arc EPA's predictio n s r egard in g t he probable hu man tox icity and hum an exposure of the · 

### PMN s ub s tance, based on the in fo rm ati o n c une nt l y available to 

### the Agency. Human H ea lth Effects Summary: Absorption: Absorpt io n i s nil a ll routes based on phys i cal/c he mi cal properties. Th ere is co n cern for lung toxicity based on lu ng overload from poorly soluble respirable parti c ul a t es.v To xicological End point s of Concern : There is concern fo r lu ng tox i c it y based on lung overload from poo rl y sol ubh.: respirab le particu l ates . Ba s is: Poo rl y soluble resp ir ab l e particulates See wv.w.epa.gov /opplintr / n ewche ms/pub s/c hem ca t.htm
Expo s ur e and En v ir on mental Rel ease Summary:

#S ites Workers Exposure
. (days / year) Inhalation Exposure (mg/day) Process 

# I 

# I I L_ Use 

# I 

# I I

Ri sk to Work ers: Co ncern for lun g toxici ty if inh aled based on lun g overload for poorly so lu b le p arti c ul ates ( 40% < l 0 um).

V. EPA'S CONCLUS I ONS OF LAW The following findin gs constitute the b as is of th e Consen t Ord e r : (a) E P A is unab le to de termine the potential for h uman health e f fects f rom exposure of human s to th e PMN s ubstan ce . EPA the ref o re concludes, pur s uant to 

### § S(e) (J )(A)(i) ofTSCA, that the inf o rm at io n avai lable to the Agency is insuffic i ent to pe rmit a r easo ned eva lu at io n of th e human 

### h

eal th effec ts of the 

### PMN substance.VI
(b) In li ght of the potential risk ofhuman he a lth po se d by the uncontrolled manufacture (which includes impo11), processing, distribution in com mer ce . u se. and disposal of the PMN s ub stance . EPA ha s concluded, pursuant to 

### § 5(e)( I )(A)(i i )( l) ofTSCJ\, th at**ur~comrolled** mnnufactur ?, · processing. distribution in commerce, use, and disposal ofthc PMN subs tanc e may present an unreasonable r isk of i nju ry to hum a n health.



# . Y l. INFO RVIATJON REQUIRED TO EVALlJ ATE H UMAN H RALT H AN D**ENVIRONM ~N** **L** EFFEC T S Pend ed Testing. The following additional inf ormation would be required to evaluate th e following effec t s which may he caused by the P:vrN s ub stance: I nformation Effect s Guidelines · A 90-day inhalation toxicity tes t Fibrogenicity OCSPP 870.3465

The Order docs n ot require subm iss ion of the above pended te s ting at any spec ified time or production volume
. However. the Order's res tri ct io ns on**m~nufacture ,**  processing, a nd u sc of the P:vr.\ s ubstance will remain in effect until the Ord er is modified or re voked 

### by E PA ba sed on
s ubmi ss ion of that or other re levant information
.UNIT ED STATES ENV IRONMENTAL PROTECTI O N AGENCY WASH NGTON, D.C. 20460



## C O NSENT ORD E R

I. SC OPb: OF APPL I CABILITY AN D**EX ONS**  (a) Scope. The req uirements of thi s Orde r apply to a ll com mercial m an ufacturin g, proce ss in g, distr ibut i on in commerce, use and disp osa l of the chem ical subs tance

- ( P-1 5-328)("thc PMN substance'') in the United States by (''the

Co mpany "), except to the ex tent that tho se activi t ies are exempted by paragraph (b).
(b) Exempt ions. Manufacturing, proce ss ing, di s trib uti on in commerce, usc and d i sposal o f the PMN subs tance i s exe mpt from the re q uirement s of Lhis Order (except th e requirements in the Rccordkc ep ing and Successor Liab ili ty U pon T r ansfe r Of Consen t Orde r sections) on l y to the
ex tent that ( 1) these activit ies are conducted in full compliance with all applicable requirements of th e following exemptions, and (2) such comp l iance is docume n ted by app r opriate r ecordkeeping as required in the Rc co rd.keepin g sec ti on of thi s Order. Internet Addross (U HL) • http //www ep a .gov RecyclodiRoc:yc;lable •**Prf~lttd** with V<>;etabl& Od Bosoo**l~k'** on 100 %**Pcstcons~ornor, Proco~s**  Ch!oru1o Foou Rocycto:l PJPUr- 1 - ( 1) Exp o rt. Until the Company begins commercial manufacture of the P M)-1 substance for
u sc in t h e Un i ted S tatt!S, the requi rements of thi s Order do not app l y to manufacture , proc ess ing or distribution in commerce of the PMN subs tance so lely for expor t in accordance with TSCA §§ 12(a) and 12(b) , 40 CFR 720.3(s) and 40 CFR Part 707. How ever, once the Company h egins to
man u fac tur e th e PtvrN subs t a n ce f or usc in the Un it e d S t ates . no ftwthcr ac ti v it y by th e Com p any involving the PMN substance is exemp t as "so lely l or export'" eve n if some a m ount o f t he PMN substance is later exported. At that poin t , the requirements of this Order apply to all activities
assoc iated with the P MN s ub sta n ce w hil e in th e te rrit ory of t h e Uni te d S tates . Prior t o leaving

. .. . . U.S. territory , even**tho~e** quantities or batches o f th e PMN subs tan ce that are d est ined for export
are subject t o terms of the Order, and cou nt towards any pro duction volume test triggers in th e Testing sec tio n of th i s Order. (2) & _s ea rch & D evelopment (" R&D"). The requ ir emen t s o f this Order do not apply to manufacturing, process in g . d i stributi on in commerce. use and disposal of the P\tfN substa nce in
sma ll qu an titie s so l ely for re sea rch and develo p me nt in**accord~u1ce-wi th**  TSCA §5(h)(3), 40 CfR 720.J(cc), and 40 CFR 720
. 36. The requirements of thi s Order a l so do not apply to m a nu fac turin g, processing, distribution in commerce, usc and d i s posal of the Pt-.1N s ubstance when manufactured solely for non-commercia l research and developme n t per TSCA §5( i) and 40 CFR 7 20 .30 (i)
. . (3) Byproducts. The r eq uire m ents of th is Orde r do not apply to th e P MN s u bs t a n ce "Yhen it is produced, without se parate co mm e rcial in t em, only a s a '·byproduct" a s defined at 40 CfR 720.3(d) a nd in compl iance with 40 CFR 720.30(g). (4) No Separa te Comme r cia l**Puro.os~ .**  T he requiremen t s of thi s Orde r do n ot apply to the PMN substance when it is manufactured. pursuant to a ny of the exemp ti ons in 40 CFR 720.30(11), with no commercial purpose separate from th e substance, mixture, or article of which it i s a part.- 2- (5) Imp o r ted Art icl es. The require men t s of this Order d o not app ly to th e PMN s u bs t ance when it i s imported as part of an "article" as defined at 40 CFR 720.3(c) and in compl i ance wilh 40 CF R 720.22(b)( 1 ). 

### (6) Complete l y Reacted (Cured)
. The requ ir emen t s of th is Order do not app l y to quanti**tic ~**  of the 

### PMN substance after they h ave been completely react ed (cured)
. (c) Automatic Sunset. If the Company has obtained for the PMN substance a Test Market Exemption ( " T M E") under TSCA §S(h)( l ) and 40 C FR 720
. 38 or a Low Volume Exemption

0 0 0 (''LYE") or Low Release and Exposure Exemption (''LoREX") under TSCA §5(h)(4) and 40 CFR 723
. 50(c)( I ) and (2) respectively, any such exe m pt ion is au to ma ti ca ll y rendered null and vo id as of the effective date of this Consent Order.

II. TERMS OF MANUFACTURE, PRO CESS I NG, Dl S TRIRUTJO N I N COMME R CE, USE, AND DISPO SA L PENDI NG SUB MIS S IO N AN D EVA L UA TION OF I NFORMAT IO N
PROHI B ITION The Company is prohibited from manufacturing (wh ich under TSCA i ncludes importing ), processi n g, d istribut i ng in commerce, using, o r disposing of the PMN substance in the United S t

ates, for any nonexempt commercia l purpose, pending t he develo p ment o f information necessary for a reasoned evaluation of the human he al th effects of the su bstru1cc , and the comp letion of EPA's review of, and regu latory act i on based on, that information, except in accordance with the 

### condition s described in this Order.- 3

- 

### T ESTING (a) Sect ion 8(e) Re porting. Reports ofinfonnation on the 

### PM N s u l;>stance which reasonab ly · s upports th e conclu s ion tha t th e PMN s ub s tance p resen ts a s u bs tantial ri sk o f injury to health o r th e envi ronment and wh ich is required to be re po rted under TSCI\ section 8(e) shall**efe enc~** **th~** approp ri ate PMN identification numb er for this su b stan ce and co ntain n sta tem en t that th e substa nce is s ubject t o this Co n sent Order. Addi t iona l inform a tion reg ard in g sec tion 8(e) r c por1in g requirements can be f o und at www.epa.gov/opptltsca8e
. (b) Not ice of Stu dy Sc h edul in g. The Co mpan y shall notify , in wri ting, the E P A Monitoring Ass i stance and Media Progra m s Divi sio n , Offic e of Enforc eme nt a nd C omplian ce Assurance, U .S. Envi r onmental Protec ti o n Agency, of th e f o ll owi ng inform atio n wil)1in I 0 day s of schedulin g·an y
s tudy required to be p e rf o rm ed pursuant to th is Order. o r w ith in 15 day s a ft er the effective date o f this Order. whichever is l ater: ( I ) The date whe n the study is sc hed uled to commence; (2) The nam e a nd address of lhe laboratory which w il l co nduct the s tudy; (3) The name a nd te lep h one numb er of a person at th e Co mpany o r the la bor atory w hom EP 1\ m ay co nt act regarding the s tud y; a nd , (4) T he appropr ia te P1vfN identi fi cation number for eac h substance and a s tatem ent that the
s ubstance is s ubject to th is Co n se nt Order. The wr in c n notice shoul d be submitted to E PA as f o ll ows : Po s t al Mail Address U.S. Env ir o nm e nt a l Pro tec ti on Agency G LP Sec tion C hi ef- Pts t icides, Water and Toxics Branc h- 4- Monitor ing Assis tance and Media Prog rams D iv i sion (2227 A) Office of Enforcement and Compliance Assurance 1200 P ennsylvania Avenue, N.W. Washingto n, DC 20460

Courier De livery Add r ess U.S. Environme ntal Protection Agency G LP Section C hief

- P · cs t ic ides, Wate r and T ox ics Bran ch Monito r ing Assistance and Media Programs Division (2227 A) Office of Enforcement and Compliance Assura nce Room 7117 8 I 200 Pennsy lvania A venue, N. W. Wash ingto n . DC 20004
(c) Good Labora t ory Prac tice Standa rd s and**T~st** Protocols. Each s tudy pe r formed to address the risks identified in this Order must be conducted acco rd i ng to TSCA Good Laboratory Practice Standards at 40 CF R Part 792 and using methodologies gene rally accepted in the relevant
sc ient ific community at th e t i me the study i s ini ti ated. Before starting to conduc t any s tu dy that v.rill u sc a modified version of a pub l ished t es t gu ideline, the Company m u st subm i t \Witten test protoco l s to EPA for review (s ubmission of written test protocols is optional for tests that arl! to be conducted us i ng unmodified published tes t guidelines)
. Protocols must be submitted as a support document for the PMN, u s i ng the procedures set o ut in 40 CFR 720.40. EP A w i ll r espond to the

### - 5

- Com pany within 4 weeks of receiving the written protocols. EPA rev iew of a test protocol does not mean pre-acceptance of test re s ults.
(d) Unreasonab le Risk. EPA may notify the Compa ny in writing that EPA find s tha t t h e data generated by a study
a r e scie n t ifical ly valid and un equivoca l and indicat e that, de s pite the tcnns of th i s Order, the PMN substance will or may present an unreasonable ri sk of injury to human health or the environment. E PA 's notice may s pecify that the Company undertake certain actions co n cerning further te st ing ,
. . . manufacture, processing, distribution, u sc and/or disposal of the PMN substance to mitigate exposures to or to better characterize the ri s ks pre se nted by the PMN s ub sta nce. Withi n 2 weeks from receipt of such a noti ce, th e Company mu st cease all manufacture, proces sing, distr ibution,
u se and d isposal of the PMN s ub stance, unless eit h e r : ( 1) within 2 weeks from receipt of the EPA no tice, t:he Company complies with such requirements as the notice s p ec ifi cs; o r (2) w i thin 4 weeks from receipt of the E PA notice, the Company s ubmits to EPA a written report refuti n g EPA's linding and/or the appropria ten ess of any additional re qu ire m ents imposed hy F.PA. The Compa ny may cont i nue to manufacture , proce ss, distribute, use and di s pose 

# . of the**PM~** s ub stance in accordance with the tem1 s o f thi s Order pcndi ng EPA· s response to the Company's written report. EPA will res p ond to the Company, i n writing, within 4 weeks o f receiving the Company's report. Wit h in 2 weeks of receip t of E PA' s written resp onse . the Company s hall comply with any requirements imposed by EPA's response or cease all manufacture, pro cess ing, di stribution , u sc and dispo sal of the PMN
. subs tance.- 6

- PROT EC TIO N I N T H E \ VO RKPL ACE (a) hS t ablis h men t of Program. Durin g man ufa c turin g . processi ng, a nd u sc of th e PMN substance
a t any s i te cont rolled by the Co mpany ( in c l uding any associa t ed packag in g and s torage and during
a ny cl ea nin g or maintenan ce of e quipm ent assoc iated wi th th e PMN s ubstanc e), the Company must estab li s h a progra m whereby: ( I) Respi rat ory Protec ti o n. Each pe r so n who is reaso n ab ly like ly to be exposed by inha l at io n in the wo rk area to th e PYJN substance in the form listed in subparagraph (a)(2) of this sect i on i s pro v id e d with and is requir e d t o wea r, at a minimu m , a N a t ionalln st itut e for

. . 

### . Occ up a tional Safety a nd H enlU 1 ("N IOS H" )

- ccrtiiied respi ra to r w ith a n App li e d Pr otection Factor (''A Pfo'' ') of I 0, from the re spira t o rs li sted in s ubpara g raph (a)(3) of this section , a nd the resp ir ator is used i n accordance wi t h OS llA and N IO S H resp iratory pro tectio n req uirement s at 29 CFR 1 9 1 0.134 and 42 CFR P a tt 84. All respirators must be issued
. ust:d. a nd mainta ined acco rdi n g to
nn app ro priat e r es piratory prot ' eetion p rog r a

m unde r th e OSHA requ ireme nt s in 29 Cfo' R 1910.13 4. (2) Physical States. The follow in g ph ysical s t a t

es of airborne chemical subs tances are listed for s ub pa r agr aph (a)(l) of thi s sect io n: (i) P arti culate (including sol ids or liquid drop lets), ( ii ) Ga s/vapo r (all subs tances in th e gas fonn), or (iii) Co mbinati on Ga sNapor a nd P art iculate (gas and l iq uid/so l id physical s t a les arc present; a goo d example i s p ai nt sp ray mist, whi c h co nt a in s bo th liq uid dro pl ets and va p or)
. (3) Aulhorizt:d R espirators
. The fo llo w ing N J OSH-certiftcd respirators meet the minimum requ ire ment s for s ub pa ragra ph (a)( I ) of thi s se ction:A ss igned Pt'otcction - 7-

T y pe 

### of Respirator ( I) Any NIOSH-cer1i fied air-purif y ing clas tom eric half-ma sk respirator equ ipped w it h NlOO (if oi l ae roso l s absen t) , R lOO, o r Pl OO filter s . ( II ) Any appropr iat e 1 IOS H-cc rtified N I 00 (if o il aer oso l s absen t), R 1 00, or P 1 00 filt ering facepiecc r espirat o r. [Note: for filtc1ing facep ie ccs, an APf' o f I 0 can o nly be <tch ie vcd if the r esp irator is qu a l itative ly o r quantitatively fit t ested o n indi v idua l wo r ke rs. ( Ill ) Any N IOSH-cert ifi ed air-purif y in g f ull facep i ecc resp irator eq uipp ed with N I 00 (if oil aeroso l s abse nt). Rl 00 , or PI 00 filt er s . ( I V) Any N I OS H -certi i ied nega ti ve pn;ssure (demand) s upplied

- air resp ir ator equipped with a hal f-mask
.. (V) Any N IOSH-certified negative pres s ure (demand) s elf-contained

.__ ____ _,_ b

_

r

_ e

_ a

_

th

_

i

_ n-">---'- aeparat u s ( SCBA) equipped with a ha .c.: l f

'--' ·**;..__:_: _;** **··**___ ____**___~** (b) De Minimi s Concen trati o ns . The requirement s of thi s sec ti o n d o not apply to quan tit ie s of th e PMN sub sta nce that arc (1) pre se nt in th e work a r ea on ly as a mixtur e and (2) a t a co ncentrat ion not to exceed 1.0 percen t by we ig ht o r volume (0 .1 perce nt by weight or vol ume if the PMN substa n ce i s ide n tified as a potential carc in oge n in para g raph (f) o f the H aza rd Co mmunic ation Program secti o n of thi s Ord e r). Thi s exemption i s not ava il ahle 

### if the Comp a n y ha s reaso n t o believe th at , during int e nded activ i ties, th e Ptvf N s ub s ta nce in the mixtur e m ay be r eco ncentrated above t he 

### l.O o r 0 .1 percent leve l. whi cheve r applies. I f th i s Order co ntai ns )Jew Ch emi cal Expos ur e Limit s provisions or R elease to Water prov i s io n s th a t , r espec tive l y, speci f y a NCEL
conce ntration ("TWA'') o r in

- s tream concent rat ion ("N") less than th e de minim is concentration specifie d here, th en thi s de minimi s ex e mption does not a ppl y t o those provi s ion s .

### - 8

- NEW CHEM J CAL EX POS U Rll :: LTMTT (a) Alternative to Requirements of Respirato r Section. ( I ) EPA recommends and encourages th e u se of pollution prevention, so urce reduction, enginee ring contro l s and work practices, rather than respirators, as a means of con troll ing inhalation exposures whenever practicable. (2) Whenever a person is reasonably li ke ly to be exposed to th e Pl\1N substance by inhalation, as an alterna t ive to compliance \ Vi th th e r espirator requirements in the Protection in the Workp lace sect io n of thi s Ord er, th e Compa ny m ay comp ly**wi ~**  the requirements of this New



### . . ... ... Chemical Exposure Lim it section. Hmvever , before th e Company may deviate from the respirator requi r emen t s in the Protection in the Workplace sect ion of this Order, the Company mu st: (i) submit to EPA a copy of the Company's sampling and analytical method for the Ptv1N substance, ve rifi ed in accordance with subsec ti on (c)(3) of this New Chem ica l Exposure Limit sect ion; (ii) obtain exposure monitoring r esu lts in accordance with this )Jew Chemical Exposure Limit sect ion; and. (iii) based on those expos ur e monitoring resu lt s, selec t , provide. and ensure usc if necessary of th e appropria te respi r atory protection spec ifi ed in para&.rraph (e)(2) of this New Chemica] Expos ure Limi t section by persons who arc r easonably likely to be exposed to the PM)J substance by inhalation. (3) After appropr i ate respiratory protection has been se le cted at a workplace based on the results of actual exposure monitoring conducted in accordance v.rith this Ne\v Chemical Expo s ure Limit sect ion , the Company shall not, a t that workplace, u sc th e r espirato ry protection required in- 9- the Protection in the Workplace section of this Order unless it is the same as required by this New Chemical Exposure Limit section.
(h) Exposure Limil. (I) General. The following new chemical exposure lim it ("1\CEL") for the**P~11\** substance is an interim level determ in ed by EPA based on the limit ed information avai l able 10 the Agency at the time of deve lo pment of this Order. The NCEL for the PMN substance is as follows: (i) Time-Weigh ted Average ("TWA
.. ) Limit. ' I he Company shall ensure that no person is exposed to an airborne concentration of the PMN substance in excess of 5 mg/ m 3 ( the NCEL) as an 8-hour time-weighted average, without using a respirator in accordance with subs ection (e) of this New Chem ical Exposure Limit section. (ii) Non-8-Hour Work- s h i fts. For n on -8-h our wor k -shifts, the N.CEL for that work-shift**~CELn)** shal l be determined by the following equation : NCELn 

## =NCEL x (8/n) x l(24- n)IJ 6J, where n '" the numb er of hours i n the actual work-shift. (2) Automatic Sunset. If, subseque nt t o the effective da te of this Order, OS! I A promu l gates, purs u an t to §6 of the Occ u pational Safety and Health Act, 29 C.S.C. 655, a fina · l che mical- spec ific pe rmi ss ibl e exposure limit ("PEL") spec ifi cally app li cab le to this PMN substa nce and the OS I JA PEL is not challenged in court w i thin 60 days of its promulgation, then any respirator requirements in the Protection in the Workp l ace section of this Order and any requirements of th is New Chemical Exposure Limit section applicable to wor kers and situations subjec t t o the OSHA PEL s ha l l a ut omatica ll y become null and void. However , the requirements o f this Consent Order ar e not negated by a ny pre-exi st ing OSHA PEL applicable to the PMN subs tanc e .- 10- (c) Performan ce - Cri ter i a f or. amp l ing and Analyt ical Method. (I) App lic abil it y. For initi a l development and val id ati o n o f the sa mplin g and a na l yt i cal meth od for th e PM N s u bs ta nce, a ll the requ iremen ts of thi s sub sec tion (c) a pply. Fo r su bsequen t exposure monitoring conduc ted pursuant to subsect ion (d) of this New Chem ica l Expos ure Limit
sec ti o n, only the following requirements apply: (c)(4)( i), (4)( ii ), (4)(iv)( H), ( 4)(v)( Il ), (8), and (9). Any dev i ation fr o m thl! requireme nt s ofthis subse ction (c) mu s t be a ppr oved in writing by EPA. (2) Subm iss ion of Verified Method and Cert ifi cati o n Stateme nt. The Company s hal l submit to EPA a copy of a ·va lid uted sa mplin g and analyt ical method for the PMN substance which

.. 

### . . . satisJies the cri teri a s pec ified in this subsect i o n (c). The met ho d description s h all express l y stat e how t he method compares 'vY i th each quantitative requirement spec ifi ed in this s u bsect io n (c). T he subm i ssion mus t in clude a wr ill e n s t atemen t , signe d by a uth o ri ze d officials of both the Company and the Labo ratory , ce rtif ying the tru th a nd accuracy of the ind epe nd e nt l abo ratory verilication cond ucted pursuant to subsect ion (c)(3). To assis t EP A in iden t ifyi n g t h e document, it sha ll state in a conspicuous, underlined subject -lin e at th e top of the first page: " NCEL Samp lin g and A na ly ti cal Method fo r Piv f N # J >- 1 5-328 " . (3) Verificat ion of Anal) tical Mcthud by ln dcpc 11dt:llt ThinJ-Ptuty Laboratory
. (i) Verification. The Company s h all have an ind ependent refe re nce laboratory ("Laboratory") ve ri fy the va lidity of t he a na lyti ca l method for th e PMN s ub s ta nce, in accordance
w ith the othe r requ ire ment s in thi s subsection (e)(3)
. It i s the Company's respon s ib i lity to ensure that the Laboratory comp l ies w ith al l the r equirements spec ifi ed in thi s subsec ti on (c)(3)
. ( ii ) I ndepe nd en t Reference Laboratory. The independent refe rence labora tory must be a separate and di st in ct per so n (as defined at 40 CFR 720.3(x)) from th e Company and from any
o th er person who may have dtveloped the mtthod for the Company
.- 1 1

- (iii) Accreditation. The Labo r atory must be accredited hy a formal l y recognized govern ment o r pri va t e laborato ry accredi tati on pr ogra m f or chemica l test i ng and/or a nal ysis. (iv) Good Lab o r atory Pr ac ti ce Sta nda rds. The Labora tory ve rifi catio n of th e
ana lytical method for the PMN s ub s tan ce must comp l y w i th T SCA
.Good Laboratory Pr act ice Standards ("GL P S") at40 CFR P a rt 792. (Certain provi s ions of th e T SCA GLPS app lic ab le to t oxic it y testing in laboratory a nimals, s uch as 40 CfR 792.43 ("Tes t system ca re fa c i lities''), 792.45 ("Tc · t system suppl y fac ili tie s ' ') and 792.90 ("A nim a l and other t es t system care>'). are
c learl y inappli cab le to th e NCE L requirements.) However, comp liance w it h TSCI\ GL P S is n ot

. . . . required under thi s New Chemical Exposure Limi t section w he re tlie analyt ica l me th od i s ver ifi ed by a laboratory acc redi ted by e ither: (A) the Ame ri can Ind ustria l ll ygic nc Associa ti o n ("A ll lA ") Industria l Hygie ne Laborato r y Accredita tion P rog ram (" IH LA P "); o r (I3) a nother com parabl e program a pproved in advance in writin g by EPA. (v) Analysis of Duplicate Samp les. The Company**~ha ll**  co ll ec t s ix duplicat e · samp l es (a total of 12) at t he TWA concentration. Th e sa mp les s h a ll be take n e i the r f rom a control led environment (e
. g., a sc aled c h a mb er or "g lov e box") w hi c h closely resem bl es the ac tu al workp l ace conditio n s or, f o r solids and liqu ids wi th very low vapor pressure, by in ject i ng th e PtvfN subs tan ce onto a samp le co ll ec ti o n device. T he duplicate sa mpl es shal l he co ll ected on i dent ical
co ll ec ti o n med ia , at the sa me t im e, and und er th e sa me conditio ns. ' o ne set of s ix sa mp les s hall immediately be an alyzed by th e Company, U1e othe r set o f six samples s h a ll be ana l yzed by the I , abo r ato r y using the met hod developed by o r fo r the Company. (vi) Sample Sto@gc S tu dy. lf th e re sults of th e a naly s is of d upli cate sa m ples pursuant to paragraph (c)(J)(v) do not satisfy th e requ i reme n ts in**p~ agrap** **h** (c)(3)(v ii ), the Company must pe rf orm a sample s torage s t udy as follows:- 12- ( 1

) Trigli cate Samples. Th e Company s ha ll collect six triplicate samples (a to t a l of 18 ) at the TWA concen t ration. The sa mple s sha ll be taken ei th er from a contro ll ed environm ent (e
. g., a sea led c h amber o r "glove box") whi ch cl ose ly re se mbles the actual workplace conditions or, for so l ids and li qu id s w ith very lov: vapor pressure, by injecting th e**~** substa nc(!
o nt o a sample co ll ection device. The tripli cat e sa mp les s h a ll be co ll ected on id e nt ica l co ll ec ti o n



# . medi a, a t the sa m e tim e, and under th e same co n d i tions. One se t of six sa mpl es s hall imm ediately be analyzed by the Co mpan y. ( ll ) Analys i s Afte r Sample Storage. A sam ple storage eva lu ati o n s h a ll be



### . . perf ormed wit h tl1c two rem a inin g se ts of s ix sa mpl es . One set o f s ix sa mples sha ll be a nal yzed by the Labo ratory usin g th e meth od developed by or f or th e Company, and th e other shall be ana lyzed by th e Co mp any on th e same day as th e Laboratory ana lyzes it s s ix sa m p les . Specia lized sto ra ge cond iti o ns for the sa mpl es including ext ra c ti o n c o nditi ons, time f ro m sa m p lin g t o ex trac ti on, tim e from co lle c ti o n or ex tr ac ti on (if app li cab le) to ana lysis and s torage condit ions mu st be speci fi ed in the me th o d de sc r iption. (v ii) Comparison ofResu lts. T he diff er

ence be tween the re s ults ofthe t wo se ts of six sa mp l es analyze d by the Labo ra tory and th e Co mp any as r equired in e i ther paragraph (c)(J)(v)
o r (c)(J)(v i )(J l ) sha ll he eva lu ated us ing a tw o - s ample t- tes t with unequal vari ances, and the two
s ides o f the cri ti cal reg ions sh a ll not exceed a 5% s ig nificanc e lev e l. (Sec Attac hm e nt C

- Statistical Analys i s of C EL s Analytical M e th od Ve rifica tion Results.) 

### TI1e ave ra ge of each set o f six sa mp les mu s £be wi thin I 0% of the tru e va lut:. If the ave ragt: of each se t of s i x samp l es is not within l 0% o f the true va lu e, th en th e sa mp l e st o ra ge tim e between co lle ct i on and analys i s mu s t be redu ced until th e average of each se t of s ix samp les is with in I 0% o f the tn1e va lu e .- 13 - (4) Ac c uracy. The sampling and analytical method must clearly
. demonstrate the following: (i) Genera l. The sampling and analytical method , and a11 exposure monitoring data relied on by the Company , shall be accurate to within ±2 5% at a 95% confidence level for concentrations of the PMN substance ranging fr om one half the**~CEL** to twice th e NCEL. (ii) NCEL Quantitation Limits. The analyti ca l method shou ld be capab l e of reliably quantifying the PMN substance across the full range of reasonably likely exposures . At a minimum, the analytica l method must be capab le of r eliably quanti fying from a lower quantitation

. . . 

### - limit ("LQL ") of one ha lf the NCEL to an uppe r quantitation limit ("UQL") of a t least twi ce the NCEL. I f the Company obtains an exposure monitoring sample that is mo r e than 10% above
. thc nctun l 

### UQL of the analytical method , th e Company must comply with paragraph (c)(4)(i)
. ( iii ) Lower Quantitation Limit Signal-To

-Noise Ra tio. T he analytica l method shal l be capable of quantify in g the PMN t o a concentratio n o f one h a l f t he NCEL with a sig nal that is at lea s t five time s the baseline noise le ve l. Baseline noi se must be amp lifi ed to a measurable level when possible, even if th e required amplification is beyond th at usc'd in rout ine a nal ys is of samples. (If baseline noise cann ot be obtaine d , another reference must be selected
. Thi s mny be a peak considered to be no ise caused by the reagent matrix .) The sampling preparation method must be speciliecl ru1d the detl.!ction limit for the analy t ical proce dure must be r eported as mass per inject ion for chromatographic techniques. (iv) Instrument Calibration. (I) Ini tia l Cal ibra J.io n. for method development and validation (but not subseq uent exposure monitoring), the initial ca li brati on shall at a minimum consist o f five (5) calibration standards with a linear correlation of0.95 --the se five (5) calibration sta ndards must- 14 - consist of one s tandard at each of th e fo ll owi ng concentrations: one ha lf 1h e NCEL (0.5 x NCEL); between o ne half and one tim es the NCEL (>0 .5 x NCCL ,< I x NCEL); one tim es the NCEL ( I x NCEL); between one and two ti mes th e NCE L 

### (> I x NCEL, < 

### 2 

### x NCEL), and tw i ce the 

### NCEL (2
X NCEL). (II) Continuing Calibra t ion
. During eac h week o f both method devclopmenUvalid at io n and subseq uent ex posure m on it or in g, th e Co mpan y shall conduct both an initi a l instrumen t calibration and a continuing calibration
. The Company shall perform at least one cont inu in g ca li brat ion sn mple a t th e NCEL concentration, and at least one add i ti onal ca li bration



### . . 

### . samp le per eve ry I 0 sa mpl es an alyzed. The con tinuin g ca libr ati on sample shall fall w ith in± 25% of th e initial cali bra ti on va lu e. I f not, then the initial calibration must be r epeated, and any sample s associated with that outlying calibration check must be re-a nalyzed. (v) Calcu lated P e r

cen t Recovery. ( I) Initi a l Calculation. For method develop m ent and validntion, th e Company mu s t calcu l ate the pe r cent of the**PM~** substance re cove red by the analyt ica l me t hod from a sampk co ntainin g a kn ow n q uan tity of tht! PMN s ubstance. The sa mpl e sha ll be take n either fro m a contro ll ed env ir onmen t (e.g
. , a scaled chamber' o r ' · glove box") which c l osely
re sembles th e act ual workplace conditions or, fo r solids and li quids w i th ve r y low vapo r press ure , by inj ec tin g the PMN subs t ance onto a sa mpl e co ll ect ion de vice. (S uc h a s amp le is referred to as n "mat ri x spike"). The calcu l ated percent recovery for each matrix sp ike s hall be greater than or equal to 75% and Je ss than o r equa l to 1 25%
. Sp ike concentrat i ons f or the PMN s ub stance mu st be included in th e sam pling and unalytical method s ubmitted to EPA. ( ll ) Subsequen t Calc ul at ion. During eac h subsequent exposure mon itoring ep isode or campaign, at least l matrix spike. prepared by injectin g the 

### PMN substance onto a- 15

- sample collection device, sha ll be analyzed. (This matrix spike mu st be prepa red at U 1 e NCEL concentration.)(vi) Sampling D evice Capac itv. The capacity of th e. sampling device must be tested and resu lt s reported t o s h ow u n der a known and we ll -defined se t of conditions that th e device is capable of collecting t h e new che m ica l in sol id, l iq u id o r vapo r ph ase with m in im a l loss. The sampling dev ice's capacity (air vo lume and collec t ed analy te mass) must be specified. for methods that use adsorbent tubes as the collection medium, evidence of the capacity must be provided in the form of breaktlu·o u gh testing. Th i s testing mu st be done at a co n centration twice



### . . 

### . the NCEL a n d u n de r conditions s i mi lar to those expected in the wo rkp lace. B reakt hrough i s defined to have occurred when t he conce n trat ion of lh c:: 

### P
. MN subs tance i n the effl u en t st r ea m is cqunlto 5 % of the concentrat ion of the influent stream, or whe n 20% of the PMN substa n ce is detected in the backup section of th e samp l er. (vi i) Sa m p l ing Device Desorption Effic iency . Where app l icab l e, t h e desorption e11ic iency m u st be eva luated fo r the a ir sampling device. A m i nimu m of six air samples sp ik ed with the PMN suhstance at l eas t the NCEL concen tra ti o n m u s t be pre p are d
. A**r~cove y**  of a t [ e(lsl 75 % must be obtained for each of the six samples
. (5) ]>recision. The estimate of the coefficient of variation of each se t of six samples from the controlkd atmosphere test (spiked at I .0 NCEL, per paragraphs (c)(3)(v) or (vi)) must be le ss than 0. 1 05, incl u ding a ll owance of 0.05 for erro r due to samp li n g. (6) Interpretat io n of Accuracy an d Precision Data. (i) lf a sing le matrix spike recovery is Jess th a n 75% r ecove ry or g reater than I 25%
or the estimated precision is grea t e r than 0.1 05, then t he Company must rc-prepare t he matrix- I 6- spike, re-sample, and re-analyze all samples associated with such matrix spike or triplicate 

### samples. ( ii) For percent recoveries less than 90% bu t g reater th an 75%, co rre ct ion for low recovery is required. Correct for recovery first by dividing the observed amount by the proportion recovered bdore determining if measurements fall below the NCEL. For examp l e, ifthc observed leve l is 30 mg/m 3 and the percent recovery is 75%, usc the value 30 mg/m 3 /(0.75) = 40 mg/m 3 when determining whe ther tht! levels are below the exposure limit. (7) Representativeness. All sample conditions used to develop the methodology sha ll



## . . mimic the. actual wo r kplace environmen t expected to be moni tored. Conditions such a<; the**temp~raturc,** hum idity, lighting. and presence of other chemica ls, etc . must mimic t he conditions in the workplace to be monitored. (8) Changes Affec tin g Validity. lith e wo rkpl ace environment changes from th e initi al cond i tions described in the verified sampling and ana l ytical method in a way reasonably likely to invalidate the accuracy of the method, then the Company must comply with the respirator requirement s i n the Protection in th e Workp l ace sect ion of this Order, un less t h e Company reva lidates the method to confirm tha t the requirements for accuracy and precis ion in paragraphs (c ) (4) and (5) are met. Exan1ples of possible changes include but a re not limited to: introduction 

### of a new chemica l substa nce to the workplace which may in t erfe r e wi th the a naly s i s of th e new chemical; introduction of light to the workplace which may**intcrf~re** with 

### a light-sensitive PMN substance; or int roduction of water/increased hum idit y to the workplace which cou ld react w it h the 

### Plvtl'\ subs t ance and cause difficu lt ies in collection and analysis. (9) Comparability. Al l data and results shall be reported in the same units of measurement


### as the NCEL.- 17 - (I 0) ResponsibilitY. for Method Validity. The**indep~ndent** labo r atory verificat ion and EPA receipt of the samp lin g and analytica l method pursuant to this s ub sec ti on (c) do no t e n sure that th e method w ill p rod u ce va li d exposure mo nit o rin g data. The Com pany is ult imately r esponsible for
e n suring the va lidity of i ts expos ure mo nitoring data.
(d )**Monitorin~** Pote nt ial Exposure
. (I) General. (i) ;\c ti on Level. The "act ion leve l " i s defined as an airborne concentrati o n of the PMN s ub s tance , ca lc u lated as a n 8-hour t im e-weig ht ed average,**eq~ta l**  to one ha lf th e NCEL TW A specified in s ubp aragr a ph (b)(l ). For non -8- hour work shifts, th e actio n leve l is eq ual to o n e h a l f the**~CELn.** (T h e NCELn i s described in subparagraph ( b )( I )(ii).) The Co mp any may exceed the action level w i thout pena lly. Tbc purpose of th e act ion lev d is solely t o determine th e requis i te monitoring fi"equcncy
. (ii) Represen tative Exposu r e Groups. Wheneve r exposu re monitoring is requ ired by thi s New C hemi cal Ex po s ure Lim it sec t ion, the Company s h a ll take represe nt a ti ve sam p les of what the po tential exposu r e of each person who is reasonably likely to be ex posed to a ir borne
concen tr ations of the PMN suhstance would be if respirators were nol worn. The Co mpan y shall do so by sampling th e breathing zone ai r of at l east one per son that rep r esen ts, and docs not underestimate, the pote nti al expos ure of eve r y pe rson pe rform i ng t he same o r substa n tially s imil ar operations in eac h work sh ift, in eac h job classification, in eac h wo rk are a (hcre in aftt.:: r idcn tificd as an "exposure group"') whe re in halation expos ure to the**P~1N** substa n ce is reasonab ly likely to
occur. The exposure of each person n eed not be itself di r ect ly sampled if that ex p osu r e is represented by sampling th e exposure of anot h er pe rson in the same exposu r e group.- 1 8 - (i i i) Goo d L a borato r y Pr ac ti ce S tandards
. De t e rmin ati o ns o f po te nti a l in h al a1ion expos ure s hall be mad e according to TSCA Goo d L aboratory P ractice S tandards at 40 CFR Part 792 a nd th e sampling a nd a na lytica l method developed pursua nt to s ubsect i on (c) of this New Chemical Ex p osu r e Lim i t sect ion . 

### (Certa in p rov isio ns of the TSCA GLP S ap p licab le t o t ox ic i ty tes ti ng in lab ora tory a nim a ls,**ch** as 40 CF R 792.43 (" Tes t sys te m ca r e fac i liti es"), 792
. 45 ("Test sys t e m s uppl y faci l ities" ) a nd 792
. 90 ("A nim a l and othe r tes t sys te m care"), are c l earl y in ap p licab le to Lhe NCEL requi r ements.) H owever, compl i ance wit h TSCA GL P S i s no t re q uirl!d where exposu r e moni to rin g samp les nre an alyzed by a laborato ry accred i ted by either: (A) the



### . . . .. A IHA JJ I L/\P; or ( B ) anot h er comparab le p r ogram app roved in adva nce i n v vr i ti ng by EPA. ( iY ) Full S hift**E~QQ_surc** Samp les . R e prese n tCl ti vc 8- h o ur TW A airborne
co nce n tra t ions sha ll be d ete rm ined on th e basis o f sa mp les r e pr esen ti ng t he full sh ift exposu r e for
eac h ex posure grou p . (2) In i tial Mon it or i ng. I3efo r c th e Company may dev ia t e f rom the respirator requirements of the P ro tectio n in th e Wo r kp lace sectio n , the Co mp any s h a ll cond uct init ial exposu r e mon i tor in g t o acc ura t ely dete rmin e th e a irbo rn e con cen trat io n of th e PMN s ub sta nc e f o r eac h ex p osure gro u p in whi c h p e r so n s are reaso nably like ly to be ex p ose d to the PMN substa n ce. (3) P eri odic \!Jon it oring. (i) I f any represen ta ti ve samp les take n d ur ing the initia l exposure mo n itori ng reveal
a n a i rborne co ncen trat io n a t o r above the act io n leve l b ut at or be low t he TW A , the Comp any shall
r epea t th e ex pos ure mo nit o rin g f or that ex pos ure gro up at l eas t eve ry 6 mo n th s . If th e PMN subs tance is n o t ma nufactured, processed, or used at all dur in g n g ive n 6 mo nt h ca lendar per iod, t he Company i s no t r equired to conduc t exposu r e monito r ing un t il ma nufac ture, processing, or use of1hc PMN subs t a n ce is resumed. Howeve r, cessation of manufactur ing, p rocessing and usc of- 19- the P:\1N substance for less than the 6 month period does not constitute grounds for postponement of the 6
. month deadline to condu<.:t exposure monitoring. (ii) If any representative samp les t aken during the initial exposure monitoring reveal an airbo rn e concent ration above the TWA, the Company sha ll repeat the exposure monitoring for that exposure group a t least every 3 months. l f the PMN substance is not manufactured, processed. or used at all during a given 3 month calendar period, the Company
. is



# . not required to conduct exposu r e monitoring until manufacture, procc:ssing, or use of the PM:'J substance is resumed
. Howe\'cr, cessation of manufacturing. processing and usc of the PMN

. . substance for less than th e 3 month period d oes not co n s titut e g rounds for postponement of the 3 month deadline to conduct expos ure monitoring. (iii) The Company may alter the exposure mo nitoring sc h edule from every 3 months to every 6 months for any exposure group for whom two consecutive measurements taken at lt:ast 7 days apa rt indi cate that t he potentia l exposure has decreased to the TWA or below, but is at or above the action level. Wh ere the PMN substance is manufactured, processed, or used in batches of duration less than 7 days, the 2 consecutive measurements may be taken at least 24



# . hours apart, provided that the measurements accurately reflect th e highest peak exposures and variabi lit y in expo s ure. (4) Term in ation ofMonitqring. (i) 

### If r ep resen tative samples taken d uri ng the initial exposure monit o rin g reveal an airborne concentration below the action level, the Company may discontinue m onito rin g for th at expo s ure group, except when additiona l exposu r e monitoring is required by paragraph (d)(5) of thi s New Chemical Exposure Limit sect ion .- 20- (i i) I f rcprcsenLative sampl es taken during the period ic monitoring rev eal that an airborne concentration , as i ndicated by at leas t 2 consecut ive mea s urement s taken a t least 7 days apart, arc below the action level. the Co mpany may discontinue th e monitor in g for that exposure grou p , except when additional monitoring is requi red by para grap h (d)(5) of thi s New Chemica l Exposure Limit section. Where th e PMN substance i s manufactured , proce sse d , or used in batches
or duration less than 7 days,' the 2 consecutive measurement s may be taken at leas t 24 h o ur s apart, provid e d that th e measurements accurate l y renec t the highe st peak exposures and variabil it y in exposure. (5) Additional Monitori ng. (i) For a previously monitored exposure gro up , the Co mp any sha ll , wi th in 7 day s
o f any of the events listed below in this paragraph (d)(S)(i), conduct the initial exposure monitoring followed by a ny periodic or addi tional exposure monitoring requi red 

### by subsection (d) of this New Chemica l Exposure Limit sect ion: (1)**ch~ng e**  in th e production vol ume , process, control equ ipm e nt , personnel
or work pract ices that may reasonably cause new o r additional exposures to th e PMN subs tan ce; (II) spi ll s, leaks, ruptur es o r othe r breakdowns occur that may rea so nably
cause new or addi tionnl exposures to the PMN substa nce ; and (Ill) whenever else the Co mpany ha s any reason to suspect a change that may rea so nably re s ult in new o r addit i onal exposures t o the P.\IIN s ubstance. (ii) I n no event is the additiona l exposu re monitoring rcquin:mcnt in paragraph (d)(S)( i) intend e d t o delay implementation of any necessary c leanup or other remed i al action. During any cleanup or remedial o per ations that may occur before co mm encing addit iona l exposure monitoring, the Compa ny shall e nsure that poten ti ally exposed persons u sc at lea st the respiratory- 2 1 - protection spec ifi ed i n subsectio n (c) for the mea su red airbo rn e co ncentration , or more pro tecti ve
r esp irat ory equ ipm ent deemed appropriate by th e bes t profess ional j ud g m e nt of a qualified cxpc 1i
. (6) Notification or Monitoring Results. (i) With i n 15 worki n g days after receipt of the results of any exposure monitoring required by this O rder, th e Company s hall notify eac h perso n wh ose exposure i s r epresen ted by that mon itoring. The notice s hall identify th e NCE L , the ex po sure moni t or in g r esu lt s, and 

### any correspond in g resp ir a t ory protect ion required by s ubsection (e). Affected person s shall be notificd in wri ti ng e ith e r indi v i dua ll y or by p os tin g the in fo rm ati on in a n appropriate an d accessible

0 0 location. (ii) Whe never the NCEL is exceeded , the written not ifi catio n r eq uired by th e prec edi ng paragraph shal l descr ibe th e action b e i ng tak en by the Company to red uce inhalation exposure to o r below th e NCEL, or shall refe r to a document avai lable to th e p erso n whic h**es** th e actions to be taken to reduce ex posure. (7) Exemptio n based o n Obje c ti ve Dat a. Where the Company has d ocumented and reliable object i ve data d emo nstra ti ng th at, even under wo rst -c as e conditio ns, emp loyee expos ure t o the**P~** substa nce will not exceed th e act i on leve l (defined in paragraph (d)( l )( i)) unde r the expected handl i n g procedures and cond it ions f or a spcci li e "expos u re gro up" (de li ned in**par~igraph** (d)(l )(i i)), th en tha t exposure g ro up is exe mpt f r o m thi s New C he mi ca l Ex pos ure Limit sect io n (except pa ragraph (d)(5) "A dd itio na l Monitoring " and subsection (f) · 'NCE L Reeord keeping'') and t he respirator r equi r ements in the P rotection in the Workplace sec tion of this Ord e r. Any such objective dat a m u s t acc ur ately charac t er ize actual emp loyee expo s ures t o t he PMN s ub s tan ce and must he ob t a in ed under condi ti o n s close ly r esembl in g th e types of materials, p rocesses, contro l methods. work pracli<.:cs
. and <.: nviro 1 unemal cond it ions in the Company ' s curren t workpl ace• 22
. operations v. ·ith lhc PMN substance. Examples o f objective data that may be used t o demonstrate that

_ emp loyee exposure will not exceed the action l evel, even under wors t case cond iti ons, inc lude information on the physical and chemical properties of the PMN substance, industry

- wide stud ies, and/or laboratory te s t results.
(c) Re s piratory P rotection
. ( l ) General. Whenev er the Company h as conducted exposure monitoring at a workplace in accordance wi th s ub section (d) of this New Chemica l Exposure Limit sec tion and the measured



### . . a irb orne concentration of th e PM 1 subs tance for any pe rso n who is reasonably likely to be**expos~d** to the PMN subs tanc e by inh a lation exceeds the NCEL, the Company s hall provide those persons the r espirators specifi e d in thi s subsec ti on (e) (ralher lhan the re s pirator( s) identified in the Protection in the Workplace section of this Ord er), and s hall ensure that the respirators are used (includ in g training, 

### fit tes ting , and maintenanc e) in accordance w it h O S HA and NIOSI I re spiratory pro t ec tion requirement s at 29 C FR 1910. 1 34 and 42 Cf<"R Part 84. Wh e n the Company has not yet
measu red the ai r borne co nc ent ra ti on of Lh e PMN s ubstance at a workplace in accordance with thi s New Chem ical Exposure Limit sec ti o n , the Compa ny shall comply with the respirator requireme nts in th e Protec ti on in the Workp lace sect io n of thi s Order at th at workplace. (2) .S.c lect i_on of Appropriate Re spi ratory Prote c tion. Afte r the Co mpany has conducted exp os ure mo nitoring in accordance with subsection (d) of this New Chemical Exp os ure Limit
sec ti on, the Company shall selec t , provide, and ens ure that persons who are reasonably likd y to bt: exposed to the PMN**t~b tancc**  by inh a lation usc, at a minimum , the respiratory protection which corresponds in the f o llowing t ab le to th e mea s ured airborne concentration (or a more protective
re sp ir ator w hi ch corresponds to a concentration higher than measured).Measured Concentration of PM!' S ubstan ce**~** NCEL**~** JO x NCEL**~** 25 

### x NCEL**~50** 

### x NCEL - 23

- PARTICULATE R ESP J RA TORTABL E Required Re s piratory Prot ec tion

No respiratory protection is required.
1 ) Any N J OSH-certified a ir-purif y in g clastomeric half-ma s k respira t or equ ipp e d with N I 00 (if oi l aerosols absent), R 1 00, or Pl 00 filter s (11) Any app r opriate NIOSH-ccnified NIOO (if oil aeroso ls absent). RlOO, o r P 100 filtering fnc cp i ccc respirator. [Note: for filtering facepieces, an APF of I 0 can only be ac hi eved if the i·espirator is q ualitativ ely or quant it atively fit tested on ind iv idu a l workers]. (111) Any N IO S H- certi ft ed ai r -p urif y in g ful l' facepi ece res pir ato r equipped with N I 00 (if oil**aerosol~** absent), R I 00, or PI 00 fil ters (IV) Any N IO S l 1-cert i lied negative pressure (demand) s upplied-air resp irator equipped wi th a**half-ma~k** (V) Any N IO S ll- certified ne gative pressu r e (de mand ) se lf-contained breathin g apparatu s (SC BA ) equ ip ped with a half mask. (J) Any NIOSH-certified p owe r e d air-purifying respirator equipped with a hood or helmet and H EP 1\ fi hers. (II) Any NfOSH -certifi ed powered a ir -pu rif ying respi rat or equ i pped w ith a loose fitting facepiece and HEPA filters. (lll) Any NlOSH-ccrlificd**continuou~** Oow s upplied -a ir**rc~pirator** equipped with a hood or helmet. (IV) Any N IO SJ )-certified**cont inu** **ou~** flow s upplied-air respirator equipped with a loose fillin g face pic cc. (l) Any NIOSH-ccrti fi cd air-p urif ying full faccpiccc respirator equ ipp ed with N I 00 (if oi l aerosols abscnl), R-1 00, or P -1 00 lihcr(s).**~** 1000 X**~CE L**  - 24

- (11) Any N J OSH-certiftcd powered air-pur i f y ing respirat o r equ ipped with 

### a tight-fittin g fa cc piecc (half or full facepiece) and equ ipp ed w ith H EP 1\ fi hers (II I) 1\ny N IOSH-ccrlified pressure -de mand or other po s itive pre ssure mode s upp li e d -air respirator equipped with a half-ma sk (JV) Apy NIOSH-certified negative p ressure (demand) s upplied

- air respi rato r equipped with a fu ll faccpiccc. (Y) Any N IOSll -ce rtifi cd co ntinu ous Oow s upp l ied-air respi r ator equipped with a ti ght

- fitti n g faccpiecc (ha lf o r full fac epiece). (VI) Any N IO SH-certilied negative pressure (demand) se lf-conta i n e d breath ing apparatus (SCBA) equipped with a hood or he l met o r a full foceplecc.. · - ( I

) Any NIOSH-certified p owered air purif y i n g full facepiece respirator eq uipped with l !EPA filters. ( JJ ) Any N I OSI J -cert i fied powered air-purifying respirator equipped with a ho od or h elme t* and NIOO ( if oil aerosols absent), RlOO , or PlOO tilters with evide n ce demonstrating protection level ofl, 000 or grea t er . * 

### [N ote to Pr og ram Mana ge r: Co p y and pa s t e th e 

## * and t h e foo t note b e low the tab l e wJ t cn se l ec ting thi s re s pirator
. ! ( 111 ) Any NJOSH-certi fi t.!d continuous now s uppli e d -a ir res pirator equipped with a fu l l facepiece. ( IV) Any**iJOSH c~rtilied**  continuous flow s upp lied -a ir re s pirator equipped with a ho od o r helme t with evidence demonstrating protection level of 1,0 00 or greater.* (Y) Any NIOSl !-certified s upplied-a ir respirator equipped with a full facep iece. *OS H A has assig ned 1\PFs of 1000 for certain type s of hoods and helmets wi th p owered air pur ifying respi r ators (PA PR s) o r supp li e d ai r r espirato rs (SARs) where the m an u fac turer can demonstrate adequate air now s to maintain pos itive pre ssure in s ide the hood or helmet in normal work in g conditions. However, the employer must have evidence provided by the respirator manufacturer that the test ing of these respirat ors demonstrates perform.ance at a l evel of protection of 1,000 o r greate r t o receive an APF of 1,000. This level of performance can best be demonstrated by performing a> 10 0 0 X NCEL (max. 10 , 000 x NCEL) - 25

- workplace Protection Factor (WP F ) or Simulated Workplace Pr otection F actor (SWPF) s tudy or equivalent testing
. Without testing data that d e mon s tr a t es a level of pr o t ec tion of 1 , 000 or greater, a ll PAPR s a nd SAR s with helm e t s /hood s a r e to b e t r eated a s loos e- fitting · fa c e pie ce respi ra tor s , a nd re c eiv e a n APF of 25.
Any NIOSH-ccrtified pressu r e-de mand or other positive press ure mo de (e.g
. , opl:rtlclosed ci r c u i t) se l f-co nt a in ed b r ·ca thin g a pp a r a tu s (SCBA) equipped with a h ood or helm e t o r a f u ll face p i ece . (3) Reductions in Re spi ratory Prote ct io n . After**appropr iat~**  re spi ratory pr o tecti o n has bl:<.:n $elected based on th e results of actual exposure monit o ring co nducted a t a workplace in ·accordance with subsec t io n (d) of this New Chemic"al Exposure Limit sec ti on: the Company s hall not . at that workplace, use the resp iratory protec ti o n required by the Prot ec tion in th e Workplace section of this Order (unless it i s the same as r equ ired by thi s New C h em ic a l Exposure Lim it section)
. Befo r e the Company may make any r ed ucti on in any r esp irat ory protection selec ted pu rs uant to this New Chem ical Ex po s ur e L i mit sec ti o n, the Co mp a ny mu st verify, by 2 consecuti ve measurements taken at leas t 7 d ays apart, th a t th e n ew r espirato ry protectio n is appropriate in acco rd ance with paragraph (c)(2). Where th e PMN subs tanc e is m anufac tu red, processed, o r used in batches o f duration le ss than 7 d ays, the 2**co~sccutivc** measurements may be taken at l east 24 hours apa rt. provided that the mea s ureme nt s accurate ly reflect the high est peak exposures and variab i lity in exposure. (4) Specia l Situations. ( i ) Measureme nt s Outs id e Quanti tat ion Limit s. When a va lue less than the I .QL of the unalytical method (as descr i bed in paragraph (c)(4)( ii)) is measured, the Co mp any shall estimat e potent ia l exposure using generally cstub li shcd and accepted stati s tic a l methods. If th e Company obta in s an ex posure monitoring sample that i s more than I 0% above t h e ac t ual UQL uf- 26 - the a nalytical method, the Company must ensure that its workers wear at l east a NIOSl J-cettificd supp lied -ai r r espira tor o p erated in pressure demand or othe r positive pressure mode and equipped with a tight-fitting full faccpiccc. Any reductions in this respiratory prot ec tion mu st comply with paragraph (e)(J). The Company may submit an improved analytica l method provided that it comp li es fully w ith subsection (c) of this New Chemica l Exposure Limit sect ion , includin g the verification requ ir ed by subsec tion (c)(3)
. (ii) C leanu p and Remedial Actions. During any specia l cleanup or other remedial actions that may occur before commencing additional exposure monitoring (as discussed in

. . paragraph (d)(5)(ii)), the Company shall ensure that potentia ll y exposed persons use a t least the respiratory protection spec ifi ed above in this subsection(<.:) for th e measured airbome
co ncentrat ion , or more protective respiratory equ ipm ent deemed appropriate by the best professional judgment of a qualified ex pen. (i) NCEL Reeordkeeping. (1) Whenever the Company e lects to comp ly with this New Chemica l Expos ure Li
. mit section rather than th e r espi ra tor requirements in the Protection in the Workplace section of this Order. the Company shall maintain the following records until 30 years after the date they arc created, and sha ll make them available for in s pect ion and copyi n g by EPA in accordance with section II ofTSCA: (i) A copy of the samp lin g a nd analytical methods used and continuing ev idence of their accuracy over time as r equired by sec1ion (c);-27- (ii) Records documenting compliance with th e ana l ytical method verification requirements of subsec ti on (c)(3), including copies of the signed**c~rtification** statement and the verification results ob tained by both laborator ie s; (iii) Records documenting either complia nce with the Good Laboratory P mctice Standards at 40 CFR Part 792, 

### or u se of 

### a laboratory acc redited by the A If 1/\ or another comparab le program approved in adv<mce in writing by 

### EPA. Where th e Company elects to not comply wi th TSC/\ GLPS, s uch records sha ll in clude the written accreditation from the 

### AIHA or th e written approval from 

### EPA. ( iv ) Reco rd s do c um en tin g all exposure monitoring dales, du ra ti on, an d resu lt s of each samp le taken; (v) Records documenting the name, address, work s hift, job c la ss ili cation , and work area of the person monitored and of all other pe rsons whose exposu res th e monitoring is intended to represent; (vi) Any conditions that might have affected th e monitoring re su lt s; (vi i ) No tifi catio n o f exposure monitoring results re quire d by para graph (d)(6); (vii i ) Records documenting any changes in the production, process: control equipment, personnel o r wo r k practices th a t may reasonably cause new or add iti onal**exposur~s** to the PMN**subs tanc~;**  (ix) Records documenting any spi ll s, Jen ks, ru ptu re s o r o th er breakdowns that may
cause new o r addi ti ona l exposure;

suhstancc; (x) The type o f respiratOI)' pr o tective dev ic es worn by the monitored person. i f any; (xi) Record s document in g any actio n s taken to mitigate exposures to the J>:'vlN- 28- (xii) Records documenting reliance on the ob jecti ve dat a exe mption in paragraph (d)(7), including: (A) the so urc e o f th e dat a, ( B ) protoco l s and re s ult s of any relevant testing or a nalysis, (C) a d escrip tion of the o pera ti on exempted and how the d ata demonstrate th at emplo yee exposures will not exceed th e act io n leve l , (D) o th er data r e leva nt to the operations , m a ter ia ls and employee exposures cove red hy th e exemption.



### HAZARD C OMMU NJCATIOJ\: PROGRAYf (a) Wri tte n HaZR rd C o mmuni cati on Program. Th e Compa ny s ha ll develop and impl e men t a written h'tLard communication program for the PMN su b sta nce in eac h wo rkplace
. Th e wr itt en prog ram will, at a minimum , de sc rib e how the requirements of thi s sec tion for labels, M S DS s, and othe r forms of warning ma terial will be sat i sfied
. The Co mp any must m ake the wr itt e n hazard
commun ica tion pro g ram ava il able, up o n request, to a ll employees, co ntr actor emp loyees, and their des i g na ted representatives. The Company may rely on an ex is ting hazard communicati o n prog ram , includ ing a n ex istin g program estnb li s h ed unde r th e O S HA Ha za rd Commun ication S tand a rd (29 CF R 1 91 0.1200), t o comply with this pa ra grap h provided that th e existing ha za rd
co mmunication program sati sfies the r equi r eme nt s of thi s sec ti o n . The writt e n program shall include th e following: (I) A I is t of c hemical s ubs tances known to be pre se nt in the work ar ea which are s ubj ect to a T SCA sect ion 5(e)**co ~nt**  orde r s i gne d b y th e Co mpan y or to a TSCA sec tion 5(a)(2) SNUR at 40 CFR Part 721, subpa rt E
. The list mu st be maintained in each work area where th e 

### PM N subs ta nce i s known to be pr esent and mu s t usc th e id en tit y provided o n the MSDS for th e substance r equired under paragraph (c) of thi s sec ti on. Th e li st may be comp iled fo r th e wo rkplace- 29-

or tor individual work areas. ll"th e Company is required either by**~nether** Order issued un der section S(e) ofTSCA, or by a TSCA section 5(a)(2) SNUR at 40 CF R Part 721, s ubpat1 E , to maintain a li st of substances, th e lis t s shall be combined wit h the list under th i s subparagraph. (2) The methods the Company will use to inform employees of the hanrds of non-routine tasks involving the 

### PMN substance (e.g., c leaning of reactor vessels), and the ha zards associated with the PMN substance contained in unlabeled pipes in th eir work area. (3) T he methods the Company will use to inform contractors of the presence of th e PMN substance in the Company's workplace a nd of the provisions of this Order if employees of the

. . 

### . cont rac tor work in the Company ' s workplace <md are rea so nably likely to be exposed to the PMN subs tance while in the Company's workplace.
(b) Labeling. ( I ) The Company shall ensure that each container of the subs tance in the · workp lace is labeled in accordance with this s ubparagraph (b)( I). (i) The label s hall , at a minimum, co ntain the following inf orma tion: (A) A statement of the health h aza rds(s) and precautionary measure( s), if any . id entifie d e it her in paragraph (f) of thi s sect ion or by the Company, for the PMN substance. (B) The identity by which the PMN substance may b e commonly recognized. (C) A state ment of the environmental ha za rd (s) and precautionary
mca su rc(s), if a ny, identified either in paragraph (f) of this sec ti on, or b y th e Company, f or the Piv1N**ubstanc~.**- 30- (D) A statemen t of exposure and precautionary measure(s), if any, idcntifitd**~ither** in paragraph (f) of this section
. or by the Company, for the 

### PMN substance. (ii) The Company may use signs, placards, process s hee ts, batch tickets, operating procedures, or other suc h**writ~en** materials in l ieu of affixing lahcls to individual stationary process containers, as l ong as the a lt ernative method identities the containe r s to which 

### it i s applicable and conveys in fo rm atio n specifie d by subparagraph (b)( l )( i) oft hi s section. Any wr itt en materials must be read il y access ib le to the employees in their work areas throughout each work sh i ft. (iii) The Company need not labe l portable containers int o w hi ch the Ptvf.\! substance is transferred from labeled containers, and whi ch are intended only fo r the immediate
usc of the emp loyee who performs**th ~** **tr ansf~** **r.** (iv) The Company shall no t remove or deJace an existing label on containers of the PMN subs t ance obtained from perso n s outs i de the Co m pany unless the container is immediately re-labeled with the i nformation specified in subparagraph (b)(l )(i) of this sec ti on . (2) The Company sha l l ensu re that each container of the substance leaving its wo rkplace for distribution in commerce is la beled in accordance with thi s subparagraph (b)(2). (i) The label shall, at a minimum, contain the fo ll owing inf ormation: (A) The information prescribed in subparagraph (b)(l)(i) ofthis section. (B) Tht.: nam e and address of the manufacturer or a responsible party who
can provide additiona l information on 01e substance for hazard evaluation and any appropriate
e mergency procedures. (i i) The label sha ll not conflict w ith the requirements of th e H azardous Materials Transportation /\ct ( 18 U .S.C , 1801 ct. seq.) and regulations iss u ed under that Act by the 

### Department of 

### Transportation.- 3 1 - (3) The labe l , o r a lt ernat i ve forms of warn in g, s hall be legible a nd prominently d isplayed. (4) The labe l , o r a lternative forms of warning, shall be printed in E ng! ish; however. the information may be r epeated in othe r languages. (5) If the label or alterna ti ve form of wa rnin g is to he applied to a mixture co ntainin g the PMN substa nce i n combination with any other substance that is e ither subjec t to a n ot her TS CA
sec ti on S(e) Order appl icab le to the Company, o r sub j ect to a TSCA sec tion 5(a)(2) SNUR at40 CF R Part 72 1 , s ubp ar t E. or defined as a " ha7..ardous chemical" under the OSHA I Iazard Communicatio n Standard (29 CfR 1 900 .1 200), th e Company may prescribe on the labe l , MSDS.



### . . or altern ative form of warni ng, the me as ures to co ntrol wo rk er exposure or env ironm ental r e l

ease whic h the Company determines provide tl w grea test degree of protection. 1 l owever, s h ou ld these contro l mcnsurcs differ from the app licable mea su res required under this Order, th e Company must seek a deter mi na tion of eq uiv a le ncy for s u ch a lt e rn a tiv e co ntr o l meas ur es purs uant to 40 CF R 721.30 before prescrib in g th e m under thi s subparagraph (b)(S). (6) I f the Company becomes aware of any s ig nifi cant new informat i on regarding the hazards of the Pfvf l\ subs tance o r ways to pro tect against th e haza rd s , this ne w information must be added to the label wi t h in 3 months from th e time the Co mp a ny beco me s aware of the new infomtat ion. If th e P J\IfN substance is not bei n g m anufactured (de fin ed by s tatu t e to in clude import), processed, or useu in the Company's workp lace, the Co mpany mu s l add the new inf011n atio n to the l abel befo r e the PMN substa nce is reintroduced into t he workplace
.- 32

- (c) Materia l Safe_ty Data Sheets. ( I ) The Company must obtain o r**d~vdop** an l SDS for th e PMN substa nc e . 

### (2) The MSDS s hall cont ain , at 

### n mi nimum , th e following inform atio n: ( i) The identity used on th e container labe l of the 

### P MN su b stance under this section. and , if not claimed confiden ti a l, the chemical and common name of the PMN sub s tance. Jfth e c h em ical and common name s a rc c la im ed confidential, a gene ric c h emica l n a m e must be used. (i i) Physical and c hemical characteristic s of the substance known to the Company ,
. . (e
. g . , va po r pressure, flas h point)
. (i ii ) The physical hazards of the substance known to the Company, including the potential for fire, exp l osion , and reactivity. (iv) The poten tia l hum an ha7..ard s as s pecified i n para gra ph (f) of this sectio n . (v) Signs and symptoms of exposure, and any m ed ical condi ti on:; whi ch arc expected to be aggrava t ed by exposure to the PMN s ubstance known to th e Compa n y . (v i) Th e prim ary**rout~s** of exposure to the PMN substa nc e . (v ii ) Precautionary measures to contro l worker expos u re and/ or env ironmental release required by thi s Order, or alternative con trol meas ures whic h EP 1\ has determ i ned under 40 CF R 72 I
. 30 provide subs t cm t iall y the sa m e d eg r ee of protection as the identified control measures. The MSDS must identify any**~ew** Chemical Exposure Limits specified in paragraph (b) oflhe New Chemical Exposu r e Limit sec t ion of this Order and must contai n th e information specified in the gra du a t ed re s pirator t ab le in paragraph (c)(2) of the New C he mical Exposure L imit sec ti o n . (vii i) Any generally ap pl icab le precautions for safe handling and us e of the PMN suhswnce which are known to the Company, in cluding appropr ia t e h yg ien i c practices, protective- 33-

measures during repair and maintenance of contamin ated equipment, and procedures for response to spi ll s a nd leaks. (ix) Any generally appl icable control measures which arc known to the Company, such as appropriate eng in eer in g con tr ols, wo rk p r act ices, or per so nal protective cqt dpment. (x) Emergt;ncy first aid procedures kn own to the Company. (xi) The date of preparat ion of the MSDS or of its last revision. (xii) The name, address , and telephon e number of the Company or another responsible party who can prov id e add i tional in f ormation on the chemical s ub s tance and any

. . . . appro priate emergency procedures. (3) Tfno relevant information is found or known for any given category on the MSDS, the Company must mark the MSDS to ind i cate that n o app li cable information was f ound
. (4) Where multip le mixtures containi n g the PM!\ substance have s imil ar compositions (i.t;
.. the chemit;a l ingred ients ar e essentia ll y th e same, but the specitic compos itio n varies fro
. m mixture to mixture) and s imil :u hazards, th e Company may prepare one MSDS t o app ly to all of the se multiple mixtures. (5) J f the Company becomes aware of any significan t new information regarding th e hazards of the PMN substance or ways to protect again s t the hazards , this new information must be added to the MSDS within 3 months from the time the Company becomes aware of the new information. If the PMN s ub s tance is not being manufactured (define d by statut e to include imp ort), processed, or used in the Company's workpl ace , the Company must add the new in formatio n to the :v!SDS before the**P.Y~** s ub stance is reintroduc ed into the workplace.- 34

- (6) T he Co mpany mu s t e nsu r e th at per so ns recei v in g th e PMN s ubstanc e fi· om th e Co mp any are provide d an appropriate 

### MS DS with their i ni ti a l shipmen t a nd with
. the fir st sh ipm ent afte r an 

### MSDS is r evise d. The Company may e ith er prov ide the 

### M S D S with th e s hipped
con tai n ers or se nd it t o the person pri o r to o r at th e time of s hipment. (7) The Co m pany mus t maintain n copy of the 

### MSDS in its work place, a nd mu s t ens ure that it i s r eadi ly acce ss i b le during eac h work s hi ft to e mpl oyees wh en they arc in their work areas . (8) The MSDS may be kept in any f01m. including as o per ati ng**proc~durcs,** and may be designed to cover g roups o f s ub s tan ces in a wo rk ar ea wh e r e it m ay b e more a pprop ri ate t o address

. 

### . . 

### - the p otenti al h azard s of a process r at her th a n individua l sub s tances. Howeve r , in all**c~ses.** th e
r eq uired i nfom1ation m ust b e p r ov ided for t h e 

### PMN s ubstan ce and mu st be r ead il y accessible du ri ng each work s hift t o employees wh e n they ar e in their work areas . (9) The 

### MSDS mu s t be p rint ed in Eng lis h ; ho weve r, the informat io n m ay be repeated in
o th er languages.
( d) Em nLoyee In fo r mation a nd**Tq~ inin** **u.** The Company rnu s l**ensu ~**  th at e mpl oye e s are provided
wit h in form ati o n and trainin g on the PMN s ub s tance . Thi s informa ti on and training must be provided a t t he t i me of eac h emp l oyee's ini tia l ass ig nme nt to a work area con ta in ing the PMN subs t ance a nd \ • V

hcm:ver th e PMN subs tanc e i s introduced in to the em plo yee's work area f or the fi rs t tim e . ( I ) The i nfo r mation prov i ded to emp loyees und e r this para graph s h all in clude : (i) Th e requi remen ts of thi s sec ti on. ( ii ) Any operation s in th e work ar ea whe re th e PMN s ub s tanc e is prese nt.- 35- (iii) The loca tion and availability of the written h aza rd commun ication program required under paragraph (a) o f this section, including t he list of substances required by subparag raph (n)( I) of thi s sec tion and MSDSs required by paragraph (c) of thi s seclion. (2) The training provided to em p loyees shall incl u de: (i) Methods and obse rvati ons that may be used t o detect the presence or re lease of the PMN s ub s tance i n or from an employee's work area (such as exposure monitoring conduc t ed by the Company, continuous monitor i ng devices, visua l appearance, or odor of the substance when being re lea se d ). (ii) The po tential h uman health hazards of the PMN s ubstance as specified in paragraph (f) of thi s section. (iii) T he measures employees can take to protect them selves and the environment from th e PMN substance, including .speci fie procedures the Company ha s implemented to protect employees and the environment from exposure to t h e PMN substance, inc luding appropr iate work practices, emergency procedures, per so nal protective equ ipmen t , engineering controls, and other
measu r es to con t rol worker exposure and /o r environ m e n ta l rdea sc r equired under this Order, · or alternative control measures which EPA h as determined under 40 CFR 721.30 provide the same degree of protecti o n as the spccit i ed contr o l measu res. (iv) The requirements of the hazard communication program developed by the Company under th i s section, including an explanation of the labeling system and the MSDS required by this section and gu idance on obtaining and u s ing appropriate hazard information.

### - 36

- (c) D e Minimis Concentrat i ons. The require m ents of th is Ha zard Communicat ion sect io n do not apply to qu ant iti es of th e PYIN subs tan ce that are (1) present in th e work area on ly as a mixture and (2) at a concen tration not to exceed 1.0 percent by weigh t o r volume (0. I percen t by weight or vo lum e if th e PMN sub stance ·is id ent ifi ed as a potential ca rcino ge n in paragraph (f) of the H aza r d Com m unicatio n Program section of this Order). This exemption is not available 

### if the Company has re aso n to believe th at , during in te nd ed ac ti vities, th e PMN subs t ance in the mixtme ma y be reconcentrated above the 1 .0 or 0.1 percent level, whichever applies. l f this Order contai ns (I) New Chemi ca l Exposure Limit s provis io n s th at spec if y a NCEL conce ntr ation l ess th an the de



### . . . minimis concentration**Sp~;!cified** here, or (2) R e l ease to Water provisions that prohibit release to water o r s p ecify in- stream concentration ("N") less than the de minimi s concentration spec ifi ed here, then this de minimi s exemption docs not apply to those provisions
.
(f) Human Health**Pr ef~u** **ti ary**  S tatements. The following human health precautionary statements shall appear on each label as specified in paJagraph (b) and th e MSDS as specified in parag raph (c) of thi s sect i o n: ( 1 ) Hum an health hazard statements. This substance may cause: ( i ) respiratory compl ications. (2) II uman hazard precautionary statements. When using this substance: (i) avoid b r ea th ing the s ub stance. (ii) use respiratory protection, or maintain wo r kplace airborne concentrations at o r be low an 8-hour time

- we igh t ed ave rage of 5 mg/m 3

.- 37- (3) The human precau t ionary statement on the label prepared pursuant to paragraph (b) of this sect ion must be followed by the statement: "Sec the MSDS for details."' (g)**Exi~ting** ltazard Communication Program. The Company need not take addit io nal actions i f exis t i ng programs and procedures sat isfy the requirements of this section.

M ANUFAC T U RI NG (a)( I ) Prohibition. The Company shall not cause, encourage, or suggest the manufacture (which



### . . 

## . includes import) of the 

### PMN subs t ance by any other person. (2) Sunset Follow i ng SNUR. Subparagraph (a)( I) shall expire 75 days after p r omu l gation of a final s i g nificant new usc rule ("S:"JUR") governing the PMN s ub s tance under se ction 5(a)(2) ofTSCA unless the Company is not i fied o n or before that day of an action in a Federal Court · seeking judicia l review of the SNUR. If the Company is so notified, subparagraph (a)( 1) s hall not expire until 

### E PA notifies the Company in writing that all Federal Court actions involving the SNUR have been resolved and the va l id i ty of the SNUR affir me d
. (3) l'\otice of SNUR. When E PA promulgates a tina! SNUR for the PI\1N substance and subparag raph (a)(l) expires in accordance with subparagraph (a)(2)', the Company shall notify eac h person whom it causes, encourages . or suggests to manufacture the PMN subs tance of the existence of thc SNUR
. (b) The Company shall not manufacture the P MN substance other !han as an- 38- PROCES l NG Th e Co mpany s hall not process th e P\tfN s ubstance o th er than as an

lJSE The Company s hall not usc the PMN substance other than as an

DI ST RIB UT I ON (a) Expo r t Notice Requirem ent. No later than the date of distr ibu tion, the Company shall no tif y in
wr i tin g any per son to whom it di s tribute s the P:VtN s ub s tance that, due to the i ss uance of this Conse nt Ord e r under sect ion 5(c) ofTSCA, the PMN s ub s tance is s ubject to the export notification requiremen t s of T SCA section 12( b) and 40 CFR P art 707 Subpart D
. Such no ti ce s hall contain, in the form in which it a ppear s in this Con se nt Order, th e follow in g information: (l) the PMN number, and (2) e ither (A) the specific che mi cal id enti ty o f th e P:vtN subs tan ce, o r ( B ) if the spe cific chemical identi ty**s** confidenti al, the ge n eric chem ical identi ty.
(b) Distributi oQ Requirement s . Except afte r the PMN has been comple tely r eac ted , or as provid ed in parag raph (c), the Co mp any sha ll distribute the PMN substa nc e outside th e Co mpan y, o th er than f o r di s posal, on ly to a per so n who has agreed in writin g prior to the date of distribution, to : ( 1) Noti f y in writing an y pers o n to whom it di s tribut es th e PM N substance that , due to the iss uance ofthi::; Con::;t:nl Ord er under sec ti o n 5(e) ofTSCA, the PMN substance is subject to the expor t notificati o n requirem ent s ofTSCA section 12(b) a nd 40 CF R Part 707 Subpart D. S uc h notice shal l co nt a in , i n the f orm in which it appears in this Consent Order, th e f ollowing

### - 39- information: (1) the PMN number, and (2) either (A) the spec ific chemical identity of the PMN substance, or (B) if the speci fie chemical identity is confidential. the generic chem ical identity. (2) Co mply with the same requirements a nd restriction s required of the Company in the Protection in the Workplace and the New Chemica l Exposu r e Limit sections of this Order. (3) Cumply with thl! same requirements and restrictions required of the Company in the Hazard Commun ication Program sect ion of thi s Order. (4) Not use th e PMN s ubstance other tha n as an [expansive additive for ceme n t].
(c) Temporary Tran s port and Storage. No twithsta ndin g paragrap h (b), the Company may distribute the PMN substance outs ide the Company for temporary transport and storage in sea led containers provided the following three condit io ns nrc met: (I) Subsequent to a ny s uch exempt tempo rary transport or storage o f sca l ed con tainers, the PMN**substu c~.:**  may be distributed only to the Company or a person who has give n the Company the \"'Iitten agreement r eq uired by paragraph (b). (2) Any human exposu r e resultin g from opening the scaled conta in e rs a nd removing or washing out the PMN substance may occur o nl y whi le the PMN subs tance is in the possession and control of the Company o r a person who ha s g iven the Company the written agreement required by paragraph (b). (3) T h e sealed containers mu st be labeled in accordance with paragraph ( b)(2) of the Hazard Communication Program sect ion of this Order.
(d) Recipient**~on Comp** **lian ce.**  If, at any time after commencing distribution i n co mmerc e of the PlviN suhstancc , the Compa ny obta in s knowledge that a r ecipien t of the subs tance has failed t o- 40- com.ply with any of the conditions s pec ifi ed in paragraph (b) o f thi s Distribution sectio n or, after subparagraph (b)(2) expires in accordance with subpa ra graph (e)( l ), ha s engagt:d in a sign ific an1
new use of th e PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a sign ifi ca nt new use notic e to EPA, the Company sha ll cease supplying th e substance to that recipient, unl ess th e Company is able to document each of the f ollowing: (I) That the Company has, within 5 work in g days, not it ied the recipi e nt in writ in g th at the recipient ha s fai led to comp ly with any of the cond iti o n s specified in paragraph (b) of this Distribution sect io n , or has engaged in a significan t new use of the PMN substance without

. . submitt in g a significant new use notice to EPA. (2) Tha t, within 15 working day s of notifying the recipient of the noncompliance , th e Company received from the recipient, in writing, a statement of assurance thot the recipient is aware o f the t erms of paragraph (b) of tliis Di st ribution section and wi ll comply w i th those terms,
or is awa r e uf the term s uf the s i gnificant new use rule f o r the PMN substance and w ill not engage in a sign ifi cant new usc without submitt ing n s ignificant new use notice to EPA
. (3) If , after receiving a statement or assurance from a r ecip ient und e r subparagraph (d)(2) of this Distribution sectio n. the Co mpan y obtains knowled ge that th e r ec ipi cn1 has failed to comply with any of the conditions spec ifi ed in paragraph (b) ofthis Distribution sec tion , or has engaged in
a sig nificant new use of the PNfN substance without s ubm itt ing a s ignificant n(!w use notice to EPA, the Co mpany s hall cease supplying the PMN substance to that recipient, s hall notify EPA of the tailure to comply, and s hall re su me supply ing the PMN substance to that r ecipient only upon wri tt en notification from the Agency.- 4 1 - (e) Sunset Following SNUR. ( I ) Subparagraphs ( b)(2), (b) 4) of this Di stribu tion sec tion shal l
ex pire 75 days after pr om u lga tion of a fina l SNUR f o r th e PMN**~stance** under sec t io n 5(a)(2) of TSCA , unless the Co mpany is no tified on o r before th a t day o r an action in a Federal Court seek in g judicial review of th e SNUR. If the Company i s so n o ti fied , s u bparag raph ( b) (2) of this Di strib ution**se~t n**  sh a ll no t cxpire until EPA n otifie s the Compa ny in writi ng that a ll Fed eral Court actio ns in vo l v in g the S0JU R hav e bee n reso lved a nd th e valid it y of th e SNUR affi rm ed
. (2) When E P A promulgates a fin a l Sl\UR f o r the PMN substance a nd su bparagra ph ( b)(2) of thi s Distribution sectio n ex pire s in acco rd ance w it h su bp a ragra ph (c)( I ) , th e Co mp an y sh all not if y each

. 

### . . . person t o whom it dis tri but es th e PMN subs ta nce of the exi ste n ce of th e S 1 UR. Suc h noti fi cati on must be in writ i ng and mu s t spec ific a ll y includ e all li mitations cont ain ed in th e SN UR which are defined as significan t new use s . and wh ic h would inv o k e s ign ifi ca nt new use n o tification to E P A f o r the P tv1N substance. Such not i ce mu s t also reference th e publi catio n of th e SNU R for th is PMN s ub s tanc e in e ith er th e F e de ra l Re g i st e r o r th e Co d e of fe d era l Regu lations. After pr omulgat ion of a SNUR and ex pir ation of s ubparag rap h (b )(2), s uch notice ma y subs ti tu te fo r the wri tt en ag ree me nt re qu ir e d in th e intr oductory clause o f paragraph (b); so th at, i f the Co mpany provides suc h notice to th e pe rso ns to w hom it distribute s the PM;-J s ub s tan ce, th e n t he Company i s n ot required to ob t ain from s uch perso n s th e wri tte n ag r eeme nt s pe c i fie d in pa ragraph (b).- 42- 111. R EC ORDK EE PI NG (a) R eco rd s. The Co mpan y s hall maintuin the foll ow in g reco rd s unti l 5 years a fter t he dat e they
ar

c create d and s h all mak e th c ! n available for inspection and copy i ng by 

### EPA in accordance with
sec tion ll of TS CA : (l) Exemp t ions
. Records documenting th a t the PNf:\l substance d id in fact qua lif y fo r a n y one or m o re of the exemptions described in Sec ti on I , Par ag raph (b) of this Order. Such r eco rd s mu · t sa ti sfy a ll the s tatutor y a nd r egu l atory recordkecping requirements applicable to the**exc mp** **on** be in g claimed by th e Company. A ny amounts or batches of th e PMl\ s ub s tance

. . . e li g ib le for the expo 11 only exe mption in Sec ti on I, Parag raph (b)( I ) o f thi s Order are exempt from
a ll the r equir e m en t s in this Reco rdk ec: p in g sec tion , if the Co mpan y maint a in s, for 5 years from th e date of th eir c r eati on, copies of the export labe l and expo rt notice t o 

### EPA, requ ired by TS CA sections l2 (a ) (l)(B) and**2(b~,** r espect i vely. Any amounts or batches of th e 

### PMN subs ta nce
e li g i b le f or th e research and development exem ption in Sect ion I, Para g raph ( b)(2) of thi s Ord er arc exemp t fr om all the requi r ements in thi s Recordkeeping sec tio n . ifthe Company maintains, for 5 yea r s from the date o f the ir creation , th e r ecords req uir ed by 40 C fR 720.78(b). For any amounts o r ba tches o f the PM:\1 su b stance c l aimed to be elig ibl e for any other exe mpt i on described in Section 1, P a rag raph (b) o fthi s Ord e r, the Company s hal l keep r eco rds d e mons tr at in g q ua li iicat i on fo r that exemption as wdl as the r eco rd s spec ifi ed in paragraphs (2) and (3) below, but i s exem pt from the ot h er r c cordke ep in g requ irem e nt s in thi s R ecord ke epi ng secti on; (2) Records d oc um e ntin g th e manufacture (wh i ch includes import) vo lum e of the 

### PM
. subs t ance and th e correspondi
. ng dates of manufacture: (3) Records documenting th e n ames and add r esses ( includi ng s hipm e nt destination address, if different) o f a ll persons ou t side the site of manufacture (w hi c h includ es imp ort) tv- 43

- whom th e C om pan y directly se ll s o r tran sfe rs the PMJ\ s ub st ance. the date of each sale or tr a ns fer. and the quantity of the substa nc e sold or transferred o n such date; (4) Re co rd s documenting the address of all s ite s o f manuf acture (w hich includes impo rt ), proce ss ing , and u se ; (5) Record s documenting e s tablishment and implementation of a p rogra m fo r the u se of any applicab l e perso na l protective equ ipm e nt requir ed pursuant t o the Protection in the Workplace
sec ti o n of thi s Order: (6) Records required by pa ragraph ( f)
. of the New Chemical Exposure Lim it s sec ti on of**~** 

### . .. 

# . . thi s Order, if applicable; (7) Record s documenti n g es tabli s hment and impl e mentati on of the hazard communication prog ram required by the I Ta za rd Co mmunic ation Pr ogram sect io n o f this Order: ( 8 ) Copies of labe l s required under th e H azard Com muni ca tion Pro g ram se ction of thi s Orde r: (9) Co pie s of \1 a te ri al Safe ty Data S h eets r equ ired by th e H aza rd Co mm un ication Pro g ram secti on o f this Order; ( I 0) Records documentin g comp l iance with any applicable manufacturing , processing.
use, and di s tributi o n restr i ctio ns in th e Manufacturing, Processing,**~se ,**  and Di s tr ibution sec ti ons of this Order, in cluding distributces' written abrrecment to compl y w ith the Di s tribution sec ti on of thi s Order; (II) Copies of an y Tr a n sf er D oc ument s and noti ces r equired by th e Suc cess or Li abi lit y section of th is Order
. if appl**ic bl** **~;** and, ( 12) The Compa ny s ha ll keep a copy of thi s. Order at each o f its s it es where the PM N substance i s manufa c tured (whic h i nclud es**imp t1** **.**- 44-

(b) · Apnlicahiliw. Th e provisions of th is Recordkeeping Sec tion are applicable only to ac ti vities of the Co mpa ny and i ts Contrac t Manufact ur er , if appl icab le, and not to activities of the Company's custo mers.
(c) .OMB Control Number. Unde r the Pap e rwork Reduction Act and it s re gula ti ons a t 5 CFR Pa rt 1320, pa rticularly 5 CFR 1320
. 5(b), th e Compa ny i s not required to respond to this ' · collection of



### . in forma ti on" unless this Order d i sp lays a cunently va li d contro l number from the Office of

. .. . .. Manage m e nt and Bu dget ("OMB"), and l::P 1\ so info rm s the Company
. Th e · · collection of informatio n " r eq uired in this TSCA §5(e) Consent Order has been approved under currently val id OMB Co ntrol N umb er 2070-0012.

IV. REQUESTS FOR PRE-11\SPECTION I l'iFORMAT IO N (a) EPA's Request for Inf ormation. Pursua nt t o sectio n 11 ofTSCA and 40 CFR 720
. 122, EPA may occas ion al ly conduct o n-s i te comp li a nce inspections of Co mpany faci lit ies and conveya n ces associated with the PMN substance. To facil it ate such inspectio ns, EPA pcrso J mcl may contact the Company in advanc e t o request inf onnation pert i nent to the sc hedu lin g and conduc t of such i n s pec ti ons. Suc h reque sts may be written or oral. The typ es of informati o n th at E PA may n.:qul!st include, but arc no t limited to, the follow in g: (I) Expected dates and ti me s when th e!**PM~** substance wi ll be in production within the
s ubseq uen t I 2 mon ths : (2) CuJTen t wo r kshift schedules for workers who a r c involved in ac ti v iti es associated with th e PMN s ub stance a nd may reasonably he exposed to the Pl vfN substance:- 45- (3) Current job titles or categories for worke rs who are involved i n activities associat ed wi t h the PMN s ubs tance and may reasonably be exposed t o the PMN substance ; ( 4) Existing exposure monitoring data for workers who nrc involved in ac ti vit i es
assoc iated with the PMN substance and may r easonably be expos ed t o the PMN s ub s t a nce; (5)**R~cord s**  required by the Record keeping section of this Order; and/ or. (6) Any oth er information rea sonab ly related to determinin g com pliance w i th this Order or conducling an inspection for that purpose.
(b) Company's R espo nse. The Co mpany sha ll respond to suc h requ es ts within 

### a re aso n ab le period of time, but in no event l at er th an 30 da ys after receiv in g**EP~** 's request. Whe n re quested in wr i ti ng by EPA, the Company's r esponse shall be i n wr i ti n g. To t he ex ten t th e information is known to o r reasonably ascertainable by the Company a t th e time of the r equest, the Company's respon::;c sha ll demons trate a good faith etfort to pr ov id e reasonably accurate and detailed an swe rs to all of EPA 's r eque s ts.
(c) Confident ia l Ousiness Information. Any Confidentia l Busines s Informati on ("CBI " ) that the Company submits to EPA pursuan t to par agraph (b) s h a ll be protecte d in accordance w ith 

### § 14 of TSC/\ and 40 CfR Part 2.- 46 - V. SUCC ES S OR LIABILITY UPO N TRA NSFE R OF CONSENT ORD E R (a) Scone. This sect i on sets forth th e prol:edures by which the Company's rights and obligations
u nder thi s Orde r m ay be t ra nsfe rred when th e Company trunsfers i ts intere s ts in the Pl\1N substance, includin g the right to m anuf actu r e the PMJ\ subs t ance. to ano th er person outs ide th e Company (the "Successo r in Interest").
(b) Relmion of Transfer Date to otice of Commencement ("NOC"). (I) Before NOC. lf the transfer from the Co m pany t o the Successo r in Interest is effective



### . . before EP A r ece ive s a notice of commencement of m anuf actu r e or im po rt (' 'NO C") fo r the PMN substance from the Company pursuan t 10 40 CFR 720 .1 02, the Successor in Interest mu st submit a new PMN to EPA and comp ly fully with Section S(a)( l ) ofTSCA and 40 CFR part 720 before commencing manufac t ure (which includes import) of the PMN subs tanc e. (2) Afte r NOC. I f th e tr a n sfer from the Company ( o th e Successor in Interest is effective after EPA rece i ves a NOC, th e S u ccessor in In terest shall comply w ith the te 1 ms of this Order and shall not be r eq u ired to su bmit a new PM N to EPA
. (c) Dcl.initi
. ons. T he following definitions apply to this Successor Liability sec t ion of the Order: (1) "Successor in Interest" means a person outside the Company who has acqui r ed the Co mpany's full in teres t in the righ t s to ma nuf acture the PMN substa nce , including a ll ow ne rship rights and legal li abil i ties, tl u·ough a transfer document signed by the Company, as tran sferor, and the Successo r in Interest, as tr ansfe r ee. The term exc lud es persons who acqu ire less than the full interest of the Compan y in the PMN subs tan ce, such as a licensee wh o has acqui r ed a li mited license to the patent or manufacturing rights associated wi t h the PMN substance
. A Successor in- 47-
Inte rest must be incorporated. li censed, o r d oing bu s in ess in the Un it ed S t at es i n acco r dance with 40 erR 720.22(a)(3) and 40 CF R 720.3(z).



# . 0) ' · Tra n sfe r Document'" means the legal in st rument(s ) u sed to co n vey the int e rests in the PMN subs t ance, including the ri g ht
. to manufacture the PMN su b s tan ce, from the Co mpan y to th e Successor in Intere st.
(d) Notices. (l) Notice t o S u ccessor in In te res t. On or before the effec ti ve date of th e transfer. the Company shal l provide t o th e S u ccessor in lnl erest, by reg i stered mail , a copy of th e Co n sent O rde r and the "No ti ce of Transfer" document w h ich is in corpo ra ted by refe re n ce as Attachment B to this Order. (2) No tic e to EPA. W ith in I 0 business days of th e effective date o f th e t ransfer, the Company sha ll , by reg i stered m ai l. s ubmit t h e f ull y executed Not ice o f Tra n sfe r d oc ument to E PA at:

Postal Mail Address U.S
. Environmental Protection Agency
J ew Chem i cals Management B ranc h (7405M) 1200 Pennsylvania Ave nue , N.W. Washington, D.C. 20460- 48- Alrernntively, the document may he submitted

_ by cou ri eG U.S. Environmenta l Protection Agt!ncy New Chem ic a ls Management Branch (7405M) 1201 Constitution Avenue , N.W. Wushington. D.C. 20004 (3) Transfe r Document. Copies of the T ran sfer Document mu st be maintained by th e S uccessor in Jnterest at its**pri~cipal** place of business, and at all sites where the PMN substance is manufactured. Copies of the Transfer Document must also be made available for inspection pursuan t to Sectio n 11 ofTSCA, must state the effective date of transfe r , and must contain provisions which expressly transfer liability for the PMN substance under the terms of this Order from the Company to the Successor in Int erest.
(e) Liab ilit y. (I) The Company s hall be liable f o r compl iance with the requirements 

# or this Order until the effect iv e date of the transfer described above. (2) The Successor in Interest shal l be liable for comp li ance with the requiremen t s of' this Order eiTect i ve as of the date of transfer. (3) Nothing in thi s scc ti on shall be construed to proh ibit the Agency from takin g enforcement action agai nst the Company afier the effective date of th e transfer for actions taken, or omission s made, during the time in which the Company manufacwrcd, processed, used, distributed in commerce, or disposed of the PMN substance pursuant to the term s of this Consent Order.-49

- VI.
. \10DIFTCATION AND R EVOCA TIO N OF CONSENT ORDER The Compa ny may petition EPA at any time , based up on new i nformation on the hum an health o r e n vi ronmental effects of, or human exposu r e to or en vironmenta l relea se of, the PMN substance, to mod if y or revoke substa nti ve provisions of thi s Order: The exposures and ri sks identified by E P A during its review of thL: P.tvfN substance and the informat ion EP I\ determined to be necessary to evaluat e th ose expos ures and ri sks are de sc ri be d in th e preamb l e to this O rd e r . H owever, in
. detcrmining whether to am end o r r evo ke thi s Order, EPA will consider a ll re l evant information availab l e at th e ti me the Agency ma ke s th at determination, includ ing. w here approp ri ate, any reassessmen t of th e test da ta o r other inform ation th at su pp o rt s the fi ndin gs in th is Order. an exa min a ti on of new test d a t a or other information or analysis, and any othe r re levant infom1atio n. EP I\ w ill i ssue n modi ti cation o r r evocation i f EPA determine s that th e act i vi ti es propo se d therein will not present a n unreasonable risk of injury to h ealth o r**tl~ e**  environme nt and will not result in s ign i ficant 

# o r

substantial human exposure o r subs tan ti al environmental release in the absence of da ta s uffi c ie nt to pe rmi t a r easo n ed eva luation of the hea lth or en vironmental cffL:(; tS of the P:\111'\ substance. In add it ion . the Company may petition E PA a t any time to make other modifications t o th e language of thi s Order. EPA w ill issue s uch a modification i f EPA det ermin es that the modifica t ion i s useful, approptiatc. and consistent with t he st ructm c and i nt en t o f t h i s Order as i ssued.-50- V.II. EFFECT OF CONSENT ORD E R (u) Waiver. R y consen tin g to the e ntry of this O rder, the Company wa iv es its ri gh ts to tile objections to thi s O rde r purs uan t to sec tion S(c)( I )(C) ofTSCA, t o rece i ve se rvi ce of this Order no lat e r than 45 days befo r e the end ofthe review period pursuant to sec ti o n 5(e)(l)(B) ofTSCA, and to challe n ge th e va l idity ofthis Onkr in any**subs~ quent**  act ion. Consenting to the e11try of this Order, and ag r ee in g to be bound by its terms , do not co n st itute an ad mi ss io n by t he Co mp a ny as to t he fac t s or conclusions und erlying the Age ncy's d ete rm inations in this proceeding. T his wa iver docs not affect any ot her rights that the Company may h ave under TSCA.
(b) C BJ Br ackets. By sign in g this Order , the Company r epresen t s that it has caref ull y rev i ewed th is document and hereby agrees th at all in formation here in th at is clai m ed as co nf idential by the Company ( p er section 14 o fTSCA, 40**C~R** Part 720 Subpart E, a nd 40 CPR Part 2) is co rrectly identified within brackets and that any inf ormati on that is not brackett!d is not claimed as con fidential. To make th is document available for pub l ic v iev .. •i ng, EP/\ wi ll remove on ly the i nform a ti on co nt a in ed within the brackets.



# o 

# I**~\X** 

# 2els

- oaw

# ~- - - --- Ph.D ., Di r ector Che mica l Co n trol Divi sio n Office of Pollution Pr evention and Toxics

### A TT**ME~ T**  

### A D

EF I N IT IONS 

### f

Note: The attached Order may not contain some oft he terms dejined below.} "Chemical name" means the sc ienti fie designation of a chemica l substance i n accordance with the nomenclature system developed by the Chemical Abstracts Serv i ce's ru les of nomenclature, or a name which wi ll clearly ident i fy a chemical substance for the purpose or conducting a hazard evaluation.



# . "C hemical protective clothing" mean s items of cloth i ng that provide a protective barrier to prevent dermal contact wi t h chemical substances of concern . Examples can include, but are nol limited to: full body protective clothing, boots, coveralls, gloves, jackets, and p a nts.**"Company'~** means the person or persons subject to this Order
. . "Co mmercial use" mean s the use of a chemical substance or any mixture containing the chemical s ubstance in a commercial ente rpri se providing saleable goods or a se rv ice to consumers (e.g., a commercial dry cleaning estab lishment or painting contractqr). "Common na me" means any desi g nation or idcnti ficatio n such as code name, code number, trade name, brand name, or generic chem ic a l name used to identif y a chemical substance o thtr than by its chemical name. "Consumer" means a pri vate indiv idua l who uses a chemical substance or any product containing the chemical substance in or around a permanent or temporary household or re s idence , during recreat ion, or for any personal use or e njoym e nt. "Consu m e r product" means a chemica l substance that is direc tl y, or as pcllt of a mixture , sold o r made availab!C to cons umers for their u se in or aro und a permanent o r temporary household or residence. in or around a school. or in recreation. '·Co ntaine r '' means any bag, barrel , bottle , box, can, cyl i nder, drum, r eacti o n vessel , storage t a nk , or the like that co n tains a hazar dous chemical. f-or purpo ses of this sect ion, p ipes or piping syste m s, and e n g in es, fuel tanks, or other operating syste m s in a veh i cle, are not considered to be con tainers. "Contract Manufacturer" means a person, outside t he Company, who i s authorized to manufacture (which includes import) the PMN subs tance under the co nditions speci fied in Part II. of this Consent Order and in the Consent Order for Co ntract Manufa c turer. "Identi ty" means any chemica l or common name used t o identify a chemica l s u bstance or a mixture containing that s ub s tance.2

" Im mediate use." A**~;hemical** substance is for the " imm ediate use" of a person if it is under the co ntrol of. a nd u sed o nl y by, the p e rso n who transferred it from a labeled con tainer a nd will o nly be u sed by that perso n within the wo rk s hift in wh ich it i s transferred fr o m th e labeled con ta in er.

" Imp erv ious . " Chemical protec tive cl othi ng is "i mp ervi ous'' to a c h emical s ubstan ce if the s ub s t ance causes no chemica l or me c h a nica l degr adati on, perm ea ti on, or pen et r ation of th e chei1l i ca l protective clothing under the cond iti ons of, an d the duration of, exposure .

" Manu fac ture " m eans to produce or manufacture in th e Un it ed S tates o r impo11 into the c u st o ms t e ni to r y of the Uni ted Stute s . "Manuf ac turin g strea m " means all r easo nabl y ant icipated transfer , flow, or dispo sa l of a chem ical s ub s tan ce, regardle ss of phy s ical state or co n ce ntr ation , through a ll int en ded operati o n s o f manufac t ur e, in clud i ng th e cl e aning of equipment.

. . "MSDS" mea ns material safety data s h ee t. the writ ten li s tin g of data for th e chemical subs tance. "N lO SH" m eans the National In s tit ute lor Occ upation a l Sa f ety and Il ea lth of th e U
. S
. D epa rtment o f I f ca lth and Human Services. "No n- enc losed pr ocess" means any equ ipm ent syste m (suc h as an open-top reacto r , storage tank, or mixin g vesse l) in wh ic h a chemical s ub s ta nce i s manun\ctured , processed, o r otherwise u sed where s ig nifi cant dir ect co nt act o f**th~;;** bulk c hemi ca l s ub stance and the wo r kplace ai r may occur. "No n-indu s u· ial usc:' means use o th e r than at a fac il ity where che mi cal substances or mixture s are manufactured o r processed
.
« PMN s ub stan ce" means the c h emica l subs ta n ce des cribed in the Prcm anu fac turc noti ce sub mitt ed by th e Co mp a ny r elevant to thi s Orde r.

" Perso na l prote c ti ve equ ipment" me a ns any c hem ic a l protective clothing or devic e pl aced o n th e body to p r eve nt co nt ac t w ith , and exposure to, an identified c hemic a l subs t ance or substances in the wo rk area . Examp les in clude, but a r c not limited to, che mi ca l p ro tecti ve clothing, ap rons, hoo ds , chem ical gogg les, fac e s pla s h s hield s, or equivalent eye pro tection , and vari ous types of respirato rs. Barrier creams a re no t included in thi s definition
. "Process stre am" m eans a ll r easonably an t i cipated tran sfer, flow, o r disposal of a chemical substance, regardle ss of phys ic a l state o r concen tr atio n , through a ll intended o p erat i ons of pro cess in g, inc luding the c le a nin g of equ ipm en t. "Sc icnti l i cally i nva li d" means any s i gnificant departure from th e EPA-reviewed protocol or the Good Laboratory Pr act ice Standards at 40 CFR Pan 792 w it hout prior o r subse qu ent Agt::ncyJ review that prevents a reasoned eva lu ation of the h ealth or env ir onmenta l effects of the Pl\llN subs tance. "Sc i e ntifi ca ll y equ i voca l d ata" means data which, a ltho ug h d eve lo p ed in apparent co nformity w i th the Good Laboratory Pra c ti ce Standa rd s and E PA-r ev i ewed protoco l s, are inconclusive , internally in consis tent, o r o th e r wi:;c insufficient to permit a reasone d evaluation of the potential risk of injury t o human health or the env ir onment of the PMN s ubstance.

" Sealed container" means a closed container th a t is physica ll y and c h en1ically su it able for l ong-term con t ainment of t he PMN s u bstance , and from which the re w 111 be n o human exposu r e to , nor environ m enta l release of, the PMN substa n ce du rin g transport a nd s torage. "Use stream" m eans all reasonably an ti c ipated transfe r , 1lo w, o r disposa l of a chemical subs tance, regardless of phys ical state o r conce ntra tion, through al l .i nt e nd c d ope ra ti ons of industrial. com m ercial. or consumer u se . "Waters or the United States'' ha s the meaning set forth in 40 CF R 122.2. "Wo rk area" means a roo m or defined s pace in a workplace where th e PMN substamx: i s manufactured, processe d , o r used an d where e mpl oyees arc present. "Wo rkpla ce'' mea n s an estab li s lun ent at one geographic loca t ion conta in i n g o n e or more work areas.Company (Transferor) ATTACHMENT B NOT I CE OF TRANSFE R OF T O X I C SUBSTANCES C O NT RO L ACT SECTION S(c)**CO~SENT** O RD ER

P

MN Number
I
. Transfe r of Manufac t ure Ri ghts
. Effective on , th e Company did se ll o r otherwi se tran sf er to , ("S uccessor in Int erest") th e rights and li abi liti es assoc iated w ith manuf ac tur e o f the above -refe r enced c h em ical substan ce, which was rhc s ubject of a prcmanufacturc notice (" P lv

f N" ) and is gove rn ed by a Consent Order issued by the U.S. Environmenta l Protecti on Agency ("EPA") under the au th o.rity of §5(<::) of th t! Toxic
. Substances Contro l Act ("TSCA." 15 U.S.C. §260 4 (e))
. 2
. Assumption ofLin hilit y. T he Successo r in In teres t her eby ce rtifi es that, as o f th e effective da te of transfe r, a ll ac tion s o r o mi ssio n s governed by th e applicab le Con se nt Order limitin g manufacture. processing. u se, di stributi on in commerce and di sposal of the 

### PN 1 N s ub s t ance. s hall be the r espo ns i b ili ty of th e Successor in Int e r est. Successor in Int eres t also cer tifi es that it is incorpora ted , licensed, or do in g bus in ess in t he United States in acco r dance wit h 40 CFR 720
. 22(a)(3).
3. Confi d ent ial Du s in css Information. The Successor i n Intere st**h~rcby:** reasserts

- 

### ,

_ relinquishe s, o r modifies all Con fidential B usiness Information ("CB l' ') claims made by th e Company, pursuant to Section 14 ofTSCA and 40 CFR part 2, for th e PMN s ub s tance( s)
. Where " r easse rt s" o r ''re lin quishes" i s indicated. that designation shal l be deemed t o app ly to all suc h claims. Wh ere "mod ifi es" is indicated , s uc h modifi cat ion shall be ex pl ained in detail in a n a tt ac hm e nt to thi s No tice of Transfer. Inf ormat i o n w hi c h h as been previous ly di sc losed to the public (e.g., a c h e mi cal identity th at was no t claimed as CB I by the ori ginal s ubmitter) wo u ld not subsequently be elig ib le for confide ntial treatment unde r thi s Notice of Tr a nsfer.N OTI CE O F T RANSFE R O F T OXI C SU B S T ANCES C O NT RO L A C T SEC TIO N S (e) C O NSE NT ORD E R (continu e d )
C omp a n y (T r a n sfe r o r ) PMN Number
Signa ture of Authorized Officia l Dat e Printed Name o f Authorized Officia l
Title of Authorized Official

S u ccesso r in Int e r es t

S i gna tur e of Authorized Offic i al D a te
Prin t ed Name of Authorized Officia l
Tit le of Authorized Official
Ad dre ss 

### City , S ta le . Zip CodeNOTICE O F TRANSFER OF TOXIC SUBSTANCES C ONTROL ACT SECT I ON S( c) CONSENT ORDER (cont inu ed)

Successor's Technical Co nt ac t
A ddre ss
C it y, S t a t e, Zip Code
Ph o neATTACHMENT C STA TISTICAL ANALYSIS OF NCELs ANALYTI C AL METHOD VERIFICAT I ON RESULTS Th i s Attaclunent describes the sta t istical t cc lm ique (w ith exam ple s) for comparing th e analytica l results obtained by two l aboratories pur s u ant to paragraph (c ) (3)(v i i) of th e New Chemical Exposure Limit section of this Order. STATISTICAL TECHN IQ UE To obtain two-sample t test with unequal variances, perform the followi n g operations:

. . . • Compute m eans of the data m easured by tw o l ab orato ries.
• Compute mean squares

• Form U 1e ratio

• Compute degrees o f freedo m

vvhcrc ,

- Xt =Ave rage of the res ult s from th e company laboratory



### - 

### X2 =A vcrage of the results fro m the ind ependent l aborato ry
n 1 =Nu mber of samp les analyzed by t he company laboratory n2 =Nu mber of samp les analyzed by ·the ind epe ndent laboratory.IV

Th en co mp are the absol ut e va lu e ofT t o the 97.5 pe rcentil e poi nt of a t di s tribut ion w ith f d egrees of freedom . I f the absolute value exceeds the 97
. 5 pe rcenti le point, th e res ult s measured by two lab o ratorie s are s i g nifi cantl y d i fferent at 95% l evel. Otherwise, they a re n ot sig nifi can tl y d iffe rent. In ge n e ral , fmay n ot be a n int ege r. Use i nte rp o lat io n to ob t ain th e 97.5 percentile po int of at d i s tribution with f degrees**off e~** **orn .** 


### EXA MPL ES

-- The following exa mple s (based on s imul ated dat a) illu strate th e method: Example 1



### - 

# x, = 83
. 30 Data Set 1 80.56 100.01

86.04 52
. 61 84.85 95
. 75

Absolute va lu e ofT= 2.467 

### - 

## x2 = 1 

## oo.4o s} ;:;: 9.26 f=5.33 D a t a Set 2

97. 1 1 10 2 .1 3

99 .8 3 97.83 105.44 1 00
. 04

The t table s hows that the 97.5 pe rce ntil e po int is 2
. 57 1 and 2
. 447 for 5 and 6 degree s of freedo m , re s p ec tive ly . For 5.33 degree s o f freedom, the 97.5 percenti l e point will b e app rox imately 2.530 whi ch i s g reate r than th e abso lu te value ofT, 2.467. Hence , the means of two data se ts are not sig nificantly di fferent at t h e 5% leve l. Howeve r, if th is problem had been trea t ed as an o rd inary two
- samp l e t test, th e means wou ld be sig ni fican tly different at the 5% l evel because the absol ut e ofT i s grea te r th a n 2.228, the 97
. 5 percenti l e point for th e t d istr ibuti o n wit h 10 deg rees of freedom. Examp le 

### 2 Data Se t I 82.87 1 01.85

87.44 99.68 I 01.15

99.2 1 

### _ Data Set.2 108.0 5

96
. 5 1 100.04 104.33 110 .32 107.00v



### - 

### - X 1 

### = 95.37 n 1 

### = 6 

# x2 = 104.37 

# s,' = 65.59 

## w, = 10.93 S/ 

## = 27
. 25 

## w2 = 4.54 Absolute value ofT= 2.290 

### f = 8
. 5
.4 The t table s h ows that for 8 and 9 degrees of freedom the 97
. 5 percentile point is 2
. 306 and 2.262, respectively. For 8
. 54 degrees of freedom the 97.5 percentile point will be approximately 2.282 which is les s than the absolute value ofT, 2.290. Hence, the means of two data sets a re s ignificantly d i fferent at the 5% level.**J~OOA::>lT ~OITAMJK>l~**  l23Yfi2U8 JA"101TAK**~nf03** T0"1 2300
1**;> rlO~**  I 0 3) iO'fAMJIOM**YltJI~**

# Fate Report PMN No
. L-15-025 4 Report Status : Completed Status Date : 04/23/20 1 5 04:3 1 :28 PM Fate Assessor : Fate Summa ry Sta tement: L-15-0254 FATE: Solid wi th MP = Dec. 133 •c ( M ) 

### s > 1

### o giL at 25 

### · c (E) VP < 1 .0 E -6 torr a t 25 •c (E) H < 1.00E-8 (E) POTW removal (%) = U; OECD 301B(C i osed Btl ): 20 %( avg)/28d. Time for complete ultimate aerob ic biodeg = U Sorption to soils/ sediments = U PST Potential : P281 'CEB FATE: Migration to ground water= U Physical Pro pe rties: Property Measured I Calculated Value Molecular Form: C18 H40 Mn2 N6 02. C2 H4 0 2
. 2CI Molecular WI: 612.39 % < 5 00 % < 1 000



### - - EPI

N/A I N/A

" Property Measured Value Method Estimated Value Method Melting Point: Dec. ca. 133 MSDS Boiling Po int: B P Pressure: N/A 1@760 N/A 

# . Vapor <0 .0000 01 Sal t Pressu re: Water >385 Fo rmu l ation Solubility: Log P : Log Kow : N /A N/A Log Koc: N/A N /A N/A Log BCF : N/A N /A N/A N/A BCF : N/A N/A N/A N/A H enry's Law: N /A N/A N/A N /A



# - -**t~:Comment :**  ££& &£% &L E£ 2 f

Fate Ana l ysis: Hydrolysis ( 11 /2,**~olatiliza ion**  Vola t i l ization**~a):** t1 /2 ) -River t1 /2) -Lake ( da } hr): jAtm Ox Pot entia l**m** Ox Potential f"tmOx EPI
1@760

N/A

i'

" '

_ ,

J¥i£ f,£ £±£ £& 

# "'(t 1/2)0 H (h r}: (J1 / 2 ) 03 ( h r: Potential(t 1 /2) jro tal (hr): MIT I Li near: MIT! Nonlinear: Bio deg Li ne ar: Biodeg Non li near: Biodeg Survey ult: Biodeg Survey Pri m : STP (% rem ova l } ST P (% removal) tTo ta l: Biodeg: STP (% removal} !Acts: STP (% removal) lAir :**~** PST Ra t in s : Persistence Bioaccumulation Tox i city PST Comments ( 1) 2 (1) 1 (1) Await i ng H uman ( 1 ) Hea l th Entry ( 2) ( 2) (2) Awaiting H uman (2) Hea l th En t ry 3) 3) 3) Awaiting Hu man**~ealth** Entry
. 3) 4) 4 ) 4) Await i ng Human H ea lth En try 4) 5) 5) 5) Awa i ting Human 5)


# .**~ea th**  En try
E x posure-Based Testing: Fate Ratin s:

Removal in WWT/POTW (Overall): u Rating Description Condition Rating Values 1 2 3 4 Comment WWT/POTW Sorption: 1 Low Mode rate Strong V. Strong WWT/POTW Stri pp i ng 4 Ex tensive Moderate Low Neg l i g i ble Biodegradation Removal: 4 U n k nown H igh Moderate Negli g i ble Bio de gra dation Destruct i on: Unk nown Co mpl ete Partial 

### - Ae robi c Biodeg U lt : u <=Days Weeks Months >Months Aerob i c Biodeg Prim : <=Days Weeks Months >Months Anaerobic B iodeg U l t : u <=Days Weeks Months >Months Anaerobic Biodeg P rim: <=Days Weeks Mont hs >Months Hydrolysis ( t1/2 at p H 7,25C) A: <= Minutes Hou rs Days >=Months H y d rolys i s (t1/2 at p H 7 , 25C) 8: <=M i nutes Hou rs Da ys >=Months Sorption to Soils/Sediments: u V. Strong Strong· Mode rat e Low M i gration to Ground Water: u Neg ligible Slow Mode r ate Rap i d Photol ysi s A. D i rect: Ne gl i gible Slow M oderate Rap i d Photol ysis 8, i n direct: N egl ig i ble Slow Moderate Rap i d Atmosphe r ic Ox A, OH: Negligible S low Mod erate Rap i d Atmospheric Ox B, 03: Negligible Slow M oderate Rapid Bio Comments : OECD 301B(Ciosed B tl }: 20%(avg)/28d. Fate Comments:

Attachments:

Initial Review Reports**~~ ~'** **~ ~**  Chemistry Report Created by Thomas Webb on 04 / 23/ 2015 Fate Report Created by Thomas Webb on 04/23/ 2015 Ecotox Report Created by Kendra Moran on 04/23/20 1 5 Human Health Rpt Created by Kendra Moran on 04/24/20 1 5 SAT Report Created by Kendra Moran on 04/24/2015 Engineering Report Created by Rehan Choudhary on 05/ 01 / 2015 Engineering Report Created by Sharon Austin on 05/ 29/ 2015 Exposure Report Created by Elizabeth Nguyen on 05/ 01 / 2015

Last Updated by Thomas Webb on 04/23/2015 at 03:31:48 PM

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t Created by Thomas Webb on 04/23/20 1 5