Contains Confidential Business Information (CBI) 

Date: June I sa, 2015 

Jeff Bauer 

Program Manager 

United States Environmental Protection Agency 

Washington D. C. 20460 

Re: PMtLP-15-328 

Dear Mr. Bauer, 

and 1 am the 

acknowledge the receipt of the enclosed Consent Order, and have 

signed the document where appropriate on behalf of the company. - has retained th'e 

additional copy of the Consent Order at our New York office for fu rstanding, and 

compliance. 

Jfthe EPA has any questions or concerns, please feel free to contact us. We understand the Consent 

Order is effective when received by EPA. We look forward to the EPA's confirmation of the document's 

receipt. 

Thank you very much for your consideration. 

Sincerely, 
UNITED ST A 'fES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

Tn the matter of: ) Premanufacture Notice Number: 

) 

) 

) 

) 

) 

) P-1 5-328 

) 

) 

) 

) 

) 

Consent Order and Determinations Supporting Consent Order 
.. 

ll 

TABLE Of CONTE~TS 

Preamble 

l. Introduction 

Jl. Summary ofTenns of the Order 

II I. Contents of PMN 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Jnfo.rmation Required to Evall}.ate Human I Iealth and t:~ ironm ental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

II. Terms of Manufacture, Processing, Distribution in Commerce. Use. and Disposal 

Pending Submission and Evaluation of Information 

TIL Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment 1\ - Definitions 

Attachment B - ~otice of Transfer of Consent Order 
Ill 

PREAMBLE 

I. INTRODUCT ION 

Under the authority of§ S(e) of the Toxic Substances Control Act ("TSCA'') (J 5 U.S.C. 

2604( c)), the Environmental Protection Agency ("EPA" or "the Agency") issues the attached 

Order, regarding prcmanufacturc notice (''PMN") P-15-328 for the chemical substance 

[ ("the PMN substance'') submitted by 

("the Company"), to take effect upon expiration of the PMN review period. The Company 

submitted the PMN to EPA pursuant to§ S(a)(l) ofTSCA and 40 CFR Part 720. 

Under§ 15 ofTSCA, it is unlawful for any person to fa il or refuse to comply with any 

provision of§ 5 or any order issued under§ 5. Violators may be subject to various penalties and 

to both criminal and civil liability pursuantto § 16. and to specific enforcement and seizure 

pursuant to§ 17. ln addition, chemical substances suhject to an Order issued under § 5 of 

TSCA, such as this one, are subject to the§ 12(b) export notice requirement. 

TJ. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for this PMN substance requires lhe Company to: 

(a) provide respirators to its workers to prevent inhalation exposure; 

(b) as an alternative to using respirators, maintain workplace airborne concentrations of the 

PJ\IIN substance at or below a specified ~ew Chemical Exposure Limit ("NCEL") of 5 mg/m3

, 

verified by actual exposure monitoring data (to pursue this option, a sampling and analytical 

method must be developed by the Company. verified by an independent third-party laboratory, 

and submitt~d to EPA); 

(c) Not use the PMN $Ubstance other than as an and 
IV 

(c) maintain certain records. 

III. CONTENTS OF PMN 

I3y signing this Order, the Company represents that it has carefully reviewed this document and 

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

identi lied within brackets and that any informat ion that is not bracketed is not claimed as 

confidential. To make this document available for public viewing. EPA will remove only the 

information contained within the brackets. 

Confidential Business Information Claims (Bracketed in the Preamhlc and Order): Submitter 

identity, chemical name, production volume, specific usc, worker a11d environmental exposures. 

Chemical Identity: 

Spccifi~: 

Gl:ncric: Aluminum calcium oxide salt 

Us.c: 

Specific: 

Generic: Cement additive 

Maximum 12-Month Production Volume: 

Test Data Submitted with PMN: None 

IV. EPA'S ASSESSMENT OF EXPOSURE AND n JSK 

The following arc EPA's predictions regarding the probable human toxicity and human 

exposure of the· PMN substance, based on the information cunently available to the Agency. 

Human Health Effects Summary: 

Absorption: Absorption is nil all routes based on physical/chemical properties. There is concern 

for lung toxicity based on lung overload from poorly soluble respirable particulates. 
v 

Toxicological Endpoints of Concern: There is concern for lung toxicity based on lung overload 

from poorl y sol ubh.: respirable particulates. 

Basis: Poorly soluble respirable particulates 

See wv.w.epa.gov/opplintr/newchems/pubs/chemcat.htm 

Exposure and Environmental Release Summary: 

#Sites 

Workers 

Exposure. 

(days/year) 

Inhalation Exposure 

(mg/day) 

Process 

I 

I 

I 

L_ 

Use 

I 

I 

I 

Risk to Workers: Concern for lung toxicity if inhaled based on lung overload for poorly soluble 

parti cul ates ( 40% < l 0 um). 

V. EPA'S CONCLUSIONS OF LAW 

The following findings constitute the basis of the Consent Order: 

(a) EPA is unable to determine the potential for human health effects from exposure of humans 

to the PMN substance. EPA therefore concludes, pursuant to § S(e)(J )(A)(i) ofTSCA, that the 

information avai lable to the Agency is insufficient to permit a reasoned evaluation of the human 

health effects of the PMN substance. 
VI 

(b) In light of the potential risk ofhuman health posed by the uncontrolled manufacture (which 

includes impo11), processing, distribution in commerce. use. and disposal of the PMN substance. 

EPA has concluded, pursuant to § 5(e)( I )(A)(i i)(l) ofTSCJ\, that ur~comrolled mnnufactur?, · 

processing. distribution in commerce, use, and disposal ofthc PMN substance may present an 

unreasonable risk of injury to human health. 

. Yl. INFORVIATJON REQUIRED TO EVALlJATE HUMAN HRAL TH AND 

ENVIRONM ~N L EFFECTS 

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

following effects which may he caused by the P:vrN substance: 

Information Effects Guidelines · 

A 90-day inhalation toxicity test Fibrogenicity OCSPP 870.3465 

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

production volume. However. the Order's restrictions on m~nufacture , processing, and usc of 

the P:vr.\ substance will remain in effect until the Order is modified or revoked by EPA based on 

submission of that or other relevant information. 
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

WASH NGTON, D.C. 20460 

CONSENT ORDER 

I. SCOPb: OF APPLICABILITY AND EX ONS 

(a) Scope. The requirements of this Order apply to all commercial manufacturing, processing, 

distribution in commerce, use and disposal of the chemical substance 

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

Company"), except to the extent that those activities are exempted by paragraph (b). 

(b) Exemptions. Manufacturing, processing, distribution in commerce, usc and disposal of the 

PMN substance is exempt from the requirements of Lhis Order (except the requirements in the 

Rccordkceping and Successor Liability Upon Transfer Of Consent Order sections) only to the 

extent that (1) these activities are conducted in full compliance with all applicable requirements of 

the following exemptions, and (2) such compliance is documented by appropriate recordkeeping as 

required in the Rccord.keeping section of this Order. 

Internet Addross (UHL) • http //www epa.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 
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( 1) Export. Until the Company begins commercial manufacture of the PM)-1 substance for 

usc in the United Statt!S, the requirements of this Order do not apply to manufacture, processing or 

distribution in commerce of the PMN substance solely for export in accordance with TSCA 

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

manufacture the PtvrN substance for usc in the United States. no ftwthcr activity by the Company 

involving the PMN substance is exempt as "solely lor export'" even if some amount of the PMN 

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

associated with the PMN substance while in the territory of the United States. Prior to leaving . .. . . 

U.S. territory, even tho~e quantities or batches of the PMN substance that are destined for export 

are subject to terms of the Order, and count towards any production volume test triggers in the 

Testing section of this Order. 

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

manufacturing, processing. distribution in commerce. use and disposal of the P\tfN substance in 

small quantities solely for research and development in accord~u1ce-wi th TSCA §5(h)(3), 40 CfR 

720.J(cc), and 40 CFR 720.36. The requirements of this Order also do not apply to manufac turing, 

processing, distribution in commerce, usc and d isposal of the Pt-.1N substance when manufactured 

solely for non-commercial research and development per TSCA §5(i) and 40 CFR 720.30(i) . . 

(3) Byproducts. The requirements of this Order do not apply to the PMN substance "Yhen 

it is produced, without separate commercial intem, only as a '·byproduct" as defined at 40 CfR 

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

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

PMN substance when it is manufactured. pursuant to any of the exemptions in 40 CFR 720.30(11), 

with no commercial purpose separate from the substance, mixture, or article of which it is a part. 
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(5) Imported Articles. The requirements of this Order do not apply to the PMN substance 

when it is imported as part of an "article" as defined at 40 CFR 720.3(c) and in compliance wilh 40 

CFR 720.22(b)(1 ). 

(6) Completely Reacted (Cured). The requirements of this Order do not apply to quanti tic ~ 

of the PMN substance after they have been completely reacted (cured). 

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

Exemption ("TME") under TSCA §S(h)(l) and 40 CFR 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 exemption is automatically rendered null and void as 

of the effective date of this Consent Order. 

II. TERMS OF MANUFACTURE, PROCESSING, 

DlSTRIRUTJON IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVAL UATION 

OF INFORMATION 

PROHIBITION 

The Company is prohibited from manufacturing (which under TSCA includes importing), 

processing, distributing in commerce, using, or disposing of the PMN substance in the United 

States, for any nonexempt commercial purpose, pending the development of information necessary 

for a reasoned evaluation of the human health effects of the substru1cc, and the completion of 

EPA's review of, and regulatory action based on, that information, except in accordance with the 

conditions described in this Order. 
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TESTING 

(a) Section 8(e) Reporting. Reports ofinfonnation on the PMN sul;>stance which reasonably · 

supports the conclusion that the PMN substance presents a substantial risk of injury to health or the 

environment and which is required to be reported under TSCI\ section 8(e) shall efe enc~ th~ 

appropriate PMN identification number for this substance and contain n statement that the 

substance is subject to this Consent Order. Additional information regarding section 8(e) rcpor1ing 

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

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

Assistance and Media Programs Division, Office of Enforcement and Compliance Assurance, U.S. 

Environmental Protection Agency, of the following information wil)1in I 0 days of scheduling·any 

study required to be performed pursuant to this Order. or within 15 days after the effective date of 

this Order. whichever is later: 

(I) The date when the study is scheduled to commence; 

(2) The name and address of lhe laboratory which wil l conduct the study; 

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

EP 1\ may contact regarding the study; and, 

(4) The appropriate P1vfN identification number for each substance and a statement that the 

substance is subject to this Consent Order. 

The wrincn notice should be submitted to EPA as follows: 

Postal Mail Address 

U.S. Environmental Protection Agency 

GLP Section Chief- Ptsticides, Water and Toxics Branch 
- 4-

Monitoring Assistance and Media Programs Division (2227 A) 

Office of Enforcement and Compliance Assurance 

1200 Pennsylvania Avenue, N.W. 

Washington, DC 20460 

Courier Delivery Address 

U.S. Environmental Protection Agency 

GLP Section Chief- P·csticides, Water and Toxics Branch 

Monitoring Assistance and Media Programs Division (2227 A) 

Office of Enforcement and Compliance Assurance 

Room 71178 

I 200 Pennsylvania A venue, N. W. 

Washington. DC 20004 

(c) Good Laboratory Practice Standards and T~st Protocols. Each study performed to address the 

risks identified in this Order must be conducted according to TSCA Good Laboratory Practice 

Standards at 40 CFR Part 792 and using methodologies generally accepted in the relevant 

scientific community at the time the study is initi ated. Before starting to conduct any study that 

v.rill usc a modified version of a published test guideline, the Company must submit \Witten test 

protocols to EPA for review (submission of written test protocols is optional for tests that arl! to be 

conducted using unmodified published test guidelines). Protocols must be submitted as a support 

document for the PMN, using the procedures set out in 40 CFR 720.40. EPA will respond to the 
- 5 -

Company within 4 weeks of receiving the written protocols. EPA review of a test protocol does 

not mean pre-acceptance of test results. 

(d) Unreasonable Risk. 

EPA may notify the Company in writing that EPA finds that the data generated by a study 

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

substance will or may present an unreasonable risk of injury to human health or the environment. 

EPA's notice may specify that the Company undertake certain actions concerning further testing, . . . 

manufacture, processing, distribution, usc and/or disposal of the PMN substance to mitigate 

exposures to or to better characterize the risks presented by the PMN substance. Within 2 weeks 

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

use and d isposal of the PMN substance, unless either: 

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

such requirements as the notice specifics; or 

(2) within 4 weeks from receipt of the EPA notice, the Company submits to EPA a 

written report refuting EPA's linding and/or the appropriateness of any additional requirements 

imposed hy F.PA. The Company may continue to manufacture, process, distribute, use and dispose . 

of the PM~ substance in accordance with the tem1s of this Order pcndi ng EPA· s response to the 

Company's written report. EPA will respond to the Company, in writing, within 4 weeks o f 

receiving the Company's report. Within 2 weeks of receipt of EPA's written response. the 

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

manufacture, processing, distribution, usc and disposal of the PMN. substance. 
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PROTECTION IN T HE \VORKPLACE 

(a) hStablishment of Program. During man ufacturing. processing, and usc of the PMN substance 

at any site controlled by the Company (including any associated packaging and storage and during 

any cleaning or maintenance of equipment associated with the PMN substance), the Company 

must establish a program whereby: 

(I) Respiratory Protection. Each person who is reasonably likely to be exposed by 

inhalation in the work area to the PYJN substance in the form listed in subparagraph (a)(2) of this 

section is provided with and is required to wear, at a minimum, a Nationallnstitute for . . . 

Occupational Safety and HenlU1 ("NIOSH")-ccrtiiied respirator with an Applied Protection Factor 

(''APfo''') of I 0, from the respirators listed in subparagraph (a)(3) of this section, and the respirator 

is used in accordance with OSllA and NIOSH respiratory protection requirements at 29 CFR 

191 0.134 and 42 CFR Patt 84. All respirators must be issued. ust:d. and maintained according to 

nn appropriate respiratory prot'eetion program under the OSHA requirements in 29 Cfo'R 1910.134. 

(2) Physical States. The following physical states of airborne chemical substances are 

listed for subparagraph (a)(l) of this section: 

(i) Particulate (including solids or liquid droplets), 

(ii) Gas/vapor (all substances in the gas fonn), or 

(iii) Combination GasNapor and Particulate (gas and liquid/solid physical stales 

arc present; a good example is paint spray mist, whi ch contains both liquid droplets and vapor). 

(3) Aulhorizt:d Respirators. The following NJOSH-certiftcd respirators meet the minimum 

requirements for subparagraph (a)( I) of this section: 
Assigned 

Pt'otcction 

- 7-

Type of Respirator 

(I) Any NIOSH-cer1i fied air-purifying clastomeric half-mask respirator 

equipped with NlOO (if oil aerosols absent), RlOO, or Pl OO filters. 

(II) Any appropriate 1 IOSH-ccrtified N I 00 (if oil aerosols absent), R 100, or 

P 100 filtering facepiecc respirator. [Note: for filtc1ing facepieccs, an APf' of 

I 0 can only be <tchievcd if the respirator is qualitatively or quantitatively fit 

tested on individual workers. 

(Ill) Any NIOSH-certified air-purifying full facepiecc respirator equipped 

with N I 00 (if oil aerosols absent). Rl 00, or PI 00 filters. 

(IV) Any NIOSH-certiiied negative pn;ssure (demand) supplied-air 

respirator equipped with a half-mask .. 

(V) Any NIOSH-certified negative pressure (demand) self-contained 

.__ ____ _,_b_r_e_a_th_i_n-">---'- aeparatus (SCBA) equipped with a ha.c.: lf'--' · ;..__:_: _;·· ___ ____ ___~ 

(b) De Minimis Concentrations. The requirements of this section do not apply to quantities of the 

PMN substance that arc (1) present in the work area on ly as a mixture and (2) at a concentration 

not to exceed 1.0 percent by weight or volume (0.1 percent by weight or vol ume if the PMN 

substance is identified as a potential carcinogen in paragraph (f) of the Hazard Communication 

Program section of this Order). This exemption is not avail ahle if the Company has reason to 

believe that, during intended activities, the PtvfN substance in the mixture may be reconcentrated 

above the l.O or 0.1 percent level. whichever applies. If this Order contai ns )Jew Chemical 

Exposure Limits provisions or Release to Water provisions that, respectively, specify a NCEL 

concentration ("TWA'') or in-stream concentration ("N") less than the de minimis concentration 

specified here, then this de minimis exemption does not apply to those provisions. 
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NEW CHEMJCAL EXPOSURll:: LTMTT 

(a) Alternative to Requirements of Respirator Section. 

(I) EPA recommends and encourages the use of pollution prevention, source reduction, 

engineering controls and work practices, rather than respirators, as a means of controlling 

inhalation exposures whenever practicable. 

(2) Whenever a person is reasonably like ly to be exposed to the Pl\1N substance by 

inhalation, as an alternative to compliance \Vith the respirator requirements in the Protection in the 

Workplace section of this Order, the Company may comply wi ~ the requirements of this New . . ... ... 

Chemical Exposure Limit section. Hmvever, before the Company may deviate from the respirator 

requirements in the Protection in the Workplace section of this Order, the Company must: 

(i) submit to EPA a copy of the Company's sampling and analytical method for the 

Ptv1N substance, verified in accordance with subsection (c)(3) of this New Chemical Exposure 

Limit section; 

(ii) obtain exposure monitoring results in accordance with this )Jew Chemical 

Exposure Limit section; and. 

(iii) based on those exposure monitoring results, select, provide. and ensure usc if 

necessary of the appropriate respiratory protection specified in para&.rraph (e)(2) of this New 

Chemica] Exposure Limit section by persons who arc reasonably likely to be exposed to the PM)J 

substance by inhalation. 

(3) After appropriate respiratory protection has been selected at a workplace based on the 

results of actual exposure monitoring conducted in accordance v.rith this Ne\v Chemical Exposure 

Limit section, the Company shall not, at that workplace, usc the respiratory 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 limit ("1\CEL") for the P~11\ 

substance is an interim level determined by EPA based on the limited information available 10 the 

Agency at the time of development of this Order. The NCEL for the PMN substance is as follows: 

(i) Time-Weighted 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/m3 (the 

NCEL) as an 8-hour time-weighted average, without using a respirator in accordance with 

subsection (e) of this New Chemical Exposure Limit section. 

(ii) Non-8-Hour Work-shifts. For non-8-hour work-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 number of hours in the actual work-shift. 

(2) Automatic Sunset. If, subsequent to the effective date of this Order, OS! IA 

promulgates, pursuant to §6 of the Occupational Safety and Health Act, 29 C.S.C. 655, a fina·l 

chemical-specific permissible exposure limit ("PEL") specifically appli cable to this PMN 

substance and the OSI JA PEL is not challenged in court within 60 days of its promulgation, then 

any respirator requirements in the Protection in the Workplace section of this Order and any 

requirements of this New Chemical Exposure Limit section applicable to workers and situations 

subject to the OSHA PEL shall automatically become null and void. However, the requirements of 

this Consent Order are not negated by any pre-existing OSHA PEL applicable to the PMN 

substance. 
- 10-

(c) Performance-Criteria for. ampling and Analytical Method. 

(I) Applicability. For initial development and validation of the sampling and analytical 

method for the PMN substance, all the requirements of this subsection (c) apply. For subsequent 

exposure monitoring conducted pursuant to subsection (d) of this New Chemical Exposure Limit 

section, only the following requirements apply: (c)(4)(i), (4)(ii), (4)(iv)(H), (4)(v)(Il), (8), and (9). 

Any deviation from thl! requirements ofthis subsection (c) must be approved in writing by EPA. 

(2) Submission of Verified Method and Certification Statement. The Company shal l 

submit to EPA a copy of a·validuted sampling and analytical method for the PMN substance which .. . . . 

satisJies the criteri a specified in this subsection (c). The method description shall expressly state 

how the method compares 'vYith each quantitative requirement specified in this subsection (c). The 

submission must include a wrillen statement, signed by authori zed officials of both the Company 

and the Laboratory, certifying the truth and accuracy of the independent laboratory verilication 

conducted pursuant to subsection (c)(3). To assist EPA in identifying the document, it shall state 

in a conspicuous, underlined subject-line at the top of the first page: "NCEL Sampling and 

Analytical Method for PivfN # J>-15-328". 

(3) Verification of Anal) tical Mcthud by lndcpc11dt:llt ThinJ-Ptuty Laboratory. 

(i) Verification. The Company shall have an independent reference laboratory 

("Laboratory") verify the validity of the analytical method for the PMN substance, in accordance 

with the other requirements in this subsection (e)(3). It is the Company's responsibility to ensure 

that the Laboratory complies with all the requirements specified in this subsection (c)(3). 

(ii) Independent Reference Laboratory. The independent reference laboratory must 

be a separate and distinct person (as defined at 40 CFR 720.3(x)) from the Company and from any 

other person who may have dtveloped the mtthod for the Company. 
- 1 1 -

(iii) Accreditation. The Laboratory must be accredited hy a formal ly recognized 

government or private laboratory accreditation program for chemical testing and/or analysis. 

(iv) Good Laboratory Practice Standards. The Laboratory verification of the 

analytical method for the PMN substance must comply with TSCA .Good Laboratory Practice 

Standards ("GLPS") at40 CFR Part 792. (Certain provisions of the TSCA GLPS applicable to 

toxicity testing in laboratory animals, such as 40 CfR 792.43 ("Test system care facilities''), 

792.45 ("Tc ·t system supply facilities'') and 792.90 ("Animal and other test system care>'). are 

clearly inapplicable to the NCEL requirements.) However, compliance with TSCI\ GLPS is not . . . . 

required under this New Chemical Exposure Limit section where tlie analytical method is verified 

by a laboratory accredited by either: (A) the American Industrial llygicnc Association ("All lA") 

Industrial Hygiene Laboratory Accreditation Program ("IH LAP"); or (I3) another comparable 

program approved in advance in writing by EPA. 

(v) Analysis of Duplicate Samples. The Company ~ha ll collect six duplicate · 

samples (a total of 12) at the TWA concentration. The samples shall be taken either from a 

control led environment (e.g., a scaled chamber or "glove box") which closely resembles the actual 

workplace conditions or, for solids and liquids with very low vapor pressure, by injecting the PtvfN 

substance onto a sample collection device. The duplicate samples shall he collected on identical 

collection media, at the same time, and under the same conditions. 'o ne set of six samples shall 

immediately be analyzed by the Company, U1e other set of six samples shall be analyzed by the 

I ,aboratory using the method developed by or for the Company. 

(vi) Sample Sto@gc Study. lf the results of the analysis of duplicate samples 

pursuant to paragraph (c)(J)(v) do not satisfy the requirements in p~ agraph (c)(3)(vii), the 

Company must perform a sample storage study as follows: 
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(1) Triglicate Samples. The Company shall collect six triplicate samples (a 

total of 18) at the TWA concentration. The samples shall be taken either from a controlled 

environment (e.g., a sealed chamber or "glove box") which closely resembles the actual workplace 

conditions or, for solids and liquids with very lov: vapor pressure, by injecting the ~ substanc(! 

onto a sample collection device. The triplicate samples shall be collected on identical collection 

. media, at the same time, and under the same conditions. One set of six samples shall immediately 

be analyzed by the Company. 

(ll) Analysis After Sample Storage. A sample storage evaluation shall be . . 

performed with tl1c two remaining sets of six samples. One set of six samples shall be analyzed by 

the Laboratory using the method developed by or for the Company, and the other shall be analyzed 

by the Company on the same day as the Laboratory analyzes its six samples. Specialized storage 

conditions for the samples including extraction conditions, time from sampling to extraction, time 

from collection or extraction (if applicable) to analysis and storage conditions must be specified in 

the method description. 

(vii) Comparison ofResults. The difference between the results ofthe two sets of 

six samples analyzed by the Laboratory and the Company as required in either paragraph (c)(J)(v) 

or (c)(J)(vi)(Jl) shall he evaluated using a two-sample t-test with unequal vari ances, and the two 

sides of the critical regions shall not exceed a 5% significance level. (Sec Attachment C -

Statistical Analysis of CELs Analytical Method Verification Results.) TI1e average of each set of 

six samples mus£ be within I 0% of the true valut:. If the averagt: of each set of six samples is not 

within l 0% of the true value, then the sample storage time between collection and analysis must be 

reduced until the average of each set of six samples is within I 0% of the tn1e value. 
- 13 -

(4) Accuracy. The sampling and analytical method must clearly .demonstrate the 

following: 

(i) General. The sampling and analytical method, and a11 exposure monitoring data 

relied on by the Company, shall be accurate to within ±25% at a 95% confidence level for 

concentrations of the PMN substance ranging from one half the ~CEL to twice the NCEL. 

(ii) NCEL Quantitation Limits. The analytical method should be capable of 

reliably quantifying the PMN substance across the full range of reasonably likely exposures. At a 

minimum, the analytical method must be capable of reliably quantifying from a lower quantitation . . . -

limit ("LQL") of one half the NCEL to an upper quantitation limit ("UQL") of at least twice the 

NCEL. If the Company obtains an exposure monitoring sample that is more than 10% above.thc 

nctunl UQL of the analytical method, the Company must comply with paragraph (c)(4)(i). 

(iii) Lower Quantitation Limit Signal-To-Noise Ratio. The analytical method shall 

be capable of quantifying the PMN to a concentration of one half the NCEL with a signal that is at 

least five times the baseline noise level. Baseline noise must be amplified to a measurable level 

when possible, even if the required amplification is beyond that usc'd in routine analysis of 

samples. (If baseline noise cannot be obtained, another reference must be selected. This mny be a 

peak considered to be noise caused by the reagent matrix.) The sampling preparation method must 

be speciliecl ru1d the detl.!ction limit for the analytical procedure must be reported as mass per 

injection for chromatographic techniques. 

(iv) Instrument Calibration. 

(I) Ini tial CalibraJ.ion. for method development and validation (but not 

subsequent exposure monitoring), the initial calibration shall at a minimum consist of five (5) 

calibration standards with a linear correlation of0.95 --these five (5) calibration standards must 
- 14 -

consist of one standard at each of the following concentrations: one ha lf 1he NCEL (0.5 x NCEL); 

between one half and one times the NCEL (>0.5 x NCCL,< I x NCEL); one times the NCEL (I x 

NCEL); between one and two times the NCEL (> I x NCEL, < 2 x NCEL), and twice the NCEL (2 

X NCEL). 

(II) Continuing Calibration. During each week of both method 

devclopmenUvalidation and subsequent exposure monitoring, the Company shall conduct both an 

initial instrument calibration and a continuing calibration. The Company shall perform at least one 

continuing calibration snmple at the NCEL concentration, and at least one additional calibration . . . 

sample per every I 0 samples analyzed. The continuing calibration sample shall fall within± 25% 

of the initial calibration value. If not, then the initial calibration must be repeated, and any samples 

associated with that outlying calibration check must be re-analyzed. 

(v) Calculated Percent Recovery. 

(I) Initial Calculation. For method development and validntion, the 

Company must calculate the pe rcent of the PM~ substance recovered by the analytical method 

from a sampk containing a known quantity of tht! PMN substance. The sample shall be taken 

either from a controlled environment (e.g., a scaled chamber' or '·glove box") which closely 

resembles the actual workplace conditions or, for solids and liquids with very low vapor pressure, 

by injecting the PMN substance onto a sample collection device. (Such a sample is referred to as n 

"matri x spike"). The calculated percent recovery for each matrix spike shall be greater than or 

equal to 75% and Jess than or equal to 125%. Spike concentrations for the PMN substance must be 

included in the sampling and unalytical method submitted to EPA. 

(ll) Subsequent Calculation. During each subsequent exposure monitoring 

episode or campaign, at least l matrix spike. prepared by injecting the PMN substance onto a 
- 15 -

sample collection device, shall be analyzed. (This matrix spike must be prepared at U1e NCEL 

concentration.) 

(vi) Sampling Device Capacitv. The capacity of the. sampling device must be 

tested and results reported to show under a known and well-defined set of conditions that the 

device is capable of collecting the new chemical in solid, liquid or vapor phase with minima l loss. 

The sampling device's capacity (air volume and collected analyte 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·ough testing. This testing must be done at a concentration twice . . . 

the NCEL and under conditions similar to those expected in the workplace. Breakthrough is 

defined to have occurred when the concentration of lhc:: P.MN substance in the effluent stream is 

cqunlto 5% of the concentration of the influent stream, or when 20% of the PMN substance is 

detected in the backup section of the sampler. 

(vii) Sampling Device Desorption Efficiency. Where applicable, the desorption 

e11ic iency must be evaluated for the air sampling device. A minimum of six air samples spiked 

with the PMN suhstance at least the NCEL concentration must be prepared. A r~cove y of at [e(lsl 

75% must be obtained for each of the six samples. 

(5) ]>recision. The estimate of the coefficient of variation of each set of six samples from 

the controlkd atmosphere test (spiked at I .0 NCEL, per paragraphs (c)(3)(v) or (vi)) must be less 

than 0. 1 05, including allowance of 0.05 for error due to sampling. 

(6) Interpretation of Accuracy and Precision Data. 

(i) lf a single matrix spike recovery is Jess than 75% recovery or greater than I 25% 

or the estimated precision is greater than 0.1 05, then the Company must rc-prepare the 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% but greater than 75%, correction 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 example, ifthc observed 

level is 30 mg/m3 and the percent recovery is 75%, usc the value 30 mg/m3/(0.75) = 40 mg/m3 

when determining whether tht! levels are below the exposure limit. 

(7) Representativeness. All sample conditions used to develop the methodology shall . . 

mimic the. actual workplace environment expected to be monitored. Conditions such a<; the 

temp~raturc, humidity, lighting. and presence of other chemicals, etc. must mimic the conditions in 

the workplace to be monitored. 

(8) Changes Affecting Validity. lithe workpl ace environment changes from the initial 

conditions described in the verified sampling and analytical method in a way reasonably likely to 

invalidate the accuracy of the method, then the Company must comply with the respirator 

requirements in the Protection in the Workplace section of this Order, unless the Company revalidates the method to confirm that the requirements for accuracy and precision in paragraphs 

(c)(4) and (5) are met. Exan1ples of possible changes include but are not limited to: introduction 

of a new chemical substance to the workplace which may interfere with the analysis of the new 

chemical; introduction of light to the workplace which may intcrf~re with a light-sensitive PMN 

substance; or introduction of water/increased humidity to the workplace which could react with the 

Plvtl'\ substance and cause difficulties in collection and analysis. 

(9) Comparability. All 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 laboratory verification and EPA 

receipt of the sampling and analytical method pursuant to this subsection (c) do not ensure that the 

method will produce valid exposure monitoring data. The Company is ultimately responsible for 

ensuring the validity of its exposure monitoring data. 

(d) Monitorin~ Potential Exposure. 

(I) General. 

(i) ;\ction Level. The "action level" is defined as an airborne concentration of the 

PMN substance, calculated as an 8-hour time-weighted average, eq~ta l to one half the NCEL TWA 

specified in subparagraph (b)(l ). For non-8-hour work shifts, the action level is equal to one half 

the ~CELn. (The NCELn is described in subparagraph (b)( I )(ii).) The Company may exceed the 

action level without penally. Tbc purpose of the action levd is solely to determine the requisite 

monitoring fi"equcncy. 

(ii) Representative Exposure Groups. Whenever exposure monitoring is required 

by this New Chemical Exposure Limit section, the Company shall take representative samples of 

what the potential exposure of each person who is reasonably likely to be exposed to airborne 

concentrations of the PMN suhstance would be if respirators were nol worn. The Company shall 

do so by sampling the breathing zone air of at least one person that represents, and docs not 

underestimate, the potential exposure of every person performing the same or substantially similar 

operations in each work shift, in each job classification, in each work area (hcreinaftt.::r idcntificd as 

an "exposure group"') where inhalation exposure to the P~1N substance is reasonably likely to 

occur. The exposure of each person need not be itself directly sampled if that exposure is 

represented by sampling the exposure of another person in the same exposure group. 
- 18 -

(iii) Good Laboratory Practi ce Standards. Determinations of potential inhala1ion 

exposure shall be made according to TSCA Good Laboratory Practice Standards at 40 CFR Part 

792 and the sampling and analytical method developed pursuant to subsection (c) of this New 

Chemical Exposure Limit section. (Certain provisions of the TSCA GLPS applicable to toxicity 

testing in laboratory animals, ch as 40 CFR 792.43 ("Test system care facilities"), 792.45 ("Test 

system supply facilities") and 792.90 ("Animal and other test system care"), are clearly 

inapplicable to Lhe NCEL requirements.) However, compliance with TSCA GLPS is not requirl!d 

where exposure monitoring samples nre analyzed by a laboratory accredited by either: (A) the . . . .. 

AIHA JJ IL/\P; or (B) another comparable program approved in advance in vvriting by EPA. 

(iY) Full Shift E~QQ_surc Samples. RepresentCl tivc 8-hour TWA airborne 

concentrations shall be determined on the basis of samples representi ng the full shift exposure for 

each exposure group. 

(2) Initial Monitoring. I3eforc the Company may deviate from the respirator requirements 

of the Protection in the Workplace section, the Company shall conduct initial exposure monitoring 

to accura tely determine the airborne concentration of the PMN substance for each exposure group 

in which persons are reasonably likely to be exposed to the PMN substance. 

(3) Periodic \!Jonitoring. 

(i) If any representative samples taken during the initial exposure monitoring reveal 

an airborne concentration at or above the action level but at or below the TWA, the Company shall 

repeat the exposure monitoring for that exposure group at least every 6 months. If the PMN 

substance is not manufactured, processed, or used at all during n given 6 month calendar period, 

the Company is not required to conduct exposure monitoring until manufacture, processing, or use 

of1hc PMN substance is resumed. However, cessation of manufacturing, processing 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 samples taken during the initial exposure monitoring 

reveal an airborne concentration above the TWA, the Company shall repeat the exposure 

monitoring for that exposure group at least every 3 months. lf 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 exposure 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 the 3 month period does not constitute grounds for postponement of the 3 

month deadline to conduct exposure monitoring. 

(iii) The Company may alter the exposure monitoring schedule from every 3 

months to every 6 months for any exposure group for whom two consecutive measurements taken 

at lt:ast 7 days apart indicate that the potential exposure has decreased to the TWA or below, but is 

at or above the action level. Where 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 the highest peak exposures and 

variabi lity in exposure. 

(4) Termination ofMonitqring. 

(i) If representative samples taken duri ng the initial exposure monitoring reveal an 

airborne concentration below the action level, the Company may discontinue monitoring for that 

exposure group, except when additional exposure monitoring is required by paragraph (d)(5) of 

this New Chemical Exposure Limit section. 
- 20-

(i i) If rcprcsenLative samples taken during the periodic monitoring reveal that an 

airborne concentration, as indicated by at least 2 consecutive measurements taken at least 7 days 

apart, arc below the action level. the Company may discontinue the monitoring for that exposure 

group, except when additional monitoring is required by paragraph (d)(5) of this New Chemical 

Exposure Limit section. Where the PMN substance is manufactured, processed, or used in batches 

or duration less than 7 days,' the 2 consecutive measurements may be taken at least 24 hours apart, 

provided that the measurements accurately renect the highest peak exposures and variabil ity in 

exposure. 

(5) Additional Monitoring. 

(i) For a previously monitored exposure group, the Company shall, within 7 days 

of any of the events listed below in this paragraph (d)(S)(i), conduct the initial exposure 

monitoring followed by any periodic or additional exposure monitoring required by subsection (d) 

of this New Chemical Exposure Limit section: 

(1) ch~nge in the production volume, process, control equipment, personnel 

or work practices that may reasonably cause new or additional exposures to the PMN substance; 

(II) spills, leaks, ruptures or other breakdowns occur that may reasonably 

cause new or additionnl exposures to the PMN substance; and 

(Ill) whenever else the Company has any reason to suspect a change that 

may reasonably result in new or additional exposures to the P.\IIN substance. 

(ii) In no event is the additional exposure monitoring rcquin:mcnt in paragraph 

(d)(S)(i) intended to delay implementation of any necessary cleanup or other remedial action. 

During any cleanup or remedial operations that may occur before commencing additional exposure 

monitoring, the Company shall ensure that potentially exposed persons usc at least the respiratory 
- 2 1 -

protection specified in subsection (c) for the measured airborne concentration, or more protective 

respiratory equipment deemed appropriate by the best professional j udgment of a qualified cxpc1i. 

(6) Notification or Monitoring Results. 

(i) Within 15 working days after receipt of the results of any exposure monitoring 

required by this Order, the Company shall notify each person whose exposure is represented by 

that monitoring. The notice shall identify the NCEL, the exposure monitoring results, and any 

corresponding respiratory protection required by subsection (e). Affected persons shall be notificd 

in wri ting either individually or by posting the information in an appropriate and accessible 0 0 

location. 

(ii) Whenever the NCEL is exceeded, the written notification required by the 

preceding paragraph shall describe the action being taken by the Company to reduce inhalation 

exposure to or below the NCEL, or shall refer to a document available to the person which es 

the actions to be taken to reduce exposure. 

(7) Exemption based on Objective Data. Where the Company has documented and 

reliable objective data demonstrating that, even under worst-case conditions, employee exposure to 

the P~ substance will not exceed the action level (defined in paragraph (d)(l )(i)) under the 

expected handling procedures and conditions for a spcci lie "exposure group" (deli ned in par~igraph 

(d)(l )(ii)), then that exposure group is exempt from this New Chemi cal Exposure Limit section 

(except paragraph (d)(5) "Additional Monitoring" and subsection (f) ·'NCEL Reeordkeeping'') and 

the respirator requirements in the Protection in the Workplace section of this Order. Any such 

objective data must accurately characterize actual employee exposures to the PMN substance and 

must he obtained under conditions closely resembling the types of materials, processes, control 

methods. work pracli<.:cs. and <.:nviro1unemal cond itions in the Company's current workplace 
• 22 . 

operations v.·ith lhc PMN substance. Examples of objective data that may be used to demonstrate 

that _employee exposure will not exceed the action level, even under worst case conditions, include 

information on the physical and chemical properties of the PMN substance, industry-wide studies, 

and/or laboratory test results. 

(c) Respiratory Protection . 

( l) General. Whenever the Company has conducted exposure monitoring at a workplace 

in accordance with subsection (d) of this New Chemical Exposure Limit section and the measured . . 

airborne concentration of the PM 1 substance for any person who is reasonably likely to be 

expos~d to the PMN substance by inhalation exceeds the NCEL, the Company shall provide those 

persons the respirators specified in this subsection (e) (ralher lhan the respirator(s) identified in the 

Protection in the Workplace section of this Order), and shall ensure that the respirators are used 

(including training, fit testing, and maintenance) in accordance with OSHA and NIOSI I respiratory 

protection requirements at 29 CFR 1910. 134 and 42 Cf<"R Part 84. When the Company has not yet 

measured the airborne concentration of Lhe PMN substance at a workplace in accordance with this 

New Chemical Exposure Limit section, the Company shall comply with the respirator 

requirements in the Protection in the Workplace section of this Order at that workplace. 

(2) .S.clecti_on of Appropriate Respiratory Protection. After the Company has conducted 

exposure monitoring in accordance with subsection (d) of this New Chemical Exposure Limit 

section, the Company shall select, provide, and ensure that persons who are reasonably likdy to bt: 

exposed to the PMN t~b tancc by inhalation usc, at a minimum, the respiratory protection which 

corresponds in the following table to the measured airborne concentration (or a more protective 

respirator which corresponds to a concentration higher than measured). 
Measured 

Concentration 

of PM!' Substance 

~ NCEL 

~ JO x NCEL 

~ 25 x NCEL 

~50 x NCEL 

- 23 -

PARTICULATE RESPJRA TORT ABLE 

Required Respiratory Protection 

No respiratory protection is required. 

1) Any NJOSH-certified air-purifying clastomeric half-mask respirator 

equipped with N I 00 (if oil aerosols absent), R 100, or Pl 00 filters 

(11) Any appropriate NIOSH-ccnified NIOO (if oil aerosols absent). RlOO, or 

P 100 filtering fnccpiccc respirator. [Note: for filtering facepieces, an APF 

of I 0 can only be achieved if the i·espirator is qualitatively or quantitatively 

fit tested on individual workers]. 

(111) Any NIOSH-certift ed air-purifying ful l' facepi ece respirator equipped 

with N I 00 (if oil aerosol~ absent), R I 00, or PI 00 fil ters 

(IV) Any NIOSl 1-certi lied negative pressure (demand) supplied-air 

respirator equipped wi th a half-ma~k 

(V) Any NIOSll-certified negative pressure (demand) self-contained 

breathing apparatus (SCBA) equipped with a half mask. 

(J) Any NIOSH-certified powered air-purifying respirator equipped with a 

hood or helmet and H EP 1\ fi hers. 

(II) Any NfOSH-certified powered air-purifying respirator equipped with a 

loose fitting facepiece and HEPA filters. 

(lll) Any NlOSH-ccrlificd continuou~ Oow supplied-air rc~pirator equipped 

with a hood or helmet. 

(IV) Any NIOSJ )-certified cont inu ou~ flow supplied-air respirator 

equipped with a loose filling facepiccc. 

(l) Any NIOSH-ccrtificd air-purifying full faccpiccc respirator equipped 

with N I 00 (if oil aerosols abscnl), R-1 00, or P-1 00 lihcr(s). 
~ 1000 X ~CEL 

- 24 -

(11) Any NJOSH-certiftcd powered air-purifying respirator equipped with a 

tight-fitting faccpiecc (half or full facepiece) and equipped with HEP 1\ 

fi hers 

(III) 1\ny NIOSH-ccrlified pressure-demand or other positive pressure 

mode supplied-air respirator equipped with a half-mask 

(JV) Apy NIOSH-certified negative pressure (demand) supplied-air 

respirator equipped with a fu ll faccpiccc. 

(Y) Any NIOSll-certificd continuous Oow supplied-air respirator equipped 

with a tight-fitting faccpiecc (half or full facepiece). 

(VI) Any NIOSH-certilied negative pressure (demand) self-contained 

breathing apparatus (SCBA) equipped with a hood or helmet or a full 

foceplecc.. · -

(I) Any NIOSH-certified powered air purifying full facepiece respirator 

equipped with l !EPA filters. 

(JJ) Any NIOSIJ-certified powered air-purifying respirator equipped with a 

hood or helmet* and NIOO (if oil aerosols absent), RlOO, or PlOO tilters with 

evidence demonstrating protection level ofl, 000 or greater.* [Note to 

Program Manager: Copy and paste the * and the foo tnote below the 

table wJtcn selecting this respirator.! 

(111) Any NJOSH-certifit.!d continuous now supplied-air respirator equipped 

with a full facepiece. 

(IV) Any iJOSH c~rtilied continuous flow supplied-air respirator 

equipped with a hood or helmet with evidence demonstrating protection 

level of 1,000 or greater.* 

(Y) Any NIOSl !-certified supplied-air respirator equipped with a full 

facepiece. 

*OSHA has assigned 1\PFs of 1000 for certain types of hoods and helmets 

with powered air purifying respirators (PA PRs) or supplied air respirators 

(SARs) where the manufac turer can demonstrate adequate air nows to 

maintain positive pressure inside the hood or helmet in normal working 

conditions. However, the employer must have evidence provided by the 

respirator manufacturer that the testing of these respirators demonstrates 

perform.ance at a level of protection of 1,000 or greater to receive an APF of 

1,000. This level of performance can best be demonstrated by performing a 
> 1000 X NCEL 

(max. 10,000 x 

NCEL) 

- 25 -

workplace Protection Factor (WPF) or Simulated Workplace Protection Factor 

(SWPF) study or equivalent testing. Without testing data that 

d emonstrat es a level of prot ection of 1,000 or greater, all PAPRs and 

SARs with helmet s /hoods a re to be t reated as loose-fitting · 

facepiece respirators, a nd receive an APF of 25. 

Any NIOSH-ccrtified pressure-demand or other positive pressure mode 

(e.g., opl:rtlclosed circuit) self-contained br·cathing apparatus (SCBA) 

equipped with a hood or helmet or a full facepiece. 

(3) Reductions in Respiratory Protection. After appropr iat~ respiratory protection has 

bl:<.:n $elected based on the results of actual exposure monitoring conducted at a workplace in 

·accordance with subsection (d) of this New Chemic"al Exposure Limit section: the Company shall 

not. at that workplace, use the respiratory protection required by the Protection in the Workplace 

section of this Order (unless it is the same as required by this New Chemical Exposure Limit 

section). Before the Company may make any reduction in any respiratory protection selected 

pursuant to this New Chemical Exposure Limit section, the Company must verify, by 2 

consecutive measurements taken at least 7 days apart, that the new respiratory protection is 

appropriate in accordance with paragraph (c)(2). Where the PMN substance is manufactured, 

processed, or used in batches of duration less than 7 days, the 2 co~sccutivc measurements may be 

taken at least 24 hours apart. provided that the measurements accurately reflect the highest peak 

exposures and variability in exposure. 

(4) Special Situations. 

(i) Measurements Outside Quanti tat ion Limits. When a value less than the I .QL of 

the unalytical method (as described in paragraph (c)(4)(ii)) is measured, the Company shall 

estimate potential exposure using generally cstublishcd and accepted statistical methods. If the 

Company obtains an exposure monitoring sample that is more than I 0% above the actual UQL uf 
- 26 -

the analytical method, the Company must ensure that its workers wear at least a NIOSl J-cettificd 

supplied-air respirator operated in pressure demand or other positive pressure mode and equipped 

with a tight-fitting full faccpiccc. Any reductions in this respiratory protection must comply with 

paragraph (e)(J). The Company may submit an improved analytical method provided that it 

complies fully with subsection (c) of this New Chemical Exposure Limit section, including the 

verification required by subsection (c)(3). 

(ii) Cleanup and Remedial Actions. During any special 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 potentially exposed persons use at least the 

respiratory protection specified above in this subsection(<.:) for the measured airbome 

concentration, or more protective respiratory equipment deemed appropriate by the best 

professional judgment of a qualified ex pen. 

(i) NCEL Reeordkeeping. 

(1) Whenever the Company elects to comply with this New Chemical Exposure Li.mit 

section rather than the respirator 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 shall make them available for inspection and copying by EPA in accordance with 

section II ofTSCA: 

(i) A copy of the sampling and analytical methods used and continuing evidence of 

their accuracy over time as required by sec1ion (c); 
-27-

(ii) Records documenting compliance with the analytical method verification 

requirements of subsection (c)(3), including copies of the signed c~rtification statement and the 

verification results obtained by both laboratories; 

(iii) Records documenting either compliance with the Good Laboratory Pmctice 

Standards at 40 CFR Part 792, or use of a laboratory accredited by the A If 1/\ or another 

comparable program approved in adv<mce in writing by EPA. Where the Company elects to not 

comply with TSC/\ GLPS, such records shall include the written accreditation from the AIHA or 

the written approval from EPA. 

(iv) Records documenting all exposure monitoring dales, duration, and results of 

each sample taken; 

(v) Records documenting the name, address, work shift, job classilication, and 

work area of the person monitored and of all other persons whose exposures the monitoring is 

intended to represent; 

(vi) Any conditions that might have affected the monitoring results; 

(vii) Notification of exposure monitoring results required by paragraph (d)(6); 

(viii) Records documenting any changes in the production, process: control 

equipment, personnel or work practices that may reasonably cause new or additional exposur~s to 

the PMN subs tanc~; 

(ix) Records documenting any spi lls, Jenks, ruptures or other breakdowns that may 

cause new or additional exposure; 

suhstancc; 

(x) The type of respiratOI)' protective devices worn by the monitored person. if any; 

(xi) Records documenting any actions taken to mitigate exposures to the J>:'vlN 
- 28-

(xii) Records documenting reliance on the objecti ve data exemption in paragraph 

(d)(7), including: (A) the source of the data, (B) protocols and results of any relevant testing or 

analysis, (C) a description of the operation exempted and how the data demonstrate that employee 

exposures will not exceed the action level, (D) other data relevant to the operations, materials and 

employee exposures covered hy the exemption. 

HAZARD COMMUNJCATIOJ\: PROGRAYf 

(a) Written HaZRrd Communication Program. The Company shall develop and implement a 

written h'tLard communication program for the PMN substance in each workplace. The written 

program will, at a minimum, describe how the requirements of this section for labels, MSDSs, and 

other forms of warning material will be satisfied. The Company must make the written hazard 

communication program available, upon request, to all employees, contractor employees, and their 

designated representatives. The Company may rely on an existing hazard communication 

program, including an existing program estnblished under the OSHA Hazard Communication 

Standard (29 CFR 191 0.1200), to comply with this paragraph provided that the existing hazard 

communication program satisfies the requirements of this section. The written program shall 

include the following: 

(I) A I ist of chemical substances known to be present in the work area which are subject to 

a TSCA section 5(e) co ~nt order signed by the Company or to a TSCA section 5(a)(2) SNUR at 

40 CFR Part 721, subpart E. The list must be maintained in each work area where the PMN 

substance is known to be present and must usc the identity provided on the MSDS for the 

substance required under paragraph (c) of this section. The list may be compiled for the workplace 
- 29-

or tor individual work areas. ll"the Company is required either by ~nether Order issued under 

section S(e) ofTSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpat1 E, to 

maintain a list of substances, the lists shall be combined with the list under this subparagraph. 

(2) The methods the Company will use to inform employees of the hanrds of non-routine 

tasks involving the PMN substance (e.g., cleaning of reactor vessels), and the hazards associated 

with the PMN substance contained in unlabeled pipes in their work area. 

(3) The methods the Company will use to inform contractors of the presence of the PMN 

substance in the Company's workplace and of the provisions of this Order if employees of the . . . 

contractor work in the Company's workplace <md are reasonably likely to be exposed to the PMN 

substance while in the Company's workplace. 

(b) Labeling. 

( I) The Company shall ensure that each container of the substance in the ·workplace is 

labeled in accordance with this subparagraph (b)( I). 

(i) The label shall, at a minimum, contain the following information: 

(A) A statement of the health hazards(s) and precautionary measure(s), if 

any. identified e ither in paragraph (f) of this section or by the Company, for the PMN substance. 

(B) The identity by which the PMN substance may be commonly 

recognized. 

(C) A statement of the environmental hazard(s) and precautionary 

mcasurc(s), if any, identified either in paragraph (f) of this section, or by the Company, for the 

Piv1N ubstanc~. 
- 30-

(D) A statement 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 sheets, batch tickets, operating 

procedures, or other such writ~en materials in lieu of affixing lahcls to individual stationary process 

containers, as long as the alternative method identities the containers to which it is applicable and 

conveys information specified by subparagraph (b)( l)(i) ofthis section. Any written materials 

must be readil y accessible to the employees in their work areas throughout each work shift. 

(iii) The Company need not label portable containers into whi ch the Ptvf.\! 

substance is transferred from labeled containers, and which are intended only for the immediate 

usc of the employee who performs th~ transf~r. 

(iv) The Company shall not remove or deJace an existing label on containers of the 

PMN substance obtained from persons outside the Company unless the container is immediately 

re-labeled with the information specified in subparagraph (b)(l )(i) of this section. 

(2) The Company shall ensure that each container of the substance leaving its workplace 

for distribution in commerce is labeled in accordance with this subparagraph (b)(2). 

(i) The label shall, at a minimum, contain the fo llowing information: 

(A) The information prescribed in subparagraph (b)(l)(i) ofthis section. 

(B) Tht.: name and address of the manufacturer or a responsible party who 

can provide additional information on 01e substance for hazard evaluation and any appropriate 

emergency procedures. 

(i i) The label shall not conflict with the requirements of the Hazardous Materials 

Transportation /\ct ( 18 U .S.C, 1801 ct. seq.) and regulations issued under that Act by the 

Department of Transportation. 
- 31 -

(3) The label, or alternative forms of warning, shall be legible and prominently displayed. 

( 4) The label, or alternative forms of warning, shall be printed in Eng! ish; however. the 

information may be repeated in other languages. 

(5) If the label or alternative form of warning is to he applied to a mixture containing the 

PMN substance in combination with any other substance that is either subject to another TSCA 

section S(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at40 

CFR Part 72 1, subpart E. or defined as a "ha7..ardous chemical" under the OSHA I Iazard 

Communication Standard (29 CfR 1900.1200), the Company may prescribe on the label, MSDS. . . 

or alternative form of warning, the measures to control worker exposure or environmental release 

which the Company determines provide tlw greatest degree of protection. 1 lowever, should these 

control mcnsurcs differ from the applicable measures required under this Order, the Company must 

seek a determination of equivalency for such alternative control measures pursuant to 40 CFR 

721.30 before prescribing them under this subparagraph (b)(S). 

(6) If the Company becomes aware of any significant new information regarding the 

hazards of the Pfvfl\ substance or ways to protect against the hazards, this new information must be 

added to the label within 3 months from the time the Company becomes aware of the new 

infomtation. If the PJ\IfN substance is not being manufactured (defined by statute to include 

import), processed, or useu in the Company's workplace, the Company musl add the new 

inf011nation to the label before the PMN substance is reintroduced into the workplace. 
- 32 -

(c) Material Safe_ty Data Sheets. 

(I) The Company must obtain or d~vdop an lSDS for the PMN substance. 

(2) The MSDS shall contain, at n minimum, the following information: 

(i) The identity used on the container label of the PMN substance under this 

section. and, if not claimed confidential, the chemical and common name of the PMN substance. 

Jfthe chemical and common names arc claimed confidential, a generic chemical name must be 

used. 

(ii) Physical and chemical characteristics of the substance known to the Company, . . 

(e.g., vapor pressure, flash point). 

(iii) The physical hazards of the substance known to the Company, including the 

potential for fire, explosion, and reactivity. 

(iv) The potential human ha7..ards as specified in paragraph (f) of this section. 

(v) Signs and symptoms of exposure, and any medical condition:; which arc 

expected to be aggravated by exposure to the PMN substance known to the Company. 

(vi) The primary rout~s of exposure to the PMN substance. 

(vii) Precautionary measures to control worker exposure and/or environmental 

release required by this Order, or alternative control measures which EP 1\ has determined under 40 

CFR 72 I .30 provide substcmtially the same degree of protection as the identified control measures. 

The MSDS must identify any ~ew Chemical Exposure Limits specified in paragraph (b) oflhe 

New Chemical Exposure Limit section of this Order and must contain the information specified in 

the graduated respirator table in paragraph (c)(2) of the New Chemical Exposure Limit section. 

(vii i) Any generally applicable precautions for safe handling and use of the PMN 

suhswnce which are known to the Company, including appropriate hygienic practices, protective 
- 33-

measures during repair and maintenance of contaminated equipment, and procedures for response 

to spi lls and leaks. 

(ix) Any generally applicable control measures which arc known to the Company, 

such as appropriate engineering controls, work practices, or personal protective cqtdpment. 

(x) Emergt;ncy first aid procedures known to the Company. 

(xi) The date of preparation of the MSDS or of its last revision. 

(xii) The name, address, and telephone number of the Company or another 

responsible party who can provide additional information on the chemical substance and any . . . . 

appropriate emergency procedures. 

(3) Tfno relevant information is found or known for any given category on the MSDS, the 

Company must mark the MSDS to indicate that no applicable information was found. 

(4) Where multiple mixtures containing the PM!\ substance have similar compositions 

(i.t; .. the chemit;al ingredients are essentially the same, but the specitic composition varies fro.m 

mixture to mixture) and simil:u hazards, the Company may prepare one MSDS to apply to all of 

these multiple mixtures. 

(5) Jf the Company becomes aware of any significant new information regarding the 

hazards of the PMN substance or ways to protect against 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 substance is not being manufactured (defined by statute to include 

import), processed, or used in the Company's workplace, the Company must add the new 

information to the :v!SDS before the P.Y~ substance is reintroduced into the workplace. 
- 34 -

(6) The Company must ensure that persons recei ving the PMN substance fi·om the 

Company are provided an appropriate MSDS with their initial shipment and with .the first shipment 

after an MSDS is revised. The Company may either provide the MSDS with the shipped 

containers or send it to the person prior to or at the time of shipment. 

(7) The Company must maintain n copy of the MSDS in its workplace, and must ensure 

that it is readily accessible during each work shift to employees when they arc in their work areas. 

(8) The MSDS may be kept in any f01m. including as operati ng proc~durcs, and may be 

designed to cover groups of substances in a work area where it may be more appropri ate to address . . . -

the potential hazards of a process rather than individual substances. However, in all c~ses. the 

required infom1ation must be provided for the PMN substance and must be readily accessible 

during each work shift to employees when they are in their work areas. 

(9) The MSDS must be printed in English; however, the information may be repeated in 

other languages. 

(d) EmnLoyee In formation and Tq~ inin u. The Company rnusl ensu ~ that employees are provided 

with in formation and training on the PMN substance. This information and training must be 

provided at the time of each employee's initial assignment to a work area containing the PMN 

substance and \•Vhcm:ver the PMN substance is introduced into the employee's work area for the 

first time. 

(I) The information provided to employees under this paragraph shall include: 

(i) The requirements of this section. 

(ii) Any operations in the work area where the PMN substance is present. 
- 35-

(iii) The location and availability of the written hazard communication program 

required under paragraph (a) of this section, including the list of substances required by 

subparagraph (n)( I) of this section and MSDSs required by paragraph (c) of this seclion. 

(2) The training provided to employees shall include: 

(i) Methods and observations that may be used to detect the presence or release of 

the PMN substance in or from an employee's work area (such as exposure monitoring conducted 

by the Company, continuous monitoring devices, visua l appearance, or odor of the substance when 

being released). 

(ii) The potential human health hazards of the PMN substance as specified in 

paragraph (f) of this section. 

(iii) The measures employees can take to protect themselves and the environment 

from the PMN substance, including .speci fie procedures the Company has implemented to protect 

employees and the environment from exposure to the PMN substance, inc luding appropriate work 

practices, emergency procedures, personal protective equipment, engineering controls, and other 

measures to control worker exposure and/o r environmental rdeasc required under this Order, ·or 

alternative control measures which EPA has determined under 40 CFR 721.30 provide the same 

degree of protection as the spccitied control measures. 

(iv) The requirements of the hazard communication program developed by the 

Company under this section, including an explanation of the labeling system and the MSDS 

required by this section and guidance on obtaining and using appropriate hazard information. 
- 36 -

(c) De Minimis Concentrations. The requirements of this Hazard Communication section do not 

apply to quantities of the PYIN substance that are (1) present in the work area only as a mixture 

and (2) at a concentration not to exceed 1.0 percent by weight or volume (0. I percent by weight or 

volume if the PMN substance ·is identified as a potential carcinogen in paragraph (f) of the Hazard 

Communication Program section of this Order). This exemption is not available if the Company 

has reason to believe that, during intended activities, the PMN substance in the mixtme may be 

reconcentrated above the 1.0 or 0.1 percent level, whichever applies. lf this Order contains (I) 

New Chemical Exposure Limits provisions that specify a NCEL concentration less than the de . . . 

minimis concentration Sp~;!cified here, or (2) Release to Water provisions that prohibit release to 

water or specify in-stream concentration ("N") less than the de minimis concentration specified 

here, then this de minimis exemption docs not apply to those provisions. 

(f) Human Health Pref~u ti ary Statements. The following human health precautionary 

statements shall appear on each label as specified in paJagraph (b) and the MSDS as specified in 

paragraph (c) of this section: 

(1) Human health hazard statements. This substance may cause: 

(i) respiratory complications. 

(2) IIuman hazard precautionary statements. When using this substance: 

(i) avoid breathing the substance. 

(ii) use respiratory protection, or maintain workplace airborne concentrations at or 

below an 8-hour time-weighted average of 5 mg/m3

. 
- 37-

(3) The human precautionary statement on the label prepared pursuant to paragraph (b) of 

this section must be followed by the statement: "Sec the MSDS for details."' 

(g) Exi~ting ltazard Communication Program. The Company need not take additional actions if 

existing programs and procedures satisfy the requirements of this section. 

MANUFACTURING 

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

includes import) of the PMN substance by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)( I) shall expire 75 days after promulgation 

of a final significant new usc rule ("S:"JUR") governing the PMN substance under section 5(a)(2) 

ofTSCA unless the Company is notified on or before that day of an action in a Federal Court· 

seeking judicial review of the SNUR. If the Company is so notified, subparagraph (a)( 1) shall not 

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

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

(3) l'\otice of SNUR. When EPA promulgates a tina! SNUR for the PI\1N substance and 

subparagraph (a)(l) expires in accordance with subparagraph (a)(2)', the Company shall notify each 

person whom it causes, encourages .or suggests to manufacture the PMN substance of the existence 

ofthc SNUR. 

(b) The Company shall not manufacture the PMN substance other !han as an 
- 38-

PROCES lNG 

The Company shall not process the P\tfN substance other than as an 

lJSE 

The Company shall not usc the PMN substance other than as an 

DISTRIBUTION 

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

writing any person to whom it distributes the P:VtN substance that, due to the issuance of this 

Consent Order under section 5(c) ofTSCA, the PMN substance is subject to the export notification 

requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such notice shall contain, in 

the form in which it appears in this Consent Order, the following information: (l) the PMN 

number, and (2) either (A) the specific chemical identity of the P:vtN substance, or (B) if the 

specific chemical identity s confidential, the generic chemical identity. 

(b) DistributioQ Requirements. Except after the PMN has been completely reacted, or as provided 

in paragraph (c), the Company shall distribute the PMN substance outside the Company, other than 

for disposal, only to a person who has agreed in writing prior to the date of distribution, to: 

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

issuance ofthi::; Con::;t:nl Order under section 5(e) ofTSCA, the PMN substance is subject to the 

export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 Subpart D. Such 

notice shall contain, in the form in which it appears in this Consent Order, the following 
- 39-

information: (1) the PMN number, and (2) either (A) the specific chemical identity of the PMN 

substance, or (B) if the speci fie chemical identity is confidential. the generic chemical identity. 

(2) Comply with the same requirements and restrictions required of the Company in the 

Protection in the Workplace and the New Chemical Exposure Limit sections of this Order. 

(3) Cum ply with thl! same requirements and restrictions required of the Company in the 

Hazard Communication Program section of this Order. 

(4) Not use the PMN substance other than as an [expansive additive for cement]. 

(c) Temporary Transport and Storage. Notwithstanding paragraph (b), the Company may 

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

containers provided the following three conditions nrc met: 

(I) Subsequent to any such exempt temporary transport or storage of scaled containers, the 

PMN substu c~.: may be distributed only to the Company or a person who has given the Company 

the \"'Iitten agreement required by paragraph (b). 

(2) Any human exposure resulting from opening the scaled containers and removing or 

washing out the PMN substance may occur only while the PMN substance is in the possession and 

control of the Company or a person who has given the Company the written agreement required by 

paragraph (b). 

(3) The sealed containers must be labeled in accordance with paragraph (b )(2) of the 

Hazard Communication Program section of this Order. 

(d) Recipient ~on Complian ce. If, at any time after commencing distribution in commerce of the 

PlviN suhstancc, the Company obtains knowledge that a recipient of the substance has failed to 
- 40-

com.ply with any of the conditions specified in paragraph (b) of this Distribution section or, after 

subparagraph (b)(2) expires in accordance with subparagraph (e)(l), has engagt:d in a significan1 

new use of the PMN substance (as defined in 40 CFR Part 721, Subpart E) without submitting a 

significant new use notice to EPA, the Company shall cease supplying the substance to that 

recipient, unless the Company is able to document each of the following: 

(I) That the Company has, within 5 working days, notitied the recipient in writing that the 

recipient has fai led to comply with any of the conditions specified in paragraph (b) of this 

Distribution section, or has engaged in a significant new use of the PMN substance without . . 

submitting a significant new use notice to EPA. 

(2) That, within 15 working days of notifying the recipient of the noncompliance, the 

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

aware of the terms of paragraph (b) oftliis Distribution section and will comply with those terms, 

or is aware uf the terms uf the significant new use rule for the PMN substance and will not engage 

in a significant new usc without submitting n significant new use notice to EPA. 

(3) If, after receiving a statement or assurance from a recipient under subparagraph (d)(2) 

of this Distribution section. the Company obtains knowledge that the recipi cn1 has failed to comply 

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

a significant new use of the PNfN substance without submitting a significant n(!w use notice to 

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

the tailure to comply, and shall resume supplying the PMN substance to that recipient only upon 

written notification from the Agency. 
- 41 -

(e) Sunset Following SNUR. (I) Subparagraphs (b)(2), (b)4) of this Distribution section shall 

expire 75 days after promulgation of a fina l SNUR for the PMN ~stance under section 5(a)(2) of 

TSCA, unless the Company is notified on or before that day or an action in a Federal Court 

seeking judicial review of the SNUR. If the Company is so notified , subparagraph (b)(2) of this 

Distribution se~t n shall not cxpire until EPA notifies the Company in writing that all Federal 

Court actions involving the S0JUR have been resolved and the validity of the SNUR affirmed. 

(2) When EPA promulgates a final Sl\UR for the PMN substance and subparagraph (b)(2) of this 

Distribution section expires in accordance with subparagraph (c)( I), the Company shall notify each . . . . 

person to whom it distributes the PMN substance of the existence of the S 1UR. Such notification 

must be in writing and must specifically include all limitations contained in the SNUR which are 

defined as significant new uses. and which would invoke significant new use notification to EPA 

for the Ptv1N substance. Such notice must also reference the publication of the SNUR for this 

PMN substance in either the Federal Register or the Code of federal Regulations. After 

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

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

provides such notice to the persons to whom it distributes the PM;-J substance, then the Company 

is not required to obtain from such persons the written agreement specified in paragraph (b). 
- 42-

111. RECORDKEEPING 

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

arc created and shall make thc!n available for inspection and copying by EPA in accordance with 

section ll of TSCA: 

(l) Exemptions. Records documenting that the PNf:\l substance did in fact qualify for any 

one or more of the exemptions described in Section I, Paragraph (b) of this Order. Such records 

mu ·t satisfy all the statutory and regulatory recordkecping requirements applicable to the 

excmp on being claimed by the Company. Any amounts or batches of the PMl\ substance . . . 

eligible for the expo11 only exemption in Section I, Paragraph (b)( I) of this Order are exempt from 

all the requirements in this Recordkec:ping section, if the Company maintains, for 5 years from the 

date of their creation, copies of the export label and export notice to EPA, required by TSCA 

sections l2(a)(l)(B) and 2(b~, respectively. Any amounts or batches of the PMN substance 

eligible for the research and development exemption in Section I, Paragraph (b)(2) of this Order 

arc exempt from all the requirements in this Recordkeeping section. ifthe Company maintains, for 

5 years from the date of their creation, the records required by 40 CfR 720.78(b). For any 

amounts or batches of the PM:\1 substance claimed to be eligible for any other exemption described 

in Section 1, Paragraph (b) ofthis Order, the Company shall keep records demonstrating 

qualiiication for that exemption as wdl as the records specified in paragraphs (2) and (3) below, 

but is exempt from the other rccordkeeping requirements in this Recordkeepi ng section; 

(2) Records documenting the manufacture (which includes import) volume of the PM. 

substance and the correspondi.ng dates of manufacture: 

(3) Records documenting the names and add resses (including shipment destination 

address, if different) of all persons outside the site of manufacture (which includes import) tv 
- 43 -

whom the Company directly sells or transfers the PMJ\ substance. the date of each sale or transfer. 

and the quantity of the substance sold or transferred on such date; 

(4) Records documenting the address of all sites of manufacture (which includes import), 

processing, and use; 

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

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

section of this Order: 

(6) Records required by paragraph (f). of the New Chemical Exposure Limits section of ~ . .. . . 

this Order, if applicable; 

(7) Records documenting establishment and implementation of the hazard communication 

program required by the I Tazard Communication Program section of this Order: 

(8) Copies of labels required under the Hazard Communication Program section of this 

Order: 

(9) Copies of \1aterial Safety Data Sheets required by the Hazard Communication 

Program section of this Order; 

(I 0) Records documenting compliance with any applicable manufacturing, processing. 

use, and distribution restrictions in the Manufacturing, Processing, ~se, and Distribution sections 

of this Order, including distributces' written abrrecment to comply with the Distribution section of 

this Order; 

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

section of this Order. if appl ic bl ~; and, 

( 12) The Company shall keep a copy of this. Order at each of its sites where the PM N 

substance is manufactured (which includes imp t1 . 
- 44-

(b) ·Apnlicahiliw. The provisions of this Recordkeeping Section are applicable only to ac tivities 

of the Company and its Contract Manufacturer, if applicable, and not to activities of the 

Company's customers. 

(c) .OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this '·collection of 

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

Management and Budget ("OMB"), and l::P 1\ so informs the Company. The ··collection of 

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

OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-11\SPECTION Il'iFORMATION 

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

may occasional ly conduct on-site compli ance inspections of Company faci lities and conveyances 

associated with the PMN substance. To facilitate such inspections, EPA pcrsoJmcl may contact the 

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

inspections. Such requests may be written or oral. The types of information that EPA may n.:qul!st 

include, but arc not limited to, the following: 

(I) Expected dates and times when the! PM~ substance will be in production within the 

subsequent I 2 months: 

(2) CuJTent workshift schedules for workers who arc involved in activities associated with 

the PMN substance and may reasonably he exposed to the PlvfN substance: 
- 45-

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

with the PMN substance and may reasonably be exposed to the PMN substance; 

(4) Existing exposure monitoring data for workers who nrc involved in activities 

associated with the PMN substance and may reasonably be exposed to the PMN substance; 

(5) R~cord s required by the Record keeping section of this Order; and/or. 

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

conducling an inspection for that purpose. 

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

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

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

known to or reasonably ascertainable by the Company at the time of the request, the Company's 

respon::;c shall demonstrate a good faith etfort to provide reasonably accurate and detailed answers 

to all of EPA 's requests. 

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

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of 

TSC/\ and 40 CfR Part 2. 
- 46 -

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scone. This section sets forth the prol:edures by which the Company's rights and obligations 

under this Order may be transferred when the Company trunsfers its interests in the Pl\1N 

substance, including the right to manufacture the PMJ\ substance. to another person outside the 

Company (the "Successor in Interest"). 

(b) Relmion of Transfer Date to otice of Commencement ("NOC"). 

(I) Before NOC. lf the transfer from the Company to the Successor in Interest is effective . . 

before EPA receives a notice of commencement of manufacture or import (''NOC") for the PMN 

substance from the Company pursuant 10 40 CFR 720.1 02, the Successor in Interest must submit a 

new PMN to EPA and comply fully with Section S(a)( l) ofTSCA and 40 CFR part 720 before 

commencing manufacture (which includes import) of the PMN substance. 

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

after EPA receives a NOC, the Successor in Interest shall comply with the te1ms of this Order and 

shall not be required to submit a new PM N to EPA. 

(c) Dcl.initi.ons. The following definitions apply to this Successor Liability section of the Order: 

(1) "Successor in Interest" means a person outside the Company who has acquired the 

Company's full interest in the rights to manufacture the PMN substance, including all ownership 

rights and legal liabilities, tlu·ough a transfer document signed by the Company, as transferor, and 

the Successor in Interest, as transferee. The term excludes persons who acquire less than the full 

interest of the Company in the PMN substance, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substance. A Successor in 
- 47-

Interest must be incorporated. li censed, or doing business in the United States in accordance with 

40 erR 720.22(a)(3) and 40 CFR 720.3(z). 

. 0) '·Transfer Document'" means the legal instrument(s) used to convey the interests in the 

PMN substance, including the right.to manufacture the PMN substance, from the Company to the 

Successor in Interest. 

(d) Notices. 

(l) Notice to Successor in Interest. On or before the effec tive date of the transfer. the 

Company shall provide to the Successor in lnlerest, by registered mail, a copy of the Consent 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment B 

to this Order. 

(2) Notice to EPA. Within I 0 business days of the effective date of the transfer, the 

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

at: 

Postal Mail Address 

U.S. Environmental Protection Agency 

J ew Chemicals Management Branch (7405M) 

1200 Pennsylvania Avenue, N.W. 

Washington, D.C. 20460 
- 48-

Alrernntively, the document may he submitted_by courieG 

U.S. Environmental Protection Agt!ncy 

New Chemicals Management Branch (7405M) 

1201 Constitution Avenue, N.W. 

Wushington. D.C. 20004 

(3) Transfer Document. Copies of the Transfer Document must be maintained by the 

Successor 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 

pursuant to Section 11 ofTSCA, must state the effective date of transfer, 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 Interest. 

(e) Liability. 

(I) The Company shall be liable for compliance with the requirements or this Order until 

the effective date of the transfer described above. 

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

Order eiTective as of the date of transfer. 

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

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

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

in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order. 
-49 -

VI. .\10DIFTCATION AND REVOCATION OF CONSENT ORDER 

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

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

substance, to modify or revoke substantive provisions of this Order: The exposures and risks 

identified by EPA during its review of thL: P.tvfN substance and the information EP I\ determined to 

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

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

information available at the time the Agency makes that determination, including. where 

appropri ate, any reassessment of the test data or other information that supports the fi ndings in this 

Order. an examination of new test data or other information or analysis, and any other relevant 

infom1ation. 

EP I\ will issue n moditication or revocation if EPA determines that the activities proposed 

therein will not present an unreasonable risk of injury to health or tl~ e environment and will not 

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

absence of data sufficient to permit a reasoned evaluation of the health or environmental cffL:(;tS of 

the P:\111'\ substance. 

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

language of this Order. EPA will issue such a modification if EPA determines that the 

modification is useful, approptiatc. and consistent with the structmc and intent of this Order as 

issued. 
-50-

V.II. EFFECT OF CONSENT ORDER 

(u) Waiver. Ry consenting to the entry of this Order, the Company waives its rights to tile 

objections to this Order pursuant to section S(c)( I )(C) ofTSCA, to receive service of this Order no 

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

to challenge the validity ofthis Onkr in any subs~ quent action. Consenting to the e11try of this 

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

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

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

(b) CBJ Brackets. By signing this Order, the Company represents that it has carefully reviewed 

this document and hereby agrees that all information herein that is claimed as confidential by the 

Company (per section 14 ofTSCA, 40 C~R Part 720 Subpart E, and 40 CPR Part 2) is correctly 

identified within brackets and that any information that is not brackett!d is not claimed as 

confidential. To make this document available for public viev .. •ing, EP/\ will remove only the 

information contained within the brackets. 

o I ~\X 2els- oaw 

~ - - - --- Ph.D., Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 
A TT ME~T A 

DEFINITIONS 

f Note: The attached Order may not contain some oft he terms dejined below.} 

"Chemical name" means the scienti fie designation of a chemical substance in accordance 

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

nomenclature, or a name which will clearly identify a chemical substance for the purpose or 

conducting a hazard evaluation. 

. "Chemical protective clothing" means items of clothing that provide a protective barrier to 

prevent dermal contact with chemical substances of concern. Examples can include, but are nol 

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

"Company'~ means the person or persons subject to this Order . . 

"Commercial use" means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting contractqr). 

"Common name" means any designation or idcnti fication such as code name, code number, 

trade name, brand name, or generic chemical name used to identify a chemical substance othtr 

than by its chemical name. 

"Consumer" means a private individual who uses a chemical substance or any product 

containing the chemical substance in or around a permanent or temporary household or residence, 

during recreation, or for any personal use or enjoyment. 

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

sold or made availab!C to consumers for their use in or around a permanent or temporary 

household or residence. in or around a school. or in recreation. 

'·Container'' means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. f-or purposes of this section, pipes or piping 

systems, and engines, fuel tanks, or other operating systems in a vehicle, are not considered to be 

containers. 

"Contract Manufacturer" means a person, outside the Company, who is authorized to 

manufacture (which includes import) the PMN substance under the conditions specified in Part II. 

of this Consent Order and in the Consent Order for Contract Manufacturer. 

"Identity" means any chemical or common name used to identify a chemical substance or a 

mixture containing that substance. 
2 

" Immediate use." A ~;hemical substance is for the "immediate use" of a person if it is under 

the control of. and used only by, the person who transferred it from a labeled container and will 

only be used by that person within the work shift in which it is transferred from the labeled 

container. 

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

substance causes no chemical or mechanical degradation, permeation, or penetration of the 

chei1lical protective clothing under the conditions of, and the duration of, exposure. 

"Manufacture" means to produce or manufacture in the United States or impo11 into the 

customs teni tory of the United Stutes. 

"Manufacturing stream" means all reasonably anticipated transfer, flow, or disposal of a 

chemical substance, regardless of physical state or concentration, through all intended operations 

of manufacture, including the cleaning of equipment. . . 

"MSDS" means material safety data sheet. the written listing of data for the chemical 

substance. 

"N lOSH" means the National Institute lor Occupational Safety and Ilealth of the U.S. 

Department of I fcalth and Human Services. 

"Non-enclosed process" means any equipment system (such as an open-top reactor, storage 

tank, or mixing vessel) in which a chemical substance is manun\ctured, processed, or otherwise 

used where significant direct contact of th~;; bulk chemical substance and the workplace air may 

occur. 

"Non-indusu·ial usc:' means use other than at a fac ility where chemical substances or 

mixtures are manufactured or processed. 

«PMN substance" means the chemical substance described in the Prcmanufacturc notice 

submitted by the Company relevant to this Order. 

"Personal protective equipment" means any chemical protective clothing or device placed 

on the body to prevent contact with, and exposure to, an identified chemical substance or 

substances in the work area. Examples include, but arc not limited to, chemical protective 

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

various types of respirators. Barrier creams are not included in this definition. 

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

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

processing, including the cleaning of equipment. 

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

the Good Laboratory Practice Standards at 40 CFR Pan 792 without prior or subsequent Agt::ncy 
J 

review that prevents a reasoned evaluation of the health or environmental effects of the Pl\llN 

substance. 

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

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

inconclusive, internally inconsistent, or otherwi:;c insufficient to permit a reasoned evaluation of 

the potential risk of injury to human health or the environment of the PMN substance. 

"Sealed container" means a closed container tha t is physically and chen1ically suitable for 

long-term containment of the PMN substance, and from which there w111 be no human exposure to, 

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

"Use stream" means all reasonably antic ipated transfer, 1low, or disposa l of a chemical 

substance, regardless of physical state or concentration, through al l.intendcd operations of 

industrial. commercial. or consumer use. 

"Waters or the United States'' has the meaning set forth in 40 CFR 122.2. 

"Work area" means a room or defined space in a workplace where the PMN substamx: is 

manufactured, processed, or used and where employees arc present. 

"Workplace'' means an establislunent at one geographic location containing one or more 

work areas. 
Company (Transferor) 

ATTACHMENT B 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(c) CO~SENT ORDER 

PMN Number 

I. Transfer of Manufacture Ri ghts. Effective on , the Company did sell or 

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

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

rhc subject of a prcmanufacturc notice ("PlvfN") and is governed by a Consent Order issued by the 

U.S. Environmental Protection Agency ("EPA") under the autho.rity of §5(<::) of tht! Toxic . 

Substances Control Act ("TSCA." 15 U.S.C. §2604(e)). 

2. Assumption ofLinhility. The Successor in Interest hereby certifies that, as of the effective date 

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

manufacture. processing. use, distribution in commerce and disposal of the PN1N substance. shall 

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

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

720.22(a)(3). 

3. Confidential Dusincss Information. The Successor in Interest h~rcby: 

reasserts - , 

_ relinquishes, or 

modifies 

all Confidential Business Information ("CBl' ') claims made by the Company, pursuant to Section 

14 ofTSCA and 40 CFR part 2, for the PMN substance(s). Where "reasserts" or ''relinquishes" is 

indicated. that designation shall be deemed to apply to all such claims. Where "modifies" is 

indicated, such modification shall be explained in detail in an attachment to this Notice of 

Transfer. Information whi ch has been previously disclosed to the public (e.g., a chemical identity 

that was not claimed as CBI by the original submitter) would not subsequently be eligible for 

confidential treatment under this Notice of Transfer. 
NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

(continued) 

Company (Transferor) PMN Number 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Successor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, Stale. Zip Code 
NOTICE OF TRANSFER OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(c) CONSENT ORDER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone 
ATTACHMENT C 

STATISTICAL ANALYSIS OF NCELs ANALYTICAL METHOD 

VERIFICATION RESULTS 

This Attaclunent describes the statistical tcclmique (with examples) for comparing the 

analytical results obtained by two laboratories pursuant to paragraph (c)(3)(vii) of the New 

Chemical Exposure Limit section of this Order. 

STATISTICAL TECHNIQUE 

To obtain two-sample t test with unequal variances, perform the following operations: . . . 

• Compute means of the data measured by two laboratories. 

• Compute mean squares 

• Form U1e ratio 

• Compute degrees of freedom 

vvhcrc, 

-

Xt =Average of the results from the company laboratory 

-

X2 =A vcrage of the results from the independent laboratory 

n1 =Number of samples analyzed by the company laboratory 

n2 =Number of samples analyzed by·the independent laboratory. 
IV 

Then compare the absolute value ofT to the 97.5 percentile point of a t distribution with f 

degrees of freedom . If the absolute value exceeds the 97.5 percentile point, the results measured 

by two laboratories are significantly different at 95% level. Otherwise, they are not significantly 

different. In general, fmay not be an integer. Use interpolation to obtain the 97.5 percentile 

point of at distribution with f degrees off e~ orn . 

EXAMPLES -- The following examples (based on simulated data) illustrate the method: 

Example 1 

-

x, = 83.30 

Data Set 1 

80.56 

100.01 

86.04 

52.61 

84.85 

95.75 

Absolute value ofT= 2.467 

-

x2 = 1 oo.4o 

s} ;:;: 9.26 

f=5.33 

Data Set 2 

97. 11 

102.1 3 

99.83 

97.83 

105.44 

100.04 

The t table shows that the 97.5 percentile point is 2.57 1 and 2.447 for 5 and 6 degrees of 

freedom, respectively. For 5.33 degrees of freedom, the 97.5 percentile point will be 

approximately 2.530 which is greater than the absolute value ofT, 2.467. Hence, the means of 

two data sets are not significantly different at the 5% level. 

However, if this problem had been treated as an ordinary two-sample t test, the means 

would be significantly different at the 5% level because the absolute ofT is greater than 2.228, 

the 97.5 percentile point for the t distribution with 10 degrees of freedom. 

Example 2 

Data Set I 

82.87 

101.85 

87.44 

99.68 

I 01.15 

99.2 1 

_Data Set.2 

108.05 

96.51 

100.04 

104.33 

110.32 

107.00 
v 

- - X1 = 95.37 n1 = 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 shows 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 less than the absolute value ofT, 2.290. Hence, the means of two 

data sets are significantly different 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-15-0254 

Report Status: Completed 

Status Date: 04/23/2015 04:31 :28 PM 

Fate Assessor: 

Fate Summary Statement: 

L-15-0254 

FATE: 

Solid with MP = Dec. 133 •c (M) 

s > 1 o giL at 25 ·c (E) 

VP < 1.0E-6 torr at 25 •c (E) 

H < 1.00E-8 (E) 

POTW removal (%) = U; OECD 301B(Ciosed Btl): 20%(avg)/28d. 

Time for complete ultimate aerobic biodeg = U 

Sorption to soils/sediments = U 

PST Potential: P281 

'CEB FATE: Migration to ground water= U 

Physical Properties: 

Property Measured I Calculated Value 

Molecular Form: C18 H40 Mn2 N6 02. C2 H4 

0 2 . 2CI 

Molecular WI: 612.39 

% < 500 

% < 1000 

--

EPI 

N/A I 

N/A 

" 

Property Measured Value Method Estimated Value Method 

Melting Point: Dec. ca. 133 MSDS 

Boiling Point: 

BP Pressure: N/A 1@760 N/A . Vapor <0.000001 Salt 

Pressure: 

Water >385 Formulation 

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 

Henry's Law: N/A N/A N/A N/A 

- -

t~:Comment : ££& &£% &L E£ 2 f 

Fate Analysis: 

Hydrolysis (11 /2, ~olatiliza ion Volatilization 

~a): t1/2)-River t1 /2)-Lake(da} 

hr): 

jAtm Ox Potential m Ox Potential f"tmOx 

EPI 

1@760 

N/A 

i' 

" ' _ , 

J¥i£f,£ £±£ £& "' 
(t1/2)0H (hr}: (J1 /2)03(hr: Potential(t 1/2) 

jrotal (hr): 

MITI Linear: MIT! Nonlinear: 

Biodeg Linear: Biodeg 

Nonlinear: 

Biodeg Survey ult: Biodeg Survey 

Prim: 

STP (% removal} STP (% removal) 

tTotal: Biodeg: 

STP (% removal} 

!Acts: 

STP (% removal) 

lAir: ~ 

PST Ratin s: 

Persistence Bioaccumulation Toxicity PST Comments 

(1) 2 (1) 1 (1) Awaiting Human (1) 

Health Entry 

(2) (2) (2) Awaiting Human (2) 

Health Entry 

3) 3) 3) Awaiting Human 

~ealth Entry . 

3) 

4) 4) 4) Awaiting Human 

Health Entry 

4) 

5) 5) 5) Awaiting Human 5) 

. ~ea th Entry 

Exposure-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 Moderate Strong V. Strong 

WWT/POTW Stripping 4 Extensive Moderate Low Negligible 

Biodegradation Removal: 4 Unknown High Moderate Negligible 

Biodegradation Destruction: Unknown Complete Partial - Aerobic Biodeg Ult: u <=Days Weeks Months >Months 

Aerobic Biodeg Prim: <=Days Weeks Months >Months 

Anaerobic Biodeg Ult: u <=Days Weeks Months >Months 

Anaerobic Biodeg Prim: <=Days Weeks Months >Months 

Hydrolysis (t1/2 at pH 7,25C) A: <=Minutes Hours Days >=Months 

Hydrolysis (t1/2 at pH 7,25C) 8: <=Minutes Hours Days >=Months 

Sorption to Soils/Sediments: u V. Strong Strong· Moderate Low 

Migration to Ground Water: u Negligible Slow Moderate Rapid 

Photolysis A. Direct: Negligible Slow Moderate Rapid 

Photolysis 8, indirect: Negligible Slow Moderate Rapid 

Atmospheric Ox A, OH: Negligible Slow Moderate Rapid 

Atmospheric Ox B, 03: Negligible Slow Moderate Rapid 

Bio Comments: OECD 301B(Ciosed Btl}: 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 04/23/2015 

Human Health Rpt Created by Kendra Moran on 04/24/2015 

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 

--------;D::--o--=cu=m=e;:;:: n;,::: t Created by Thomas Webb on 04/23/2015