UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

In the matter of: 

Kior, Inc. 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

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Premanufacture Notice Number: 

P-11-327, P-11-328, P-11-329, 

P-11-330, P-11-331 and P-11-332 

Consent Order and Determinations Supporting Consent Order 
11 

TABLE OF CONTENTS 

Preamble 

1. Introduction 

II. Summary of Terms of the Order 

III. Contents ofPMN 

IV. EPA's Assessment of Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health and Environmental Effects 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Submission and Evaluation ofInformation 

III. Recordkeeping 

IV. Requests for Pre-Inspection Infomlation 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Statistical Analysis ofNCELs Analytical Method Verification Results 

Attachment C - Notice of Transfer of Consent Order 
111 

PREAMBLE 

I. INTRODUCTION 

Under the authority of § 5(e) ofthe Toxic Substances Control Act ("TSCA") (15 U.S.C. 

2604(e», the Environtnental Protection Agency ("EPA" or "the Agency") issues the attached 

Order, regarding premanufacture notices ("PMN") P-ll-0327, P-ll-0328, P-ll-0329, P-ll0330, P-II-0331 and P-ll-0332 for the chemical substances: Distillates (lignocellulosic), C5-40 

(PI 1-0327) , Paraffin waxes (lignocellulosic), C5-40, cyclic and linear (P-ll-0328), Naphtha 

(lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (P-II-0329), Kerosene 

(lignocellulosic), hydrotreated, C8-16-branched, cyclic and linear (P-II-0330), Distillates 

(lignocellulosic), hydrotreated, C8-26 - branched, cyclic, and linear (pc ll-0331) and Residual 

oils (lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear (P-II-0332) ("the PMN 

substance") submitted by Kior, Inc.("the Company"), to take effect upon expiration of the PMNs 

review period. The Company submitted these PMNs to EPA pursuant to § 5(a)(1) of TSCA and 

40 CFR Part 720. 

Under § 15 of TSCA, it is unlawful for any person to fail 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 pursuant to § 16, and to specific enforcement and seizure 

pursuant to § 17. In addition, chemical substances subject to an Order issued under § 5 of 

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

II. SUMMARY OF TERMS OF THE ORDER 

The Consent Order for these PMN substances requires the Company to: 

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

Protection Factor ("APF") of 10,000; 

(b) as an altemative to using respirators, maintain workplace airborne concentrations of these 

PMN substances at or below a specified New Chemical Exposure Limit ("NCEL") of 0.32 

mg/m3

, v.erified 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 submitted to EPA); 

(c) distribute the PMN substance only to a person who agrees to follow the samerestrictions 

(except the testing requirements); 

(d) Comply with the Release to Water Provisions; and 

(e) Maintain certain records. 
v 

III. CONTENTS OF PMNs 

By signing this Order, the Compan"y represents that it has carefully reviewed this document and 

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

identified within brackets and that any information 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 Preamble and Order): 

Representative Chemical structure, Production volume, Manufacturing sites, and Category of use 

is CBI only for Pll-327 and PIl-328. 

Chemical Identity: P-ll-0327 

Specific: Distillates (lignocellulosic), C5-40 

Specific: [" 

Generic: Distillation feedstock after hydrotreatment 

Maximum 12-Month Production Volume: [' yr] 

Chemicalldentity: P-ll-0328 

Specific: Paraffin waxes (lignocellulosic), C5-40, cyclic and linear 

Specific: [. 

Generic: Feedstock 

Maximum 12-Month Production Volume: [. Iyr] 
vi 

Chemical Identity: P-ll-0329 

Specific: Naphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear 

Specific: Hydrotreated Lignocellulosic Naphtha will be used as blendstock for conventional fossil fuels 

Maximum 12-Month Production Volume: [ 

Chemical Identity: P-ll-0330 

Specific: Kerosene (lignocellulosic)" hydrotreated, C8-16-branched, cyclic and linear 

Specific: Hydrotreated Lignocellulosic Kerosene will be used as blendstock for conventional 

fossil fuels. 

Maximum 12-Month Production Volume: [ __ J 

Chemical Identity: P-ll-0331 

Specific: Distillates (lignocellulosic), hydrotreated, C8-26 - branched, cyclic, and linear 

Specific: Hydrotreated Lignocellulosic Distillate will be used as blendstock for conventional fossil 

fuels 

Maximnm 12-Month Production Volume: [ 

ChemicaIIdentity: P-U-0332 

Specific: Residual oils (lignocellulosic), hydrotreated, C20-40- branched, cyclic, and linear 

Sp~cific: Intended for use in a manner comparable to gas oil as it is currently used in industry 

Maximum 12-Month Production Volume: [ J 
Vll 

IV. EPA'S ASSESSMENT OF RISK 

The following are EPA's predictions regarding the probable human toxicity, human 

exposure and environmental releases of these PMN substances, based on the information 

currently available to the Agency. 

Human Health Effects Summary: 

Absorption: Absorption of some (unspecified) PMN constituents is good all routes, based on 

physical/chemical properties. 

Toxicological Endpoints of Concern: There are concerns for solvent irritation and solvent 

neurotoxicity. There is also concern for dermal and respiratory sensitization, based on styrene 

and information in the PMN MSDS(s). There are also concerns for immunotoxicity based on 

benzene, phenol, styrene and toluene, and mutagenicity based on phenol, toluene, methyl vinyl 

ketone, and benzofuran. There is also concern for oncogenicity based on benzenes. 

Basis: The primary health concerns for the PMNs have been oncogenicity, immunosuppression, 

and skin sensitization (defatting of the skin tissue). These PMNs are complex mixtures and as 

such have been toxicologically assessed based on the toxic components within their mixture that 

raise issues concerning risk to human health. The most important and primary component 

present is benzene. Benzene is a known human carcinogep. as well as an agent that has been 

shown to cause immunosuppression in humans. The EPA Maximum Contaminate Level (MCL) 

for benzene in drinking water is 5 ppb. Secondary to benzene there were several other 

components present that included toluene (methyl-benzene), xylene (Dimethyl benzene (ortho, 

meta, and para»), ethyl-benzene, and styrene. All of these additional components are believed to 

have a lesser role in initiating human toxicity than benzene. Thus the focus ofthis lisk 
viii 

assessment is on benzene. 

Environmental Effects Summary: 

Based on Quantitative Structural Activity Relationship ("QSAR") analysis derived from test 

data on structurally similar neutral organics, See 

www.epa.gov/opptintr/newchems/pubs/chemcat.htu1 EPA expects toxicity to aquatic organisms 

in surface waters to occur from these PMN substances at 82 ppb for PII-329 and PI1-331; and 

180 ppb for P 11-327, PII-328, P 11-330, and PII-332. EPA does not expect risk to aquatic 

organisms at the expected levels and duration of exposure as described in the PMNs. 

Exposure and Environmental Release Summary: 

Pll-327 

Mannfacture 

[ :] [l ] [J _1 

# Sites 1 I 1 

Workers 3 3 3 

(#/site) 

Exposure 365 365 365 

(days/year) 

Dermal Exposure 880 880 880 

(mg/day) 

Inhalation Exposure 4.9 4.9 4.9 

(mg/day) 

Inhalation Dose 3.87E-4 2.73E-3 2.73E-3 

(mg/kg/day) 

Releases (days/year) 0 O· 365 

Release to Water 0 0 1.1 

(kg/day) 
IX 

PIl-328 

Manufacture Use 

[. 1 [ [ 1 

# Sites I I I I 

Workers 3 3 3 3 

(#/site) 

Exposure 365 365 365 365 

(days/year) 

Dermal Exposure 1800 880 880 1800 

(mg/day) . 

Inhalation Exposure 3.9E+2 0.16 0.16 3.9E+2 

(mg/day) 

Inhalation Dose 'S.27E-2 2.65E-3 2.65E-3 8.2E-4 

(mg/kg/day) 

Releases (days/year) 0 0 365 0 

Release to Water 0 0 1.1 0 

(kg/day) 
x 

Pll-329 

Manufacture Process 1 Process 2 Use 

[ I] [ ] [ ] 

# Sites 2 1 2 235 

Workers 12 3 6 705 

(#/site) 

Exposure 365 365 365 365 

(days/year) 

Dermal Exposure 1800 1800 1800 180 

(mg/day) 

Inllalation Exposure 5.05E+5 8600 2.40E+6 4.3e+4 

(mg/day) 

Inhalation Dose 3.90E-2 l.37E-3 3.1 OE-l 2,41E-3 

(mg/kg/day) 

Releases (days/year) 365 0 0 0 

Release to Water 0.54-1.1 0 0 0 

(kg/day) 
Xl 

Pll-330 

I 

Manufacture Process 1 Process 2 Use 

r r ;] [ 

# Sites 2 1 2 53 

Workers 12 3 3 159 

(#/site) 

Exposure 365 365 365 365 

(days/year) 

Dennal Exposure 1800 1800 1800 . 180 

(mg/day) 

Inhalation Exposure l.1E+5 1800 l.lE+6 4.2E+4 . 

(mg/day) 

Inhalation Dose 8.09E-3 2.65E-4. 6.9IE-2 .2.33E-3 

(mg/kg/day) 

Releases (days/year) 365 0 0 0 

Release to Water· 0.54-1.1 0 0 O. 

(kg/day) 
xu 

Pll-331 

Manufacture Process 1 Process 2 Use 

[ I [ ] r J -

# Sites 2 1 2 185 

. 

Workers 12 3 6 3 

(#/site) . 

Exposure 365 365 365 365 

(days/year) 

Dermal Exposure 1800 1800 1800 180 

(mg/day) . 

Inhalation Exposure 3.5E+4 7.5E+2 2.lE+5 3.7E+3 

(mg/day) 

Inhalation Dose 8.82E-3 9.27E-4 2. 13E-2 2.09E-4 

(mglkg/day) 

Releases (days/year) 365 0 0 0 

Release to Water 0.54-1.1 0 0 0 

(kg/day) 
Xlll 

Pll-332 

Mannfacture Process 1 Process 2 Use 

l [ I l J 

# Sites 2 1 2 53 

Workers 3 13 3 159 

(#/site) 

Exposure 365 365 365 365 

(days/year) 

Dennal Exposure 1800 1800 1800 180 

(mg/day) . 

Inhalation Exposure negligible negligible negligible negligible 

(mg/day) 

Inhalation Dose 1.13E-3 2.65E-4 l.30E-5 5.35E-5 

(mg/kg/day) 

Releases (days/year) 0 0 . 0 0 

Release to Water 0 0 0 0 . 

(kg/day) 
XIV 

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 immunotoxicity, carcinogenicity, and 

hydrocarbon pneumonia from exposure to these PMN substances. In addition, EPA is unable to 

determine the potential for chronic toxicity to aquatic organisms from exposures to these PMN 

substances. EPA therefore concludes, pursuant to § 5( e) (1 ) (A) (i) of TSCA, that the information 

available to the Agency is insUfficient to permit a reasoned evaluation of the human health and 

environmental effects of the PMN substance. 

(b) In light of the potential risk of immunotoxicity, carcinogenicity, and hydrocarbon pneumonia 

posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and 

disposal of these PMN substances,EP A has concluded, pursuant to § 5( e )(1 )(A)(ii)(I) of TSCA, 

that uncontrolled manufacture, impOli, processing, distribution in commerce, Use, and disposal of 

these PMN substances may present an unreasonable risk of injury to human health and the 

enlvironment. 

VI. INFORMATION REQUIRED TO EVALUATE HEALTH AND ENVIRONMENTAL 

EFFECTS 

Pended Testing. The following additional infOlwation on each PMN would be required 

to evaluate the following effects which may be caused by these PMN substances: 

Infonnation/Effects Guidelines 

Combined Chronic Toxicity/Carcinogenicity OPPTS 870.4300 
Aquatic Inveliebrate Chronic toxicity 

test, fi'eshwater daphnids 

(Flow-through conditions/ 

measured concentrations) 

Fish acute toxicity 

(Flow-through conditions/ 

measured concentrations) 

xv 

OPPTS 850.1300 

OPPTS 850.1400 

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

. production volume. However, the Order's restrictions on manufacture, impOli, processing, 

distribution in commerce, and use 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 

WASHINGTON, D.C. 20460 

CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

OFFICE OF CHEMICAL SAF'ETY 

AND POLLUTION PREVENTION 

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

distIibution in commerce, use and disposal of the chemical substances: distillates 

(lignocellulosic), C5-40 (PI 1-0327); paraffin waxes (lignocellulosic), C5-40, cyclic and linear 

(P-II-0328); rnaphtha (lignocellulosic), hydrotreated, C5-12-branched, cyclic and linear (P-I 1-

0329); kerosene (lignocellulosic), hydrotI·eated, C8-16-branched, cyclic and linear (P-I 1-0330); 

distillates (lignocellulosic), hydro treated, C8-26 - branched, cyclic, and linear (P-II-0331); and 

residual oils (lignocellulosic), hydrotI"eated, C20-40- branched, cyclic, and linear (P-l 1-0332) 

("the PMN substances") in the United States by Kior, Inc.("the Company"), except to the extent 

that those activities are exempted by paragraph (b). 

Internet Address (URl) • http.l/www,epa.gov 

Recycled/Recyclable' Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 
- 2 -

(b) Exemptions. Manufacturing, processing, distribution in commerce, use and disposal of these 

PMN substances is exempt from the requirements of this Order (except the requirements in the 

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

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

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

recordkeeping as required in the Recordkeeping section of this Order. 

(1) Export. Until the Company begins commercial manufacture ofthese PMN 

substances for use in the United States,the requirements of this Order do not apply to 

manufacture, processing or distribution in commerce of these PMN substances solely for export 

in accordan.ce with TSCA §12(a) and (b), 40 CPR 720.3(s) and 40 CPR Part 707. However, 

once the Company begins to manufacture these PMN substances for use in the United States, no 

further activity by the Company involving these PMN substances are exempt as "solely for 

export" even if some amount of these PMN substances are later exported. At that point, the 

requirements of this Order apply to all activities associated with these PMN substances while i.n 

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

of these PMN substances that are destined for export are subject to tenns ofthe Order, and count 

towards any production volume test triggers in the Testing section of this Order. 

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

manufacturing, processing, distribution in commerce, use and disposal of these PMN substances 

in small quantities solely for research and development in accordance with TSCA §5(h)(3), 40 

CPR 720.3(cc), and 40 CPR 720.36. The requirements of this Order also do not apply to 

manufacturing, processing, distribution in commerce, use and disposal ofthese PMN substances 
- 3 -

when manufactured solely for non-commercial research and development per 40 CFR nO.30(i) 

and TSCA §5(i). 

(3) Byproducts. The requirements ofthis Order do not apply to these PMN substances 

when they are produced, without separate commercial intent, only as a "byproduct" as defined at 

40 CFR nO.3(d) and in compliance with 40 CFR nO.30(g). 

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

these PMN substances when they are manufactured, pursuant to any of the exemptions in 40 

CFR nO.30(h), with no commercial purpose separate from the substance, mixture, or article of 

which they are a part. 

(5) Imported Articles. The requirements of this Order do not apply to these PMN 

substances when they are imported as part of an "article" as defined at 40 CFR nO.3( c) and in 

compliance with 40 CFR nO.22(b )(1). 

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

Exemption ("TME") under TSCA §5(h)(1) and 40 CFR nO.38 or a Low Volume Exemption 

("LVE") or Low Release and Exposure Exemption ("LoREX") under TSCA §5(h)(4) and 40 

CFR n3.50(c)(1) iilld (2) respectively, any such exemption is automatically rendered null and 

void as of the effective date of this Consent Order. 
- 4 -

II. TERMS OF MANUFACTURE, IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND. DISPOSAL 

PENDING SUBMISSION AND EVALUATION OF INFORMATION 

PROHIBITION 

The Company is prohibited from manufacturing, importing, processing, distributing in 

commerce, using, or disposing of these PMN substances in the United States, for any nonexempt 

commercial pm-pose, pending the development of information necessary for a reasoned 

evaluation of the human health and environmental effects of these substances, and the 

completion of EPA's review of, and regulatory action based on, that information, except in· 

accordance with the conditions described inthis Order. 

TESTING 

(a) Section 8(e) Reporting. Reports of information on the PMN substance 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 TSCA section 8(e) shall reference 

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

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

reporting requirements can be found at www.epa.gov/opptitsca8e. 

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

Assistance and Media Programs Divison (2227 A), Office ofEnfo~cement and Compliance 
- 5 -

Assurance, U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., 

Washington, D.C. 20460, of the following information within 10 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: 

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

(2) The name and address of the laboratory which will conduct the study;. 

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

EPA may contact regarding the study; and, 

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

the substance is subject to this Consent Order. 

(c) Good Laboratory Practice Standards and Test Protocols. Each study required perfomled to 

address the risk 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 initiated. Before starting to conduct any 

study that will use a modified version of the published test guidelines, the Company must submit 

written test protocols to EPA for review (submission of written test protocols is options for test 

that are to be conducted using unmodified published test guidelines). Protocols must be 

submitted as a support document for this PMN, using procedures set out in 40 CFR 720. EPA 

will respond to the Company within 4 weeks of receiving the written notice 

(d) Unreasonable Risk. 

EPA may notify the Company in writing that EP A finds that the data generated by.a 
- 6 -

study are scientifically valid and unequivocal and indicate that, despite the terms of this Order, 

the PMN substance will or may present an urueasonable risk of injury to human health or the 

environment. EPA's notice may specify that the Company undertake certain actions concerning 

further testing, manufacture, import, processing, distribution, use and/or disposal of the PMN 

substance to mitigate exposures to or to better characterize the lisks presented by the PMN 

substance. Within 2 weeks from receipt of such a notice, the Company must cease all 

manufacture, import, processing, distribution, use and disposal of the PMN substance, unless 

either: 

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

requirements as EPA's notice specifies; or 

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

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

imposed by EPA. The Company may continue to manufacture, import, process, distribute, use 

and dispose of the PMN substance in accordance with the terms of this Order pending EPA's 

response to the Company's written report. EPA will respond to the Company, in writing, within 

4 weeks of receiving the Company's report. Within 2 weeks of receipt ofEP A's written 

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

all manufacture, import, processing, distribution, use and disposal of the PMN substance, 
- 7 -

PROTECTION IN THE WORKPLACE 

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

substances at any site controlled by the Company (including any associated packaging an.d 

storage and during any cleaning or maintenance of equipment associated with these PMN 

substances), the Company must establish a program whereby: 

(1) General Dermal Protection. Each person who is reasonably likely to be dermally 

exposed in the work area to these PMN substances through direct handling of the substance or 

through contact with equipment on which the substance may exist, is provided with, and is 

required to wear, personal protective equipment that provides a barrier to prevent dermal 

exposure to the substances in the specific work area where it is selected for use. Each such item 

of personal protective equipment must be selected and used in accordance with Occupational 

Safety and Health Administration ("OSHA") dermal protection requirements at 29 CPR 

1910.132,1910.133, and 1910.138. 

(2) Demonstration of Imperviousness. The Company is able to demonstrate that each 

item of chemical protective clothing selected, including gloves, provides an impervious barrier to 

prevent dermal exposure during normal and expected duration and conditions of exposure within 

the work area by anyone or a combination of the following: 

(i) Permeation Testing. Testing the material used to make the chemical 

protective clothing and the construction of the clothing to establish that the protective clothing 

will be impervious for the expected duration and conditions of exposure. The testing must 

. subject the chemical protective clothing to the expected conditions of exposure, including the 

likely combinations of chemical substances to which the' clothing 'may be exposed in the work 
- 8 -

area. Penneation testing shall be conducted according to the American Society for Testing and 

Materials ("ASTM") F739 "Standard Test Method for Resistance of Protective Clothing 

Materials to Penneation by Liquids or. Gases." Results shall be reported as the cumulative 

penneation rate as a function of time, and shall be documented in accordance with ASTM F739 

using the fonnat specified in ASTM F1194-99 "Guide for Documenting the Results of Chemical 

Penneation Testing on Protective Clothing Materials." Gloves may not be used for a time period 

longer than they are actually tested and must be replaced at the end of each work shift during 

which they are exposed to the PMN substance. 

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

manufacturer or supplier ofthe chemical protective clothing, or of the material used in 

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

to the PMN substance alone and in likely combination with other chemical substances in the 

work area. 

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

inhalation in the work area to these PMN substances is provided with, and is required to wear, at 

a minimum, it National Institute for Occupational Safety and Health ("NIOSH")-celiified 

respirator with an Applied Protection Factor ("APF") of I 0,000, from the respirators listed in 

subparagraph (a)(4) ofthis section, and the respirator is used in accordance with OSHA and 

NIOSH respiratory protection requirements at 29 CFR 1910.134 and 42 CFR Part 84. All 

respirators must be issued, used, and maintained according to an appropriate respiratory 

protection program under the OSHA requirements in 29 CFR 1910.134. 
- 9 -

(4) Authorized Respirators. The following NIOSH-certified respirators meet the 

minimum requirements for subparagraph (a)(3) of this section: 

(I) Any NIOSH-certified pressure-demand or other positive pressure 

mode (e.g. open/closed circuit) self-contained breathing apparatus (SCBA) equipped with a hood 

or helmet or full facepiece. 

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

these PMN substances 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 (0.1 percent by weight or volume if 

the PMN substance(s) are identified as a potential carcinogen in paragraph (f) ofthe Hazard 

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

has reason to believe that, during intended activities, these PMN substances in the mixture may 

be reconcentrated above the 1.0 or 0.1 percent level, whichever applies. If this Order contains 

New 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. 
- 10-

NEW CHEMICAL EXPOSURE LIMIT 

(a) Altemative to Requirements of Respirator Section. 

(1) 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 likely to be exposed to these PMN substances by 

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

the Workplace section of this Order, the Company may comply with the requirements oftj1is 

New Chemical Exposure Limit section. However, 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 

these PMN substances, verified in accordance with subsection (c)(3) of this New Chemical 

Exposure Limit section; 

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

Exposure Limit section; and 

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

necessary of the appropriate respiratory protection specified in paragraph (e )(2) of this New 

Chemical Exposure Limit section by persons who are reasonably likely to be exposed to these 

substances by inhalation. 

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

results of actual exposure monitoring conducted in accordance with this New Chemical Exposure 
- 11 -

Limit section, the Company shall not, at that workplace, use the respiratory protection relluired 

in the Protection in the Workplace section of this Order (unless it is the same as required by this 

New Chemical Exposure Limit section). 

(b) Exposure Limit. 

(1) General. The following new chemical exposure limit ("NCEL") for these PMN 

substances is an interim level determined by EP A based on the limited information available to 

the Agency at the time of development of this Order. The NCEL for these substances are as 

follows: 

(i) Time-Weighted Average ("TWA") Limit. The Company shall ensure that no 

person is exposed to an airborne concentration of these PMN substances in excess of 0.32 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 NCEL for that 

work-shift (NCELn) shall be determined b'y the following equation: NCELn = NCEL x (Sin) x 

. [(24-n)1l6], where n = the number of hours in the actual work-shift. 

(2) Automatic Sunset. If, subsequent to the effective date ofthis Order, OSHA 

promulgates, pursuant to §6 of the Occupational Safety and Health Act, 29 U.S.c. 655, a final 

chemical-specific permissible exposure limit ("PEL") specifically applicable to these PMN 

substances and the OSHA 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 

r,~quirements of this New Chemical Exposure Limit section applicable to workers and situations 
- 12 -

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 these PMN 

substances. 

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

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

method for these PMN substances, 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)(B), 

(4)(v)(B), (8), (9), and (l0). Any deviation from the requirements of this subsection (c) must be 

approved in writing by EPA. 

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

submit to EPA a copy of a validated sampling and analytical method for these PMN substances 

which satisfies the criteria specified in this subsection (c). The method description shall 

expressly state how the method compares with each quantitative requirement specified in this 

subsection (c). The submission must include a written statement, signed by authorized officials 

of both the Company and the Laboratory, certifYing the truth and accuracy of the independent 

laboratory verification 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: 

""-N~C=E=L",-",S-",am=p",li",n,.,.gcea""nd"--,-A!oOn",a,"-lyt,-=ic",al=-=M,,,e,,,th""o""d=--:D""o"'-r--"P-"-MN""'-'--'#'--__ ," after which the correct PMN 

numbers for these chemical substances shall be stated. 

(3) Verification of Analytical Method by Independent Third-Party Laboratory. 
- 13 -

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

("Laboratory") velify the validity ofthe analytical method for these PMN substanc.es, in 

accordance with the other requirements in this subsection (c)(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 nO.3(x» £i'om the Company and 

from any other person who may have developed the method for the Company. 

(iii) Accreditation. The Laboratory must be accredited by a formally recognized 

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

(ivy Good Laboratory Practice Standards. The Laboratory verification of the 

. analytical method for these PMN substances must comply with TSCA Good Laboratory Practice 

Standards ("GLPS") at 40 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 ("Test system supply facilities") and 792.90 ("Animal and other test system care"), are 

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

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

verified by a laboratory accredited by either: (A) the American Industdal Hygiene Association 

("AIHA") Industrial Hygiene Laboratory Accreditation Program ("IHLAP"); or (B) another 

comparable program approved in advance in writing by EP A. 

(v) Analysis of Duplicate Samples. The Company shall collect six duplicate 

samples (a total of 12 per PMN)aUheTWA concentration, The samples shall be taken either 
- 14 -

from a conh'olled environment (e.g., a sealed 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. The duplicate 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, the other set of six samples shall 

be analyzed by the Laboratory using the method developed by or for the Company. 

(vi) Sample Storage Study. If the results of the analysis of duplicate samples 

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

Company must perform a sample storage study as follows: 

(1) Triplicate Samples. The Company shall collect six triplicate samples 

(a total of 18 per PMN) 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 low vapor pressure, by injecting 

the PMN substance 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. 

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

perfoffiled with the 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 
- 15 -

conditions must be specified in the method description. 

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

of six samples analyzed by the Laboratory and the Company as required in either paragraph 

(c)(3)(v) or (c)(3)(vi)(II) shall be evaluated using a two-sample t-test with unequal variances, and 

the two sides of the critical regions shall not exceed a 5% significance level. (See Attachment B 

- Statistical Analysis ofNCELs Analytical Method Verification Results.) The arithmetic mean 

of each set of six samples must be within 10% of the overall arithmetic mean of the two sets of 

sample measurements. If the arithmetic mean of each set of six samples is not within 10% of the 

overall arithmetic mean, then the sample storage time between collection and analysis must be 

reduced until the average of each set of six samples is within 10% of the overall arithmetic. mean. 

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

following: 

(i) General. The san1pling and analytical method, and all exposure monitoring 

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

concentrations of these PMN substances ranging from one half the NCEL to twice the NCEL. 

(ii) NCEL QU311titation Limits. The analytical method should be capable of 

reliably qU3l1tifying these PMN substances 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. Ifthe Company obtains an exposure monitoring sample that is more than 

10% above the actual UQL of the analytical method, the Comp3l1Y must comply with paragraph 

",:-, -
- 16 -

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

shall be capable of quantifYing these PMNs to a concentration of one half the NCEL with a 

signal that is at least five times the baseline noise leyel. Baseline noise must be amplified to a 

measurable level when possible, even ifthe required amplification is beyond that used in routine 

analysis of samples. (If baseline noise cannot be obtained, another reference must be selected. 

This may be a peak considered to be noise caused by the reagent matrix.) The sampling 

preparation method must be specified and the detection limit for the analytical procedure must be 

,reported as mass per injection for chromatographic techniques. 

(iv) Instrument Calibration. 

(I) Initial Calibration. 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 of 0.95 -- these five (5) calibration standards must 

consist of one standard at each of the following concentrations: one half the NCEL (0.5 x 

NCEL); between one half and one times the NCEL(0.5 x NCEL < > 1 x NCEL); one times the 

NCEL (1 x NCEL); between one and two times the NCEL (1 x NCEL < > 2 x NCEL), and twice 

the NCEL (2 x NCEL): 

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

development/validation 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 sample at the NCEL concentration, and at least one additional 

calibration sample per every 10 samples analyzed. The continuing calibration sample shall fall 

within ± 25% of the initial calibration value. Ifnot, then the initial calibration must be Tepeated,;, 
- 17 -

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

(v) Calculated Percent Recovery. 

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

Company must calculate the percent of the PMN substance recovered by the analytical method 

from a sample containing a known quantity of these PMN substances. The sample 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 low vapor 

pressure, by injecting the PMN substance onto a sample collection device. (Such a sample is 

referred to as a "matrix spike"). The calculated percent recovery for each matrix spike shall be 

greater than or equal to 75% and less than or equal to 125%. Spike concentrations for the PMN 

substance must be included in the sampling and analytical method submitted to EPA. 

(II) . Subsequent Calculation. During each subsequent exposure 

monitoring episode or campaign, at least I matrix spike, prepared by injecting these PMN 

substances onto a sample collection device, shall be analyzed. (This matrix spike must be 

prepared at the NCEL concentration.) 

(vi) Sampling Device Capacity. 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 minimal 

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 breakthrough testing. This testing must be done at a concentration twice 

the NCEL and under conditions .similar to thosee,xpected in the workplace. Breakthrough is .:' . 
- 18 -

defined to have occurred when the concentration of these PMN substances in the effluent stream 

is equal to S% 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 

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

with the PMN substance at least the NCEL concenh'ation must be prepared. A recovery of at 

least 7S% must be obtained for each of the six samples. 

(S) Precision. The estimate of the coefficient of variation of each set of six samples from 

the controlled atmosphere test (spiked at 1.0 NCEL, per paragraphs (c)(3)(v) or (vi» must be less 

than 0.1 OS, including allowance of O.OS for error due to sampling. 

(6) Interpretation of Accuracy and Precision Data . 

. (i) If a single matrix spike recovery is less than 75% recovery or greater than 

125% or the estimated precision is greater than 0.105, then the Company must Te-prepare the 

matrix 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 7S%, correction for low 

recovery is reql,lired. Correct for recovery fiTst by dividing the observed amount by the 

proportion recovered before determining if measurements fall below the NCEL. For example, if 

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

40 mg/m3 when determining whether the levels are below the exposure limit. 

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

.)1llmic the actual workplace environment expected to be monitored .. Conditions such as the 
- 19 -

temperature, humidity, lighting, and presence of other chemicals, etc. must mimic the conditions 

in the workplace to be monitored. 

(8) Changes Affecting Validity. lfthe workplace 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. Examples of possible changes include but are not limited to: introduction 

of a new chemical substance(s) to the workplace which may interfere with the analysis of these 

new chemicals; introduction of light to the workplace which may interfere with a light-sensitive 

PMN substance(s); or introduction of water/increased humidity to the workplace which could react 

with the PMN substance(s) 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. 

(10) Responsibility for Method Validity. The independent laboratory verification and EPA 

receipt of the sampling and anal yticalmethod 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) Monitoring Potential Exposure. 

(l) General. 

(i) Action Level. . The "action level" is defined as an airborne concelltrationofthe 
- 20-

PMN substance(s), calculated as an 8-hour time-weighted average, equal to one half the NCEL 

TWA specified in subparagraph (b )(1). For non-8-hout work shifts, the action level is equal to one 

half the NCELn. (The NCELn is described in subparagraph (b)(l)(ii).) The Company may exceed 

the action level without penalty. The purpose of the action level is solely to detennine the 

requisite monitoring frequency. 

(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 substance(s) would be if respirators were not worn. The Company 

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

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

operations in each work shift, in each job classification, in each work area (hereinafter identified as 

an "exposure group") where inhalation exposure to these PMN substances are 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 anotller person in fue same exposure group. 

(iii) Good Laboratory Practice Standards. Detenninations of potential inhalation 

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, such as 40 CPR 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 the NCEL requirements.} However, compliance with TSCA GLPS is not required·. 
- 21 -

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

American Industrial Hygiene Association ("AIHA") Industrial Hygiene Laboratory Accreditation 

Program ("IHLAP"); or (B) another comparable program approved in advance in writing by EPA. 

(iv) Full Shift Exposure Samples. Representative 8-hour TWA airborne 

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

each exposure group. 

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

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

to accurately determine the airborne concentration of these PMN substances for each exposure 

group in which persons are reasonably likely to be exposed to these PMN substances. 

(3) Periodic Monitoring. 

(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 these PMN 

substances are not manufactured, processed, or used .at all during a given 6 month calendar period, 

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

of these PMN substances are resumed. However, cessation of manufacturing, processing and use 

of these PMN substances for less than the 6 month period does not constitute grounds for 

postponement of the 6 month deadline to conduct 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. If thesePMN substances are not 
- 22-

manufactured, processed, or used at all during a given 3 month calendar period, the Company is 

not required to conduct exposure monitoring until manufacture, processing, or use of these PMN 

substances is resumed. However, cessation of manufacturing, processing and use of these PMN 

substances 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 least 7 days apart indicate that the potential exposure has decreased to the TWA or below, but is 

at or' above the action level. Where these PMN substances are 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 

variability in exposure. 

(4) Termination of MonitOling. 

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

airbome 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. 

(ii) Ifrepresentative samples taken during the periodic monitoring reveal that an 

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

apart, are 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 

ExposureLimitsection. Where these PMN substances are manufactured;.processed, or.used in 
- 23 -

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 

variability 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)(5)(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: 

(I) change in the production volume, process, control equipment, personnel 

or work practices that may reasonably cause new or additional exposures to these PMN 

substances; 

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

cause new or additional exposures to these PMN substances; and, 

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

may reasonably result in new or additional exposures to these PMN substances. 

(ii) In no event is the additional exposure monitoring requirement in paragraph 

(d)(5)(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 use at least the respiratory 

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

respiratory equipment deem?c! appropriateby the best professional judgment of a qualified.expeq. 
- 24-

(6) Notification of 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 notified 

in writing either individually or by posting the infonnation in an appropriate and accessible 

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 sha.ll refer to a document available to the person which states 

the actions to be taken to reduce exposure. 

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

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

these PMN substances will not exceed the action level (defined in paragraph (d)(J)(i)) under the 

expected handling procedures and conditions for a specific "exposure group" (defined in paragraph 

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

(except paragraph(d)(5) "Additional Monitoring" and subsection(f) "NCEL Recordkeeping") 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 these PMN substances 

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

methods, work practices, and environmental conditions in the Company's current workplace 

operations with the PMN substances. Examples of objective data that may be used to demonstrate 
- 25 -

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

infonnation on the physical and chemical properties of the PMN substances, industry-wide studies, 

and/or laboratory test results. 

(e) Respiratory Protection. 

(1) 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 thee PMN substances for any person who is reasonably likely to be 

exposed to these PMN substances by inhalation exceeds the NCEL,the Company shall provide 

those persons the respirators specified in this subsection (e) (rather than the respirator(s) identified 

in the Protection in the Workplace section ofthis Order), and shall ensure that the respirators are 

used (including training, fit testing, and maintenance) in accordance with OSHA and NIOSH 

respiratory protection requirements at 29 CPR 1910.134 and 42 CPR Part 84. When the Company 

has not yet measured the airborne concentration of the PMN substances 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) Selection 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 likely to be 

exposed to these PMN substances by inhalation use, at a minimum, the respiratory protection 

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

... motective respirator which corresponds to a concentrationhight;J;than measured). 
Measured 

Concentration 

of PMN Substance 

::: NCEL 

< 10 x NCEL 

::: 25 x NCEL 

- 16-

GASIV APOR RESPIRATOR TABLE 

Required Respiratory Protection 

No respiratory protection is required. 

If Data on Cartridge Service Lite Testing has been Reviewed and Approved 

bvEPA: 

(I) Any NIOSH-certified powered air-purifying respirator with a hood or 

helmet equipped with appropriate gas/vapor (acid gas, organic vapor, or 

substance specific) cartridges. 

(II) Any NIOSH-certified continuous flow supplied-air respirator equipped 

with a loose fitting facepiece, hood, or helmet. 

If No Cartridge Service Lite Testing has been Conducted: 

(I) Any NIOSH-certified continuous flow supplied-air respirator equipped 

with a loose fitting facepiece, hood, or helmet. 

If Data on Cartridge Service Life Testing has been Reviewed and Approved 

by EPA: 

(I) Any NIOSH-certified powered air-purifying respirator with a hood or 

helmet equipped with appropriate gas/vapor (acid gas, organic vapor, or 

substance specific) cartridges. 

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

loose fitting facepiece with appropriate gas/vapor (acid gas, organic vapor, 

or substance specific) cartridges. 

(III) Any NIOSH-certified continuous flow supplied-air respirator equipped 

with a hood or helmet. 

(IV) Any NIOSH-certified continuous flow supplied-air respirator 

equipped with a loose fitting facepiece. 
::: 50 x NCEL 

< 1000 x NCEL 

lfNo Cartridge Service Life Testing has been Conducted: 

(I) Any NIOSH-certified continuous flow supplied-air respirator equipped 

with a loose fitting facepiece, hood, or helmet. 

(II) Any NIOSH-certified negative pressure (demand) supplied-air 

respirator equipped with a full facepiece. 

If Data on Cartridge Service Life Testing has been Reviewed and Approved 

by EPA: 

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

with appropriate gas/vapor cartridges or canisters (acid gas, organic vapor, 

or substance specific). 

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

tight-fitting facepiece (half or full facepiece) and appropliate gas/vapor 

eartridges or canisters (acid gas, organic vapor, or substance specific). 

(III) Any NIOSH-certified negative pressure (demand) supplied-air 

respirator equipped with a full facepiece. 

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

breathiug apparatus (SCBA) equipped with a hood, helmet, or a full 

facepiece. 

lfNo Cartridge Service Life Testing has been Conducted: 

(I) Any NIOSH-certified negative pressure (demand) supplied-air respirator 

equipped with a full facepiece, 

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

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

facepiece. 

If Data on Cartridge Service Life Testing has been Reviewed and Approved 

by EPA: . 

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

equipped with appropriate gas/vapor (acid gas, organic vapor, or substance 

specific) cartJidges. 
> 1000 x NCEL 

(max. 10,000 x 

NCEL) 

- 28 -

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

hood or helmet and appropriate gas/vapor (acid gas, organic vapor, or 

substance specific) cartridges with evidence demonstrating protection level 

of ], 000 or greater. 

(III) Any NlOSH-certified continuous flow supplied-air respirator equipped 

with a full facepiece. 

(IV) Any NlOSH-certified continuous flow supplied-air respirator 

equipped with a hood or helmet with evidence demonstrating protection 

level of I, 000 or greater. * 

(VI) Any NlOSH-certified pressure-demand or other positive pressure mode 

supplied-air respirator equipped with a full facepiece. 

If No Cartridge Service Life Testing has been Conducted: 

(I) Any NIOSH-certified continuous flow supplied-airrespirator equipped 

with a full facepiece. 

(II) Any NIOSH-certified continuous flow supplied-air respirator equipped 

with a hood or helmet with evidence demonstrating protection level of 1, 000 

or greater. 

(III) Any NlOSH-certified pressure-demand or other positive pressure mode 

supplied-air respirator equipped with a full facepiece; 

Any NlOSH-certified pressure-demand or other positive pressure mode 

(e.g., open/closed circuit) self-contained breathing apparatus (SCBA) 

equipped with a hood or helmet or a full facepiece. 

* OSHA has assigned APFs of 1000 for certain types of hoods and helmets with powered 

air purifying respirators (PAPRs) or supplied air respirators (SARs) where the manufacturer 

can demonstrate adequate air flows to maintain positive pressure inside the hood or helmet 

in normal working conditions. However, the employer musfhave evidence provided by the 

respirator manufacturer that the testing of these respirators demonstrates performance at a 

level of protection of! ,000 or greater to receive an APF of!,OOO. This level of 

perfollllance can best be demonstrated by performing a Workplace Protection Factor (WPF) 

or Simulated Workplace Protection Factor (SWPF) study or equivalent testing. Without 

testing data that demonstrates a level of protection of 1,000 or greater, all PAPRs and 

SARs with helmets/hoods are to be treated as loose-fitting facepiece respirators, and 

receive an APF of 25. 
- 29-

(3) Reductions in Respiratory Protection. After appropriate respiratory protection has 

been selected based on the results of actual exposure monitoring conducted at a workplace in 

accordance with subsection (d) of this New Chemical 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 (e)(2). Where these PMN substances are 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 variability in exposure. 

(4) Special Situations. 

(i) Measurements Outside Ommtitation Limits. When a value less than the lower 

quantitation limit ("LQL") of the analytical method (as described in paragraph (c)(4)(ii)) is 

measured, the Company shall estimate potential exposure using generally established and accepted 

statistical methods. If the Company obtains an exposure monitoring sample that is more than 10% 

above the actual upper quantitation limit ("UQL") of the analytical method, the Company must 

ensure that its workers wear at least a NIOSH-certified supplied-air respirator operated in pressure 

demand or other positive pressure mode and equipped with a tight-fitting full facepiece. Any 

reductions in this respiratory protection must comply with paragraph (e)01) .. The Company may 
- 30-

submit an improved analytical method provided that it complies fully with subsection (c) of this 

New Chemical Exposure Limit section, including the velification 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 ( e) for the measured airborne 

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

professional judgment of a qualified expert. 

(f) NCEL Recordkeeping. 

(I) Whenever the Company elects to comply with this New Chemical Exposure Limit 

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 are 

created, and shall make them available for inspection and copying by EP A in accordance with 

.section 11 ofTSCA: 

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

their accuracy over time as required by section ( c); 

(ii) Records documenting compliance with the analytical method verification 

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

verification results obtained by both laboratories; 

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

Standards at 40 CPR Part 7Q2, or use of a laboratory accredited by the AIHA or another 
- 31 -

comparable program approved in advance in writing by EPA. Where the Company elects to not 

comply with TSCA GLPS, such records shall include the wlitten accreditation from the AIHA or 

the written approval from EPA. 

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

each sample taken; 

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

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

intel),ded 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 exposures to 

these PMN substances; 

(ix) Records documenting any spills, leaks, ruptures or other breakdowns that may 

cause new or additional exposure; 

substances; 

(x) The type of respiratory protective devices worn by the monitored person, if any; 

(xi) Records documenting any actions taken to mitigate exposures to these PMN 

(xii) Records documenting reliance on the objective 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 
- 32-

employee exposures covered by the exemption. 

HAZARD COMMUNICATION PROGRAM 

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

written hazard communication program for these PMN substances in each workplace. The written 

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

other forms ofwaming 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 established under the OSHA Hazard Communication 

Standard (29 CPR 1910.1200), to comply with this paragraph provided that the existing hazard 

communication program satisfies the requirements ofthis section. The written program shall 

include the following: 

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

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

40 C.P.R. Part 721, subpart E. The list must be maintained in each work area where these PMN 

substances are known to be present and must use the identity provided on the MSDS for the 

substance required under paragraph (c) ofthis section. The list may be compiled for the workplace· 

or for individual work areas. If the Company is required either by another Order issued under 

section 5(e) ofTSCA, or by a TSCA section 5(a)(2) SNUR at 40 CPR Part 721, subpart 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 onhe hazards of non-routine 
- 33 -

tasks involving these PMN substances (e.g., cleaning of reactor vessels), and the hazaxds 

associated with these PMN substances contained in unlabeled pipes in their work axea. 

(3) The methods the Company will use to infom1 contractors of the presence of these PMN 

substances in the Company's workplace and ofthe provisions of this Order if employees of the 

contractor work in the Company's workplace and axe reasonably likely to be exposed to these 

PMN substances while in the Company's workplace. 

(b) Labeling. 

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

labeled in accordance with this subparagxaph (b)(1). 

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

(I) A statement of the health hazaxds(s) and precautionarymeasure(s), if 

any, identified in paxagxaph (1) of this section or by the Company, for these PMN substances. 

(II) The identity by which each PMN substance may be commonly 

. recognized. 

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

measure(s), if any, identified in paxagraph (1) of this section, or by the Company, for these PMN 

substances. 

(IV) A statement of exposure and precautionary measure(s), if any, 

identified in paragxaph (1) of this section, or by the Company, for these PMN substances. 

(ii) The Company may use signs, placaxds, process sheets, batch tickets, operating 

procedures, or oth~r\such written materials in lieu of affixing labels to individual stati?naxy process 
- 34 -

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

conveys information specified by subparagraph (b) (1 lei) of this section. Any written materials 

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

(iii) The Company need not label portable containers into which these PMN 

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

use of the employee who performs the transfer. 

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

these PMN substances obtained from persons outside the Company unless the container is 

immediately re-labeled with the information specified in subparagraph (b)(I)(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 following information: 

(1) The information prescribed in subparagraph (b )(1 lei) of this section. 

(II) The name and address of the manufacturer or a responsible party who 

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

emergency procedures. 

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

Transportation Act (18 U.S.c. 1801 et. seq.) and regulations issued under that Act by the 

Department of Transportation. 

(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 English; however, the 

information may be repeated in other languages. 
- 35 -

(5) If the label or alternative form ofwamingis to be applied to a mixture containing these 

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

section 5(e) Order applicable to the Company, or subject to a TSCA section 5(a)(2) SNUR at 40 

CPR Part 721, subpart E, or defined as a "hazardous chemical" under the OSHA Hazard 

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

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

which the Company determines provide the greatest degree of protection. However, should these 

control measures differ fi·om the applicable nleasures required Ullder this Order, the Company must 

seek a determination of equivalency for such altemative control measures pursuant to 40 CPR 

721.30 before prescribing them under this subparagraph (b )(5). 

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

hazards of these PMN substances or ways to protect against the hazards, this new infomlation must 

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

information. If these PMN substances are not being manufactured, imported, processed, or used in 

the Company's workplace, the Company must add the new infoTInation to the label before these 

PMN substances is reintroduced into the workplace. 

(c) Material Safety Data Sheets. 

(1) The Company must obtain or develop an MSDS for these PMN substances. 

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

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

section, and, if not claimed confidential, the chemical and common name of these PMN 
- 36-

substances. lfthe chemical and common name is claimed confidential, a generic chemical name 

must be used. 

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

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

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

potential for fire, explosion, and reactivity. 

(iv) The potential human and environmental hazards as specified in paragraph (f) 

of this section. 

(v) Signs and symptoms of exposure, and any medical conditions which are 

expected to be aggravated by exposure to these PMN substances known to the Company. 

(vi) The primary routes of exposure to these PMN substances. 

(vii) Precautionary measures to control worker exposure andlor environmental 

release required by this Order, or alternative control measures which EPA has deternlined under 40 

CFR 721.30 provide substantially the same degree of protection as the identified control measures. 

The MSDS must identify any New Chemical Exposure Limits specified in paragraph (b) of the 

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

the graduated respirator table in paragraph (e)(2) ofthe New Chemical Exposme Limit section. 

(viii) Any generally applicable precautions for safe handling and use of these PMN 

substances which are known to the Company, including appropriate hygienic practices, protective 

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

to spills and leaks. 

(ix) Any generally applicable control measures which are \alown to the Company, 
- 37-

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

(x) Emergency 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) Ifno 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 these PMN substances have similar compositions 

(i.e., the chemical ingredients are essentially the same, but the specific composition varies from 

mixture to mixture) and similar hazards, the Company may prepare one MSDS to apply to all of 

these multiple mixtures. 

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

hazards of these PMN substances 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 ofthe new 

information. If these PMN substances are not being manufactured, imported, processed, or used in 

the Company' Ii workplace, the Company must add the new information to the MSDS before these 

PMN substances are reintroduced into the workplace. 

(6) The Company must ensure that persons receiving these PMN substances from the 

Company are provided an appropliate 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. 
- 38 -

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

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

(8) The MSDS may be kept in any form, including as operating procedures, and may be 

designed to cover groups of substances in a work area where it may be more appropriate to address 

the potential hazards of a process rather than individual substances. However, in all cases, the 

required information must be provided for these PMN substances 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) Employee Information and Training. The Company must ensure that employees are provided 

with information and training on these PMN substances. This information and training must be 

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

substances and whenever the PMN substances are introduced il1to the employee's work area for 

the first time. 

(1) The infOlmation provided to employees under this paragraph shall include: 

(i) The requirements ofthis section. 

(ii) Any operations in the work area where the PMN substances are present. 

(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 (a) (1 ) of this section and MSDSs required by paragraph (c) of this section. 

(2) The training provided to employe~s.shall include: 
- 39 -

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

these PMN substances in or from an employee's work area (such as exposure monitoring 

conducted by the Company, continuous monitoring devices, visual appearance, or odor of the 

substance when being released). 

(ii) The potential human health and environmental hazards of these PMN 

substances as specified in paragraph (f) of this section. 

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

from these PMN substances, including specific procedures the Company has implemented to 

protect employees and the enviromnent from exposure to these PMN substances, including 

appropriate work practices, emergency procedures, personal protective equipment, engineering 

controls, and other measures to control worker exposure and/or environmental release required 

under this Order, or alternative cont·ol measures which EPA has determined under 40 CFR 721.30 

provide the same degree of protection as the specified 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. 

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

these PMN substances 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 (0.1 percent by weight or volume if 

the PMN substance(s) are identified as a potential carcinogen in paragraph (f) ofthe Hazard 

Communication Program section of this Order). This exemption.is not available if the Company 
- 40-

has reason to believe that, during intended activities, these PMN substances in the mixture may be 

reconcentrated above \he 1.0 or 0.1 percent level, whichever applies. If this Order contains New 

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

NCEL concentration ("TWA") or in-stream concentration ("N") less \han the de minimis 

concentration specified here, \hen this de minimis exemption does not apply to \hose provisions. 

(f) Human Health, Exposure, and Precautionary Statements. The following human heal\h and 

environmental hazard and precautionary statements shall appear on each label as specified in 

paragraph (b) and the MSDS as specified in paragraph (c) of \his section: 

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

(i) skin irritation. 

(ii) respiratory complications. 

(iii) central nervous system effects. 

(iv) internal organ effects. 

(v) birth defects . 

. (vi) reproductive effects. 

(vii) cancer. 

(viii) immune system effects. 

(ix) developmental effects. 

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

(i) avoid skin contact. 

(ii)'avoid breathing the substance. 
- 41 -

(iii) avoid ingestion. 

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

below an 8-hour time-weighted average of 0.32 mg/m3

. 

v) use skin protection. 

(3) Environmental hazard statements. This substance may be: 

(i) toxic to fish. 

(ii) toxic to aquatic organisms. 

(4) Environmental hazard precautionary statements. Notice to users: 

(i) disposal restrictions apply. 

(ii) spill clean-up restrictions apply. 

(iii) do not release to water. 

(5) The human and environmental hazard and precautionary statement on the label 

prepared pursuant to paragraph (b) of this section must be followed by the statement: "See 

the MSDS for details." 

(g) Existing Hazard Communication Program. The Company need not take additional actions if 

existing programs and procedures satisfy the requirements of this section. 
- 42-

MANUFACTURING 

(I) Prohibition. The Company shall not cause, encourage, or suggest the manufaGture or 

import of these PMN substances by any other person. 

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

of a final significant new use rule ("SNUR") governing these PMN substances 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) Notice of SNUR. When EPA promulgates a final SNUR for these PMN substances 

and subparagraph (a)(I) expires in accordance with subparagraph (a)(2), the Company shall notify 

each person whom it causes, encourages or suggests to manufacture or import these PMN 

substances of the existence of the SNUR. 

DISTRIBUTION 

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

writing any person to whom it distributes these PMN substances that, due to the issuance of this 

Consent Order under. section 5(e) of TSCA, these PMN substances are subject to the export 

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

shall contain, in the fonn in which it appears in this Consent Order, the following information: (1) 

the PMN number(s), and (2) either (A) the specific chemical identity of the PMN substance(s), or 

(B) ifthe specific chemical identity is confidential, the generic chemical identity 
- 43 -

(b) Distribution Reguirements. The Company shall distribute these PMN substances outside the 

Company, other than for disposal only to a person who has agreed in writing prior to the date of 

distribution to: 

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

the issuance of this Consent Order under section See) ofTSCA, these PMN substances are subject 

to the export notification requirements ofTSCA section 12(b) and 40 CFR Part 707 SubpaJ.i D. 

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

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

substance(s), or (B) if the specific chemical identity is confidential, the generic chemical identity. 

(2) Comply with the same requirements and restrictions, if any, required of the Company 

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

(3) Comply with the same requirements and restrictions, if any, required of the Company 

in the Hazard Communication Program section of this Order. 

(4) Comply with the same environmental release restriction, if any, required of the 

Company in the Release to Water section of this order. 

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

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

sealed containers (labeled in accordance with paragraph (b )(2) of the Hazard Communication 

Program section of this Order) provided the following two conditions are met: 

(1) Subsequent to any such exempt temporary transport or storage of sealed containers, 

these PMN substances may be distributed only to the Company or a perso,n.,who has given the 
-44 -

Company the written agreement required by paragraph (b). 

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

washing out these PMN substances may occur only while these PMN substances are in the 

possession and control of the Company or a person who has given the Company the written 

agreement required by paragraph (b). 

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

these PMN substances, the Company obtains knowledge that a recipient of the substance has failed 

to coinply with any of the conditions specified in paragraph (b) of this Distribution section or has 

eengaged in a significant new use of these PMN substances (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: 

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

recipient 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 these PMN substances 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 that the recipient is 

aware of the terms of paragraph (b) ofthis Distribution section and will comply with tllose terms, 

or is aware of the terms of the significant new use rule for these PMN substances and will not 

engage in a significant new use without submitting a significant new use notice to EPA. 
- 45 -

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

of this Distribution section, the Company obtains knowledge that the recipient has failed to comply 

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

a significant new use of these PMN substances without submitting a significant new use notice to 

EPA, the Company shall cease supplying these PMN substances to that recipient, shall notify EPA 

of the failure to comply, and shall resume supplying these PMN substances to that recipient only 

upon written notification from the Agency. 

(e) Sunset Following SNUR. (1) Paragraph (b)(2) of this Distribution section shall expire 75 

days after promulgation of a final SNUR for these PMN substances under section 5(a)(2) of 

TSCA, 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, paragraph (b )(2) ofthis 

Distribution section shall not expire until EPA notifies the Company in writing that all Federal 

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

(2) When EPA promulgates a final SNUR for thesePMN substances and paragraph (b )(2) of this 

Distribution section expires in accordance with subparagraph (e)(1), the Company shall notify each 

person to whom it distributes these PMN substances of the existence of the SNUR. Such' 

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

which are defined as significant new uses, and which would invoke significant new use 

notification to EPA for these PMN substances. Such notice must also reference the publication of 

the SNUR for these PMN substances in either the Federal Register or the Code of Federal 

Regulations. After promulgation of a SNUR:and expiration of subparagraph (b )(2), such notice 
- 46-

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 these PMN 

substances, then the Company is not required to obtain from such persons the written agreement 

specified in paragraph (b). 

RELEASE TO WATER 

This provision does not supersede or preempt any applicable federal, state, and local laws and 

regulations. (Those other laws may be more stringent than the requirements below.) The 

Company is prohibited from any predictable or purposeful release of these PMN substances, or any 

waste stream from manufacturing, processing or use containing the PMN substance: 

(I)(a) Into the waters of the United States if the quotient from the formula: 

number of kilograms/day/site released 

-------------.----------------------------------- x 1000 = N parts per billion 

receiving ~;tream flow (million liters/day) 

exceeds 5 ppb for PIl-327, Pll-328, Pll-329, Pll-330, Pll-331, and PIl-332 when calculated 

using the methods described in 40 CFR 721.91. 

(b) In lieu of calculating the quotient in subparagraph (4)(a), monitoring or alternative 

calculations may be used to predict the surface water concentration expected to result from the 

intended release of the substance, ifthe monitoring procedures or calculations have been approved 

for such purpose by EPA. EPA will review and act on a written request to approve monitoring 

procedures or alternative calculations within 90 days after such a request is received. The Agency 
- 47 -

will inform the Company of the disposition of such requests in writing and, where a request is 

denied, will explain the reasons therefore. 

III. RECORD KEEPING 

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

are created and shall make them available for inspection and copying by EPA in accordance with 

section 11 ofTSCA: 

(1) Exemptions. Records documenting that any ofthese PMN substances did in fact 

qualify for anyone or more of the exemptions described in Section I, Paragraph (b) of this Order. 

Such records must satisfy all the statutory and regulatory recordkeeping requirements applicable to 

the exemption being claimed by the Company. Any amounts or batches of these PMN substances 

eligible for the Export exemption in Section I, Paragraph (b)(1) of this Order are exempt from all 

the requirements in this Recordkeeping 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 12(a)(I)(B) and 12(b), respectively. Any amounts or batches of these PMN substances 

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

are exempt from all the requirements in this Recordkeeping section, if the 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 these PMN substances claimed to be eligible for any other exemption 

described in Section I, Paragraph (b) of this Order, the Company shall keep records demonstrating 

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

but is exempt fi'omthe other recordkeeping requirements in this Recordkeeping section; 
- 48 -

(2) Records documenting the manufacture and impOliation volume of each PMN substance 

and the corresponding dates of mannfacture and import; 

(3) Records documenting the names and addresses (including shipment destination 

address, if different) of all persons outside the site of manufacture or import to whom the Company 

directly sells or transfers these PMN substances, 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, 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 documenting the detenninations required by the Protection in the Workplace 

section of this Order that chemical protective clothing is impervious to these PMN substances; 

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

this Order, if applicable; 

(8) Records required by the release to water section of this Order. 

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

program required by the Hazard Communication Program section of this Order; 

(10) Copies oflabe1s required under the Hazard Communication Program section of this 

Order; 

(11) Copies of Material Safety Data Sheets required by the Hazard Communication 

Program section ofthis Order; 
- 49-

(12) Records documenting compliance with any applicable manufacturing, processing, 

use, and distribution restrictions in the Manufacturing and Distribution sections of this Order, 

including distributees' written agreement to comply with the Distribution section of this Order; 

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

section of this Order, if applicable; and 

(14) The Company shall keep a copy of this Order at each of its sites where these PMN 

substances are manufactured or imported. 

(b) Applicability. The provisions of this Recordkeeping Section are applicable only to activities 

of the Company and its Contract Manufacturer, if applicable, and not to activities of the 

Company's customers. 

(c) OMB Control Number. Under the Paperwork Reduction Act and its regulations at 5 CFR Part 

1320, particularly 5 CFR 1320.5(b), the Company is not required to respond to this "collection of 

information" unless this Order displays a cUlTently valid control number from the Office of 

Management and Budget ("OMB"), and EPA so informs the Company. The "collection of 

information" required in this TSCA §5(e) Consent Order has been approved under cUlTently valid 

OMB Control Number 2070-0012. 
- 50-

IV. REQUESTS FQRPRE-INSPECTION INFORMATION 

(a) EPA's Request for Infomlation. Pursuant to section 11 ofTSCA and 40 CFR 720.122, EPA 

may occasionally conduct on-site compliance inspections of Company facilities and conveyances 

associated with these PMN substances. To facilitate such inspections, EPA persoffi1el may contact 

the Company in advance to request information pertinent to the scheduling and conduct of such 

inspections. Such requests may be written or oral. The types of information that EPA may request 

include, but are not limited to, the following: 

(I) Expected dates and times when these PMN substances will be in production within the 

subsequent 12 months; 

(2) Current workshift schedules for workers who are involved in activities associated with 

these PMN substances and may reasonably be exposed to these PMN substances; 

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

with these PMN substances and may reasonably be exposed to these PMN substances; 

(4) Existing exposure monitoring data for workers who are involved in activities 

associated with the PMN substance(s) and may reasonably be exposed to these PMN substances; 

(5) Records required by the Recordkeeping section of this Order; and! or 

(6) Any other infonnation reasonably related to determining compliance with this Order or 

conducting an inspection for that purpose. 

(b) Company's Response. The Company shall respond to such requests within a reasonable 

period of time, but in no event later than 30 days after receiving EPA's reqllest. Whenreqllested 
• 

- 51 -

in writing by EPA, the Company's response shall be in writing. To the extent the information is 

known to or reasonably ascertainable to the Company at the time of the request, the Company's 

response shall demonstrate a good faith effort to provide reasonably accurate and detailed answers 

to all of EPA's requests. 

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

Company submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of 

TSCA and 40 CPR Part 2. 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

(a) Scope. This section sets forth the procedures by which the Company's rights and obligations 

under this Order may be transferred when the Company transfers its interests in these PMN 

substances, including the right to manufacture these PMN substances, to another person outside the 

Company (the "Successor in Interest") . 

(b) Relation of Transfer Date to Notice of Commencement ("NOC"). 

(1) Before NOC. If the transfer from the Company to the Successor in Interest is effective 

before EPA receives a notice of commencement of manufacture or import ("NOC") for these PMN 

substances from the Company pursuant to 40 CFR 720.102, the Successor in Interest must submit 

a new PMN for each substance to EPA and comply fully with Section 5(a)(1) ofTSCA and 40 

CPR part 720 before commencing manufacture or import of these PMN substances. 

(2) After NOC .. Ifthe transfer from the Company to the Successor in Interest. is.effeRtivl;) 
- 52 _. 

after EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and 

shall not be required to submit a new PMN to EPA. 

(c) Definitions. The following definitions apply to this Successor 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 any of these PMN substances, including all 

ownership rights and legal liabilities, through 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 these PMN substances, such as a licensee who has 

acquired a limited license to the patent or manufactUllng rights associated with these PMN 

substances. A Successor in Interest must be incorporated, licensed, or doing business in the United 

States in .accordance with 40 CFR n0.22(a)(3). 

(2) "Transfer Document" means the legal instrUlnent(s) used to convey the interests in 

these PMN substances, including the right to manufacture these PMN substances, from the 

Company to the Successor in Interest. 

(d) Notices. 

(1) Notice to Successor in Interest. On or before the effective date of the transfer, the 

Company shall provide to the Successor in Interest, by registered mail, a copy of the Consent 

Order and the "Notice of Transfer" document which is incorporated by reference as Attachment C 

to this Order. 

(2) Notice to EPA. Within. 10 business daysoftheeffective date ofthe transfer, the 
- 53 -

Company shall, by registered mail, submit the fully executed Notice of Transfer document to: 

U.S. Environmental Protection Agency, New Chemicals Branch (7405), 1200 Pellrlsylvania 

Avenue, N.W., Washington, D.C. 20460. 

(3) Transfer Document. Copies of the Transfer Document must be maintained by the 

Successor in Interest at its principal place of business, and at all sites where these PMN substances 

are manufactured or imported. Copies of the Transfer Document must also be made available for 

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must 

contain provisions which expressly transfer liability for these PMN substances under the terms of 

this Order from the Company to the Successor in Interest. 

(e) Liability. 

(1) The Company shall be liable for compliance with the requirements of this Order until 

the effective date of the transfer described above. 

(2) The Successor in Interest shall be liable for compliance with the requirements of this 

Order effective as of the date of transfer. 

(3) Nothing in this section shall be construed to prohibit the Agency from taking 

enforcement action against the Company after the effective date of the transfer for actions taken, or 

omissions made; during the time in which the Company manufactured, processed, used, or 

distributed in commerce of these PMN substances pursuant to the terms of this Consent Order. 
- 54-

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new information on the health 

effects of, or human exposure to, these PMN substances, to modify or revoke substantive 

provisions of this Order. The exposures and risks identified by EP A during its review of these 

PMN substances and the information EPA determined to be necessary to evaluate those exposures 

and risks are described in the preamble to this Order. However, in determining whether to amend 

or revoke this Order, EPA will consider all relevant infonnation available at the time the Agency 

makes that determination, including, where appropriate, any reassessment of the test data or other 

information that supports the findings in this Order, an examination of new test data or other 

information or analysis, and any other relevant information. 

EPA will issue a modification or revocation if EPA determines that the activities proposed 

therein will not present an unreasonable risk of injury to health or the environment and will not 

result in significant or substantial hmnan exposure or substantial enviromnental release in the 

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

these PMN substances. 

In addition, the Company may petition EPA at anytime to make other modifications to the 

language of this Order. EPA will issue such a modification if EPA determines that the 

modification is useful, appropriate, and consistent with the structure and intent ofthis Order as 

issued. 
- 55 -

VII. EFFECT OF CONSENT ORDER 

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

objections to this Order pursuant to section 5(e)(1)(C) ofTSCA, to receive service of this Order no 

later than 45 days before the end of the review period pursuant to section 5(e)(1)(B) ofTSCA, and 

to challenge the validity of this Order in any subsequent action. Consenting to the entry of this 

Order, and agreeing to be bound by its terms, do not constitute an admission by the Company as to 

the facts or conclusions underlying the Agency's detem1inations in this proceeding. This waiver 

does not affect any other rights that the Company may have under TSCA. 

(b) CBI 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 CFR Part 720 Subpart E, and 40 CFR Part 2) is correctly 

identified within brackets and that any infonnation that is not bracketed is not claimed as 

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

infonnation contained within the brackets. 

Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 
ATTACHMENT A 

DEFINITIONS 

Note: The attached Order may not contain some of the terms defined below. 

"Chemical name" means the scientific 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 of 

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 not 

limited to: full body protective clothing, boots, coveralls, gloves, jackets, and pants. 

"Company" means the person or persons subj ect 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 establislnnent or painting contractor). 

"Common name" means any designation or identification such as code name, code number, 

trade name, brand name, or generic chemical name used to identify a chemical substance other 

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 pennanent 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 part of a mixture, 

sold or made available to consumers for their use in or around a pennanent 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. For 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 

manufactnre and impOli these PMN substances 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. 
"Immediate use." A chemical 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, penneation, or penetration of the 

chemical protective clothing under the conditions of, and the duration of, exposure. 

"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. 

"NIOSH" means the National Institute for Occupational Safety and Health of the U.S. 

Department of Health and Hwnan 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 manufactured, processed, or otherwise 

used where significant direct contact of the bulk chemical substance and the workplace air may 

occur. 

"Non-industrial use" means use other than at a facility where chemical substances or 

mixtures are manufactured, imported, or processed. 

"PMN substance" means the chemical substance described in the Premanufacture 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 are 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 (,hemical 

substance, regardless of physical state or concentration, through all intended operations of 

processing, including the cleaning of equipment. 

"Scientifically invalid" means any significant departure from the EPA reviewed protocol or 

the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

review that prevents a reasoned evaluation of the health or environmental effects of the PMN 

substance. 

"Scientifically equivocal data" means data which, although developed in apparent 
confonnity with the Good Laboratory Practice Standards and EPA reviewedprotocols, are 

inconclusive, internally inconsistent, or otherwise insufficient to pennit a reasoned evaluation of 

the potential risk of injury to human health or the environment ofthe PMN substance. 

"Sealed container" means a closed container that is physically and chemically suitable for 

long-tenn containment of the PMN substance, and from which there will be no human exposure to, 

or environmental release of, the PMN substance during transport and storage. 

"Use stream" means all reasonably anticipated transfer, flow, or disposal of a chemical 

substance, regardless of physical state or concentration, through all intended operations of 

industrial, commercial, or consumer use .. 

"Waters ofthe 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 substance is 

manufactured, processed, or used and where employees are present. 

"Workplace" means an establishment at one geographic location containing one or more 

work areas. 
ATTACHMENT B 

STATISTICAL ANALYSIS OF NCELsANALYTICAL METHOD 

VERIFICATION RESULTS 

This Attachment describes the statistical teclmique (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: 

10 Compute means of the data measured by two laboratOlies. 

10 Compute mean squares 

10 Form the ratio 

10 Compute degrees of freedom 

where, 

-

Xl = Average of the results from the company laboratory 

X2 = Average of the results fi-om the independent laboratory 

nl = Number of samples analyzed by the company laboratory 

n2 = Number of samples analyzed by the independent laboratory. 
2 

Then compare the absolute value ofT to the 97.5 percentile point ofa t distribution with f 

degrees offi:eedom. 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 a t distribution with f degrees of freedom. 

EXAMPLES -- The following examples (based on simulated data) illustrate the method: 

Example 1 

XI = 83.30 

Data Set 1 

80.56 

100,01 

86;04 

52.61 

84.85 

95.75 

Absolute value ofT = 2.467 

sl= 9.26 

f= 5.33 

Data Set2 

97.11 

1'02.13 

99.83 

97.83 

105.44 

100.04 

n2 = 6 

The t table shows that the 97.5 percentile point is 2.571 and 2.447 for 5 and 6 degrees of 

freedom, respectively. For 5.33 degrees offreedom, the 97.5 percentile point will be 

approxirnately 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 of T is greater than 2.228, the 

97.5 percentile point for the t distribntion with 10 degrees of freedom. 

Example 2 

Data Set 1 Data Set 2 

82.87 108.05 

101.85 96.51 

87.44 100.04 

99.68 104.33 

101.15 110.32 

99.21 107.00 
3 

- - Xl = 95.37 nI = 6 X2 = 104.37 

SII = 65.59 WI = 10.93 sl =27.25 W2 =4.54 

Absolute value ofT = 2.290 f= 8.54 

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 oftwo data sets are 

significantly different at the 5% level. 
Company (Transferor) 

ATTACHMENT C 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

PMNNumber 

I. Transfer of Manufacture Rights. 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 

the subject of a premanufacture notice ("PMN") and is governed by a Consent Order issued by the 

U.S. Environmental Protection Agency ("EPA") under the authority of §5(e) of the Toxic 

Substances Control Act ("TSCA," IS U.S.C. §2604(e». 

2. Assumption of Liability. 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 PMN substance, shall 

be the responsibility of the Successor in Interest. Successor in Interest also certifies that it is 

incorporated, licensed, or doing business iI1 the United States in accordance with 40 CFR 

nO.22(a)(3) .. 

3. Confidential Business Information. The Successor in Interest hereby: 

_ reasserts, 

_ relinquishes, or 

modifies 

all Confidential Business Infonnation ("CBI") 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. Infonnation which 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. 
1 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

Company (Transferor) 

Signature of Authorized Official 

NOTICE OF TRANSFER 

(continued) 

PMNNumber 

Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Succ.essor in Interest 

Signature of Authorized Official Date 

Printed Name of Authorized Official 

Title of Authorized Official 

Address 

City, State, Zip Code 
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION See) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Successor's Technical Contact 

Address 

City, State, Zip Code 

Phone