TSCA Section 5(e) Modified Consent Order and 

Determinations Supporting Consent Order 

Premanufacture Notice (PMN) P-95-1098

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UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

OFFICE OF POLLUTION PREVENTION AND TOXICS 

REGULATION OF A NEW CHEMICAL SUBSTANCE 

PENDING DEVELOPMENT OF INFORMATION 

 In the matter of: ) Premanufacture Notice Number: 

 ) 

 ) 

 ) 

 ) 

 ) 

 Cytec Industries, Inc. ) P-95-1098 

 ) 

 ) 

 ) 

 ) 

 ) 

_________________________________________________________________ 

Modified Consent Order and Determinations Supporting Consent Order 

_________________________________________________________________ 

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TABLE OF CONTENTS 

Preamble

I. Introduction 

II. Summary of Terms of the Order 

III. Contents of PMN 

IV. EPA’s Assessment of Risk 

V. EPA’s Conclusions of Law 

Modified Consent Order

I Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation of Information 

III. Recordkeeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A - Definitions 

Attachment B - Statistical Analysis of NCELs Analytical Method Verification Results 

Attachment C - Notice of Transfer of Consent Order 

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PREAMBLE

I. INTRODUCTION

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

2604(e)), the Environmental Protection Agency (“EPA” or “the Agency”) issues the attached 

Modified Order regarding premanufacture notice (“PMN”) P-95-1098 for the chemical substance 

[ ] (the “PMN substance”) 

submitted by Cytec Industries, Inc. (“the Company”) to take effect upon signature by both 

parties. The Company submitted the PMN to EPA pursuant to section 5(a)(1) of TSCA and 40 

CFR Part 720. 

The original Consent Order became effective on April 29, 1997. It prohibits the 

manufacture and importation of the PMN substance beyond the volume of [ ] 

unless Cytec Industries Incorporated conducts and submits the prenatal developmental toxicity 

study identified in the Testing section of the Order. In addition, the Release to Water section of 

the Order prohibits any purposeful release of the PMN substance which would result in surface 

water concentrations exceeding 40 parts per billion (ppb). The Order did not require submission 

of a daphnid chronic toxicity test or the fish early-life stage toxicity test but recommended that 

these tests would provide relevant information to address potential environmental effects. 

Based on the test data indicating that the PMN substance may present an unreasonable 

risk of injury to human health, EPA is now modifying the current 5(e) Consent Order to reflect 

the risk-based human health findings. 

 Paragraph VI. (Information Required To Evaluate Environmental Effects) in the 

Preamble and the entire Testing section have been removed from the Order. Paragraphs (g)(1) 

and (g)(2) (Environmental hazard, exposure, and precautionary statements) have been removed 

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from the Hazard Communication Program section and paragraphs (f)(1)(ii), (f)(1)(iv), (f)(1)(ix), 

(f)(2)(ii) and (f)(2)(iv) will be added to the Hazard Communication Program section. The 

Protection in the Workplace section, New Chemical Exposure Limit section and Attachment B

Statistical Analysis of NCEL Analytical Method Verification Results has been added to the 

Order. The Recordkeeping section of the Order has been amended to: (a) remove all provisions 

pertaining to concerns for disposal and release to water and (b) add provisions for personal 

protective equipment and hazard communication. 

II. SUMMARY OF TERMS OF THE ORDER

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

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

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

PMN substance at or below a specified New Chemical Exposure Limit (“NCEL”) of 1.0 mg/m3

, 

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

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

and submitted to EPA.); 

(3) label the PMN substance and provide Material Safety Data Sheets (“MSDS”) and worker 

training in accordance with the provisions of the Hazard Communication Program section; and 

(4) maintain certain records. 

III. CONTENTS OF PMN

By signing this Order, the Company represents that it has carefully reviewed this 

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

is correctly identified within brackets and that any information that is not bracketed is not 

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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): 

Specific chemical identity, production volume, specific use, processing information, and other 

information. 

Chemical Identity: 

Specific: [ ] 

Generic: Tris carbamoyl Triazine. 

Use: 

Specific: [

 [ ] 

Generic: Crosslinking resin. 

Maximum 12-Month Production Volume: [ ] kilograms per year. 

Test Data Submitted with PMN: Physical and chemical properties (including IR, H1 NMR and 

C13 MNR Spectra); acute oral toxicity in rats—no deaths at 5,000 mg/kg, lethargy, flaccid 

muscle tone, ataxia, prostration, negative righting reflex, piloerection; acute dermal/ocular 

irritation study in rabbits—no deaths or signs of toxicity at 2,000 mg/kg, non-irritating to skin 

and eyes negative in mouse ear swelling test; negative Ames assay. In addition , negative in an 

in vitro chromosomal aberration assay; negative in the mouse micronucleus assay; no significant 

biodegradation was observed in a Modified Sturm and MITI 29 biodegradation assays; no 

significant bioaccumulation in a MITI compliant bioaccumulation study; acute toxicity to green 

algae was 72 hours EC50 = 16.0 mg/L based on biomass as cells/mL or 19.0 mg/L based on 

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biomass as area under the growth curve and 72 hour Er50 = 114.8 mg/L based on growth rate; 

acute toxicity to rainbow trout 96 hour LC50 = 4.4 mg/L; the acute toxicity to daphnia magna 48 

hour EC50 = 19.4 mg/L; a 28-day repeated dose study in the rat which included a Functional 

Observation Battery (FOB) analysis demonstrated no indications of neurotoxicity and established 

a NOEL of 15 mg/kg/day. 

IV. EPA’S ASSESSMENT OF RISK

The following are EPA’s predictions regarding the probable human and environmental 

toxicity, human exposure and environmental release of the PMN substance, based on the 

information currently available to the Agency. 

Human Health Effects Summary:

Absorption: Absorption is expected to be nil through the skin based on physical/chemical 

properties and moderate through the lungs and GI tract based on structurally similar [ . 

Toxicological Endpoints of Concern: The PMN poses a risk of systemic toxicity to workers 

being exposed via inhalation to the PMN substance. 

Basis: 

The Company submitted a prenatal developmental toxicity study to EPA for review. 

EPA determined that the prenatal developmental toxicity study was scientifically valid. The 

prenatal developmental toxicity study showed a no observable effect level (NOEL) of 30 and 

1,000 mg/kg/day for maternal and fetal toxicity, respectively. During the initial review of the 

PMN, the Company submitted a 28-day rat study which showed a NOEL and lowest observable 

effect level (LOEL) of 15 and 150 mg/kg/day, respectively, for systemic effects. The risk 

associated with occupational inhalation exposure to the PMN substance was calculated using the 

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prenatal developmental toxicity study and the 28-day rat study on the PMN substance. In the 

absence of protective equipment, [ ] use workers are expected to be involved in any hands-on 

“touch-up” spray applications that would occur less than [ ] per year. When the NOELs 

of 15, 30, and 1,000 mg/kg/day are divided by predicted workers exposure of 30 mg/day, EPA 

calculates margins of exposure (MOEs) of 35, 70 and 2,300, respectively, based on the 

supposition of 5 days week inhalation exposure. The calculated MOEs of 35 (maternal toxicity) 

and 70 (systemic effects) are below the MOE of 100 that EPA considers safe when calculated 

based on a NOEL. 

Environmental Effects Summary:

 Based on structurally similar [ ], during the initial review, the concentration of 

concern (COC) was established at 40 parts per billion (ppb). 

 The company submitted the chronic daphnid and fish early life stage toxicity studies to 

EPA for review. EPA has determined that the studies were scientifically valid. The results of 

chronic daphnid and fish early life stage studies showed that fish were the most sensitive species. 

EPA established a new COC at 66 ppb of the PMN substance in surface waters. EPA performed 

an e-fast model indicating that releases of the PMN substance to surface waters will not exceed 

the new COC. Thus the Agency does not expect the PMN substance to pose a significant risk to 

the aquatic environment, and therefore, is removing release to water restrictions from the Order. 

Exposure and Environmental Release Summary:

Manufacture Process Use 1 Use 2 

# Sites 

Workers 

(#/site) 

 

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Exposure 

(days/year) 

 

Dermal Exposure 

(mg/day) 

 < 1950 < 1950 < 741 < 78 

Inhalation Exposure 

(mg/day) 

 Negligible Negligible < 30 Negligible 

Risk to Workers:

 The PMN substance poses a risk of systemic toxicity to use workers being exposed via 

inhalation to workers being exposed during [ . 

NIOSH Assigned Protection Factor (“APF”): 5 

New Chemical Exposure Limit: 1.0 mg/m3

 as an 8-hour time-weighted average (“TWA”). 

V. EPA’S CONCLUSIONS OF LAW

The following findings constitute the basis of the Consent Order: 

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

substance. 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 

effects of the PMN substance. 

 (b) In light of the potential risk of systemic effects posed by the uncontrolled manufacture, 

import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has 

concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, 

processing, distribution in commerce, use, and disposal of the PMN substance may present an 

unreasonable risk of injury to human health. 

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VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS

. 

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

following effects which may be caused by the PMN substance: 

Information Guidelines

90-day Subchronic Inhalation OPPTS 870.3465 

Toxicity Test, Rats 

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, import, processing, 

distribution in commerce, use, and disposal of the PMN substance will remain in effect until the 

Order is modified or revoked by EPA based on submission of that or other relevant information. 

. 

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(2) De Minimis Concentrations. The requirements of this Order do not apply to quantities 

of the PMN substance that are (1) present in the work area only as a mixture and (2) at a 

concentration not to exceed 1.0 percent by weight or volume (0.1 percent by weight or volume if 

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

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

has reason to believe that, during intended activities, the PMN substance in the 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. 

 (3) Export. Until the Company begins commercial manufacture of the PMN substance for 

use in the United States, the requirements of this Order do not apply to manufacture, processing or 

distribution in commerce of the PMN substance solely for export in accordance with TSCA §12(a) 

and (b), 40 CFR 720.3(s) and 40 CFR Part 707. However, once the Company begins to 

manufacture the PMN substance for use in the United States, no further activity by the Company 

involving the PMN substance is exempt as “solely for export” even if some amount of the PMN 

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

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

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

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

Testing section of this Order. 

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(4) Research & Development (“R&D”). The requirements of this Order do not apply to 

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance in 

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

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

manufacturing, processing, distribution in commerce, use and disposal of the PMN substance when 

manufactured solely for non-commercial research and development per 40 CFR 720.30(i) and 

TSCA §5(i). 

(5) Byproducts. The requirements of this Order do not apply to the PMN substance when 

it is produced, without separate commercial intent, only as a “byproduct” as defined at 40 CFR 

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

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

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

with no commercial purpose separate from the substance, mixture, or article of which it is a part. 

(7) Imported Articles. The requirements of this Order do not apply to the PMN substance 

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

CFR 720.22(b)(1). 

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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 the PMN substance in the United States, for any nonexempt 

commercial purpose, pending the development of information necessary for a reasoned evaluation 

of the human health effects of the substance, and the completion of EPA’s review of, and 

regulatory action based on, that information, except in accordance with the conditions described in 

this Order. 

PROTECTION IN THE WORKPLACE

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

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

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

must establish a program whereby: 

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

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

section, is provided with, and is required to wear, at a minimum, a National Institute for 

Occupational Safety and Health (“NIOSH”)-certified respirator with an Applied Protection Factor 

(“APF”) of 5, from the respirators listed in subparagraph (a)(3) of this section, and the respirator is 

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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. 

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

listed for subparagraphs (a)(1) of this section: 

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

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

minimum requirements for subparagraph (a)(1) of this section: 

 Particulate, APF of 5

(i) Particulate/Aerosol/Mist Exposures, APF 5: 

(I) NIOSH-certified air-purifying, tight-fitting half-face respirator equipped 

with N100 (if oil aerosols absent), R100, or P100 filters

(II) NIOSH-certified air-purifying, tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, or P100 filters. 

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

loose- fitting hood or helmet and high efficiency particulate air (“HEPA”) filters. 

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

tight-fitting facepiece (either half-face or full-face) and HEPA filters. 

(V) NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow mode 

and equipped with a hood or helmet, or tight-fitting facepiece (either half- face or full-face).

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NEW CHEMICAL EXPOSURE LIMIT

(a) Alternative 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 the PMN substance 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 of this 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 the 

PMN substance, 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 the PMN 

substance by inhalation. 

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

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

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

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

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

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

person is exposed to an airborne concentration of the PMN substance in excess of 1.0 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 by the following equation: NCELn = NCEL x (8/n) x 

[(24-n)/16], where n = the number of hours in the actual work-shift. 

 (2) Automatic Sunset. If, subsequent to the effective date of this 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 this PMN 

substance 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 

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

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

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

substance. 

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

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

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

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

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

(10). 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 the PMN substance 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: “NCEL Sampling and 

Analytical Method for PMN #______,” after-which the correct PMN number for this chemical 

substance shall be stated. 

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

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

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

with the other requirements in this subsection (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 720.3(x)) from 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 

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

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

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

Standards (“GLPS”) at 40 CFR Part 792. [

] 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 Industrial Hygiene Association (“AIHA”) 

Industrial Hygiene Laboratory Accreditation Program (“IHLAP”); or (B) another comparable 

program approved in advance in writing by EPA. 

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

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

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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 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: 

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

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

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

conditions or, for solids and liquids with very 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 

performed 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 

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

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

the method description. 

 (vii) Comparison of Results. The difference between the results of the 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 of NCELs 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 sampling 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 the PMN substance ranging from one half the NCEL to twice the NCEL. 

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

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

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

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

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

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

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

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

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

when possible, even if the required amplification is beyond that 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 

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

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

(v) Calculated Percent Recovery.

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

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

from a sample containing a known quantity of the PMN substance. 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 1 matrix spike, prepared by injecting the PMN substance 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 

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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 those expected in the workplace. Breakthrough is 

defined to have occurred when the concentration of the PMN substance in the effluent stream is 

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

detected in the backup section of the sampler. 

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

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

with the PMN substance at least the NCEL concentration must be prepared. A recovery of at least 

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

(5) 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 0.105, including allowance of 0.05 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 re-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 75%, correction for low 

recovery is required. Correct for recovery first by dividing the observed amount by the proportion 

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

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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 

mimic the actual workplace environment expected to be monitored. Conditions such as the 

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

the workplace to be monitored. 

(8) Changes Affecting Validity. If the 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 to the workplace which may interfere with the analysis of the new 

chemical; introduction of light to the workplace which may interfere with a light-sensitive PMN 

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

PMN substance and cause difficulties in collection and analysis. 

(9) Comparability. All data and results shall be reported in the same units of measurement 

as the NCEL. 

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

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

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

ensuring the validity of its exposure monitoring data. 

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(d) Monitoring Potential Exposure.

(1) General.

(i) Action Level. The “action level” is defined as an airborne concentration of the 

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

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

the NCELn. (The NCELn is described in subparagraph (b)(1)(ii).) The Company may exceed the 

action level without penalty. The purpose of the action level is solely to determine 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 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 performing 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 the PMN substance is reasonably likely to 

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

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

(iii) Good Laboratory Practice Standards. Determinations 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 

EPA SANITIZED Page 26 of 62
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Chemical Exposure Limit section. 

] However, compliance with TSCA GLPS is not required 

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 the PMN substance for each exposure group 

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

(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 the PMN 

substance is 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 

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of the PMN substance is resumed. However, cessation of manufacturing, processing and use of 

the PMN substance 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 the PMN substance is not 

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

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

substance is resumed. However, cessation of manufacturing, processing and use of the PMN 

substance for less than the 3 month period does not constitute grounds for postponement of the 3 

month deadline to conduct exposure monitoring. 

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

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

at 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 the PMN substance is manufactured, processed, or used in 

batches of duration less than 7 days, the 2 consecutive measurements may be taken at least 24 

hours apart, provided that the measurements accurately reflect the highest peak exposures and 

variability in exposure. 

(4) Termination of Monitoring.

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

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

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

this New Chemical Exposure Limit section. 

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

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

apart, 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 

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

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

provided that the measurements accurately reflect the highest peak exposures and 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 the PMN substance; 

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

cause new or additional exposures to the PMN substance; and, 

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

may reasonably result in new or additional exposures to the PMN substance. 

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(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 deemed appropriate by the best professional judgment of a qualified expert. 

(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 information 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 shall 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 and 

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

the PMN substance will not exceed the action level (defined in paragraph (d)(1)(i)) under the 

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

(d)(1)(ii)), then that exposure group is exempt from this New Chemical Exposure Limit section 

EPA SANITIZED Page 30 of 62
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(except paragraph (d)(5) “Additional Monitoring” and subsection (f) “NCEL Record-keeping”) 

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

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

must 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 substance. Examples of objective data that may be used to demonstrate 

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

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

and/or laboratory test results. 

(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 the PMN substance for any person who is reasonably likely to be 

exposed to the PMN substance 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 of this 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 CFR 1910.134 and 42 CFR Part 84. When the Company has not yet 

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

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

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

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(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 the PMN substance by inhalation use, at a minimum, the respiratory protection which 

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

respirator which corresponds to a concentration higher than measured). 

PARTICULATE RESPIRATOR TABLE

Measured Required Respiratory Protection

Concentration 

of PMN Substance

≤ NCEL  No respiratory protection is required. 

≤ 10 x NCEL  NIOSH-certified air-purifying, tight-fitting half-face respirator equipped 

with N100 (if oil aerosols absent), R100, or P100 filters 

  NIOSH-certified air-purifying, tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, or P100 filters. 

  NIOSH-certified powered air-purifying respirator equipped with a loosefitting hood or helmet and high efficiency particulate air (“HEPA”) filters. 

  NIOSH-certified powered air-purifying respirator equipped with a tightfitting facepiece (either half-face or full-face) and HEPA filters 

  NIOSH-certified supplied-air respirator operated in pressure demand or 

continuous flow mode and equipped with a hood or helmet, or tight-fitting 

facepiece (either half-face or full-face

≤ 25 x NCEL  NIOSH-certified air-purifying, tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, or P100 filters. 

  NIOSH-certified powered air-purifying respirator equipped with a loosefitting hood or helmet and HEPA filters. 

EPA SANITIZED Page 32 of 62
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  NIOSH-certified powered air-purifying respirator equipped with a tightfitting facepiece (either half-face or full-face) and HEPA filters. 

  NIOSH-certified supplied-air respirator operated in pressure demand or 

continuous flow mode and equipped with a hood or helmet, or tight-fitting 

facepiece (either half-face or full-face). 

≤ 50 x NCEL  NIOSH-certified air-purifying, tight-fitting full-face respirator equipped 

with N100 (if oil aerosols absent), R100, or P100 filters. 

  NIOSH-certified powered air-purifying respirator equipped with a tightfitting facepiece (either half-face or full-face) and HEPA filters. 

  NIOSH-certified supplied-air respirator operated in pressure demand or 

continuous flow mode and equipped with a tight-fitting facepiece (either 

half-face or full-face 

≤ 2000 x NCEL  NIOSH-certified supplied-air respirator operated in pressure demand or 

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

> 2000 x NCEL  Any self-contained respirator equipped with a full facepiece and 

operated in a pressure demand or other positive pressure mode. 

  Any supplied-air respirator equipped with a full facepiece operated in a 

pressure demand or other positive pressure mode in combination with an 

auxiliary self-contained breathing apparatus operated in a pressure demand 

or other positive pressure mode.

(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 

EPA SANITIZED Page 33 of 62
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appropriate in accordance with paragraph (e)(2). Where the PMN substance is manufactured, 

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

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

exposures and variability in exposure. 

(4) Special Situations.

(i) Measurements Outside Quantitation 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)(3). The Company may 

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

New Chemical Exposure Limit section, including the verification required by subsection (c)(3). 

(ii) Cleanup and Remedial Actions. During any special cleanup or other remedial 

actions that may occur before commencing additional exposure monitoring (as discussed in 

paragraph (d)(5)(ii)), the Company shall ensure that potentially exposed persons use at least the 

respiratory protection specified above in this subsection (e) for the measured airborne 

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

professional judgment of a qualified expert. 

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(f) NCEL Recordkeeping.

(1) 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 EPA in accordance with 

section 11 of TSCA: 

(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 certification statement and the 

verification results obtained by both laboratories; 

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

Standards at 40 CFR Part 792, or use of a laboratory accredited by the American Industrial 

Hygiene Association (“AIHA”) or another comparable program approved in advance in writing by 

EPA. Where the Company elects to not comply with TSCA GLPS, such records shall include the 

written 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 

intended to represent; 

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(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 

the PMN substance; 

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

cause new or additional exposure; 

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

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

substance; 

(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 

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 the PMN substance in each workplace. The written 

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

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

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

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

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

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

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

include the following: 

(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.F.R. Part 721, subpart E. The list must be maintained in each work area where the PMN 

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

substance required under paragraph (c) of this 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) of TSCA, or by a TSCA section 5(a)(2) SNUR at 40 CFR 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 of the hazards of non-routine 

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

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

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

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

contractor work in the Company’s workplace and are reasonably likely to be exposed to the PMN 

substance while in the Company’s workplace. 

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(b) Labeling.

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

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

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

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

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

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

recognized. 

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

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

substance. 

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

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

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

procedures, or other such written materials in lieu of affixing labels to individual stationary process 

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

conveys information specified by subparagraph (b)(1)(i) 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 the PMN 

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

use of the employee who performs the transfer. 

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

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

re-labeled with the information specified in subparagraph (b)(1)(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: 

(I) The information prescribed in subparagraph (b)(1)(i) 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. 

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

PMN substance 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 

CFR 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 control worker exposure or environmental release 

EPA SANITIZED Page 39 of 62
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which the Company determines provide the greatest degree of protection. However, should these 

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

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

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

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

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

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

information. If the PMN substance is not being manufactured, imported, processed, or used in the 

Company’s workplace, the Company must add the new information to the label before the PMN 

substance is reintroduced into the workplace. 

 (c) Material Safety Data Sheets.

(1) The Company must obtain or develop an MSDS for the PMN substance. 

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

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

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

If the chemical and common name is claimed confidential, a generic chemical name must be used. 

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

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

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

potential for fire, explosion, and reactivity. 

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(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 the PMN substance known to the Company. 

(vi) The primary routes of exposure to the PMN substance. 

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

release required by this Order, or alternative control measures which EPA has determined 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) of the New Chemical Exposure Limit section. 

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

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

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

to spills and leaks. 

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

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. 

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(3) If no relevant information is found or known for any given category on the MSDS, the 

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

(4) Where multiple mixtures containing the PMN substance 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 the PMN substance or ways to protect against the hazards, this new information must be 

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

information. If the PMN substance is not being manufactured, imported, processed, or used in the 

Company’s workplace, the Company must add the new information to the MSDS before the PMN 

substance is reintroduced into the workplace. 

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

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

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

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

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

that it is readily accessible during 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 the PMN substance and must be readily accessible 

EPA SANITIZED Page 42 of 62
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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 the PMN substance. This information and training must be 

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

substance and whenever the PMN substance is introduced into the employee’s work area for the 

first time. 

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

(i) The requirements of this section. 

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

(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 employees shall include: 

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

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

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

being released). 

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

as specified in paragraph (f) of this section. 

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

from the PMN substance, including specific procedures the Company has implemented to protect 

employees and the environment from exposure to the PMN substance, 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 control 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) Existing Hazard Communication Program. The Company need not take additional actions if 

existing programs and procedures satisfy the requirements of this section. 

(f) Human Health, Environmental Hazard, Exposure, and Precautionary Statements. The 

following human health 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 this section: 

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

 (i) respiratory complications. 

 (ii) internal organ effects. 

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

 (i) avoid breathing the substance. 

EPA SANITIZED Page 44 of 62
- 35 -

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

below an 8-hour time-weighted average of 1.0 mg/m3

 (3) 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.” 

III. RECORDKEEPING

(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 of TSCA: 

(1) Exemptions. Records documenting that the PMN substance did in fact qualify for any 

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

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

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

eligible for the Export exemption in Section I, Paragraph (b)(3) 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)(1)(B) and 12(b), respectively. Any amounts or batches of the PMN substance 

eligible for the Research and Development exemption in Section I, Paragraph (b)(4) 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 the PMN substance claimed to be eligible for any other exemption described 

EPA SANITIZED Page 45 of 62
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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 from the other recordkeeping requirements in this Recordkeeping section; 

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

and the corresponding dates of manufacture 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 the PMN substance, the date of each sale or transfer, and the quantity of 

the substance sold or transferred on such date; 

(4) Records documenting the address of all sites of manufacture, import, processing, and 

use; 

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

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

section of this Order; 

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

this Order, if applicable; 

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

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

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

Order; 

EPA SANITIZED Page 46 of 62
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(9) Copies of Material Safety Data Sheets required by the Hazard Communication 

Program section of this Order; 

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

section of this Order, if applicable; and 

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

substance is 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 currently 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 currently valid 

OMB Control Number 2070-0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

(a) EPA’s Request for Information. Pursuant to section 11 of TSCA and 40 CFR 720.122, EPA 

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

associated with the PMN substance. To facilitate such inspections, EPA personnel may contact the 

EPA SANITIZED Page 47 of 62
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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 the PMN substance will be in production within the 

subsequent 12 months; 

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

the PMN substance and may reasonably be exposed to the PMN substance; 

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

with the PMN substance and may reasonably be exposed to the PMN substance; 

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

associated with the PMN substance and may reasonably be exposed to the PMN substance; 

(v) Records required by the Recordkeeping section of this Order; and/or 

(vi) Any other information reasonably related to determining compliance with this Order 

or conducting an inspection for that purpose. 

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

period of time, but in no event later than 30 days after receiving EPA’s request. When requested 

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. 

EPA SANITIZED Page 48 of 62
- 39 -

(c) Confidential Business Information. Any Confidential Business Information (“CBI”) that the 

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

TSCA and 40 CFR Part 2. 

V. 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 the PMN 

substance, including the right to manufacture the PMN substance, 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 the PMN 

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

new PMN to EPA and comply fully with Section 5(a)(1) of TSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 

(2) After NOC. If the transfer from the Company to the Successor in Interest is effective 

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

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

EPA SANITIZED Page 49 of 62
- 40 -

(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 the PMN substance, 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 the PMN substance, such as a licensee who has acquired a limited 

license to the patent or manufacturing rights associated with the PMN substance. A Successor in 

Interest must be incorporated, licensed, or doing business in the United States in accordance with 

40 CFR 720.22(a)(3). 

(2) “Transfer Document” means the legal instrument(s) used to convey the interests in the 

PMN substance, including the right to manufacture the PMN substance, from the Company to the 

Successor in Interest. 

(d) Notices.

(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 days of the effective date of the transfer, the 

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

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

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

EPA SANITIZED Page 50 of 62
- 41 -

(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 the PMN substance is 

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 the PMN substance 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, distributed 

in commerce, or disposed of the PMN substance pursuant to the terms of this Consent Order. 

(f) Obligations to Submit Test Data under Consent Order. If paragraph (d) of the Testing section 

of this Consent Order requires the Company to submit test data to EPA at a specified production 

volume (“test trigger”), the aggregate volume of the PMN substance manufactured and imported 

by the Company up to the date of transfer shall count towards the test trigger applicable to the 

Successor in Interest. 

EPA SANITIZED Page 51 of 62
- 42 -

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, the PMN substance, to modify or revoke substantive provisions 

of this Order. The exposures and risks identified by EPA during its review of the PMN substance 

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 information 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 human exposure or substantial environmental release in the 

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

the PMN substance. 

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

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

modification is useful, appropriate, and consistent with the structure and intent of this Order as 

issued. 

EPA SANITIZED Page 52 of 62
- 43 - 

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) of TSCA, 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) of TSCA, 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 determinations 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 of TSCA, 40 CFR Part 720 Subpart E, and 40 CFR Part 2) 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. 

_________________ _____________________________________ 

Date Jim Willis, Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

_________________ _____________________________________ 

Date Name: 

 Title: 

Company: Cytec Industries, Inc.

EPA SANITIZED Page 53 of 62
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 subject to this Order. 

 “Commercial use” means the use of a chemical substance or any mixture containing the 

chemical substance in a commercial enterprise providing saleable goods or a service to consumers 

(e.g., a commercial dry cleaning establishment or painting 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 permanent or temporary household or residence, 

during recreation, or for any personal use or enjoyment. 

 “Consumer product” means a chemical substance that is directly, or as part of a mixture, 

sold or made available to consumers for their use in or around a permanent or temporary 

household or residence, in or around a school, or in recreation. 

 “Container” means any bag, barrel, bottle, box, can, cylinder, drum, reaction vessel, storage 

tank, or the like that contains a hazardous chemical. 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 

manufacture and import the PMN substance under the conditions specified in Part II. of this 

Consent Order and in the Consent Order for Contract Manufacturer. 

 “Identity” means any chemical or common name used to identify a chemical substance or a 

mixture containing that substance. 

EPA SANITIZED Page 54 of 62
 “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, permeation, 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 Human Services. 

 “Non-enclosed process” means any equipment system (such as an open-top reactor, storage 

tank, or mixing vessel) in which a chemical substance is 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 chemical 

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-approved protocol 

or the Good Laboratory Practice Standards at 40 CFR Part 792 without prior or subsequent Agency 

approval 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 

EPA SANITIZED Page 55 of 62
conformity with the Good Laboratory Practice Standards and EPA-approved protocols, are 

inconclusive, internally inconsistent, or otherwise insufficient to permit a reasoned evaluation of 

the potential risk of injury to human health or the environment of the PMN substance. 

“Sealed container” means a closed container that is physically and chemically suitable for 

long-term 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 of the United States” has the meaning set forth in 40 CFR 122.2. 

 “Work area” means a room or defined space in a workplace where the PMN 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. 

EPA SANITIZED Page 56 of 62
ATTACHMENT B 

STATISTICAL ANALYSIS OF NCELs ANALYTICAL METHOD 

VERIFICATION RESULTS 

This Attachment describes the statistical technique (with examples) for comparing the 

analytical results obtained by two laboratories pursuant to paragraph (c)(3)(vii) of the New 

Chemical Exposure Limit section of this Order. 

STATISTICAL TECHNIQUE 

To obtain two-sample t test with unequal variances, perform the following operations: 

● Compute means of the data measured by two laboratories. 

● Compute mean squares 

 _ 

Si

2

 = ∑(Xij - Xi)

2

/(ni - 1), i=1, 2 

● Form the ratio 

 _ _ 

T = (X1 - X2)/(W1 + W2)

1⁄2

● Compute degrees of freedom 

f = (W1 + W2)

2

/[W1

2

/(n1 - 1) + W2

2

/(n2 - 1)] 

where, 

W1 = S1

2

/n1, i = 1, 2 

_ 

X1 = Average of the results from the company laboratory 

_ 

X2 = Average of the results from the independent laboratory 

n1 = Number of samples analyzed by the company laboratory 

n2 = Number of samples analyzed by the independent laboratory. 

EPA SANITIZED Page 57 of 62
2 

Then compare the absolute value of T to the 97.5 percentile point of a t distribution with f 

degrees of freedom. If the absolute value exceeds the 97.5 percentile point, the results measured 

by two laboratories are significantly different at 95% level. Otherwise, they are not significantly 

different. In general, f may 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 

Data Set 1 Data Set 2

 80.56 97.11 

 100.01 102.13 

 86.04 99.83 

 52.61 97.83 

 84.85 105.44 

 95.75 100.04 

_ _ 

X1 = 83.30 n1 = 6 X2 = 100.40 n2 = 6 

S1

1

 = 278.72 W1 = 46.25 S2

2

 = 9.26 W2 = 1.54 

Absolute value of T = 2.467 f = 5.33 

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 of freedom, the 97.5 percentile point will be 

approximately 2.530 which is greater than the absolute value of T, 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 distribution 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 

EPA SANITIZED Page 58 of 62
3 

 _ _ 

 X1 = 95.37 n1 = 6 X2 = 104.37 n2 = 6 

S1

1

 = 65.59 W1 = 10.93 S2

2

 = 27.25 W2 = 4.54 

Absolute value of T = 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 of T, 2.290. Hence, the means of two data sets are 

significantly different at the 5% level. 

EPA SANITIZED Page 59 of 62
ATTACHMENT C 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

___________________________ _________________ 

Company (Transferor) PMN Number 

1. 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,” 15 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 in the United States in accordance with 40 CFR 

720.22(a)(3). 

3. Confidential Business Information. The Successor in Interest hereby: 

___ reasserts, 

___ relinquishes, or 

___ modifies 

all Confidential Business Information (“CBI”) claims made by the Company, pursuant to Section 

14 of TSCA and 40 CFR part 2, for the PMN substance(s). Where “reasserts” or “relinquishes” is 

indicated, that designation shall be deemed to apply to all such claims. Where “modifies” is 

indicated, such modification shall be explained in detail in an attachment to this Notice of 

Transfer. Information 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.

EPA SANITIZED Page 60 of 62
1 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

___________________________________ _____________________ 

Company (Transferor) PMN Number 

___________________________________ _____________________ 

Signature of Authorized Official Date 

___________________________________ 

Printed Name of Authorized Official 

___________________________________ 

Title of Authorized Official 

___________________________________ 

Successor in Interest

___________________________________ _____________________ 

Signature of Authorized Official Date 

___________________________________ 

Printed Name of Authorized Official 

___________________________________ 

Title of Authorized Official 

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

EPA SANITIZED Page 61 of 62
2 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued)

___________________________________ 

Successor’s Technical Contact

___________________________________ 

Address 

___________________________________ 

City, State, Zip Code 

___________________________________ 

Phone 

EPA SANITIZED Page 62 of 62