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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: 

Great Lakes Chemical Corporation 

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P-04-244 

IIIVIJINMIIIIIqII!JI'IiYildll~911,91111f~,11 llll,llllll 

Consent Order and Determinations Supporting Consent Order 
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 

VI. Information Required to Evaluate Human Health Effects 

Consent Order 

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

Pending Submission and Evaluation of Information 

II . Record-keeping 

III. Successor Liability Upon Transfer of Consent Order 

IV. Modification and Revocation of Consent Order 

V. 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 
111 

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 

Order, regarding premanufacture notice ("PMN") P-04-244 submitted by Great Lakes Chemical 

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

Company submitted the PMN to EPA pursuant to section 5(a)(1) of TSCA and 40 CFR Part 720. 

Under § 15 of TSCA, it is unlawful for any person to fail or refuse to comply with any 

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

to both criminal and civil liability pursuant to § 16, and to specific enforcement and seizure 

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

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

II . SUMMARY OF TERMS OF THE ORDER 

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

(1 ) submit to EPA the following tiered toxicity testing at least 14 weeks before manufacturing or 

importing the following production volumes of the PMN substance: 

Test Production Volume 

(Kilograms) 

I Cardiac Sensitization (protocol 

to be provided by the company) 

II Systemic/Developmental Toxicity 

(OECD 422) in rats by the 

inhalation route but with a 10 week 

dosing period prior to mating. 

(Depending on the results of this study, 

test III may be required .) 
iv 

III Reproductive Toxicity Test (OECD 415) in 

rats by the inhalation route. 

IV Carcinogenicity (OPPTS 870 .4200) in rats 

by the inhalation route. 

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

(3) 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 0.5 mg/m3 

verified by actual 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.) ; 

(4) 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; 

(5) not use the PMN substance other than as described in the PMN; 

(6) distribute the PMN substance only to a person who agrees to follow the same restrictions 

(except the testing requirements) and to not further distribute the PMN substance until it has been 

completely reacted; and 

(7) maintain certain records. 
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III. CONTENTS OF PMN 

Confidential Business Information Claims (Bracketed in the Preamble and Order) : -Production 

volume and processing information are claimed as confidential business information by the 

Company. This document does not contain certain proprietary information submitted to EPA in 

a Letter of Support by a customer of the Company that processes the PMN substance. 

Chemical Identity: Ethane, 2-bromo-l,l-difluoro, CAS # 359-07-9. 

Use: Chemical Intermediate for a herbicide. 

Maximum 12-Month Production Volume: ~ 

Test Data Submitted with PMN: 

Rat oral LDo = 2,000 mg/kg. 

Rat dermal LDo = 2,000 mg/kg. 

Eye irritation (rabbits)-moderate . 

Skin irritation (rabbits)-no irritation . 

IV. EPA'S ASSESSMENT OF RISK 

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

and environmental release of the PMN substance, based on the information currently available to 

the Agency. 

Human Health Effects Summary. 

Absorption: EPA expects 100% of the PMN substance to be absorbed via the skin, lungs, and GI 

tract. 
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Occupational Exposure Summary: 

Manufacture Processing/Use ** 

# Sites ** 

Workers * * 

(#/site) 

Exposure ** 

(days/year) 

Dermal Exposure None Expected ** 

(mg/day) 

Inhalation Exposure <380 mg/day ** 

(mg/day) 

** Proprietary information from the processor/user. 

Risk to Occupational Workers. 

Based on acute data on the PMN substance, there is a potential risk of eye irritation to 

manufacture and use workers exposed to the PMN substance. Based on analogue data on other 

alkyl halides, EPA is concerned that, in the absence of protective measures, inhalation and 

dermal exposure of workers to the PMN substance may cause eye irritation, skin sensitization, 

systemic toxicity, developmental toxicity, reproductive toxicity and cancer. 

Respiratory Assigned Protection Factor (APF): 75 

New Chemical Exposure Limit: 0.5 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 

7 
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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 human health effects posed by the uncontrolled manufacture, 

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

Agency's conclusion that issuing the Order will not result in any significant loss of benefits to 

society, 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 . 

VI. INFORMATION REQUIRED TO EVALUATE HEALTH EFFECTS 

Triggered Testin~. The Order prohibits the Company from exceeding specified 

production volumes unless the Company submits the information described in the Testing 

section of this Order in accordance with the conditions specified in the Testing section. 
J~ .~ED STqT~S' UNITED STATES ENVIRONMENTAL PROTECTION AGENCY 

A y2 WASHINGTON, D.C. 20460 . 

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' OFFICE OF 

PREVENTION, PESTICIDES AND 

TOXIC SUBSTANCES 

CONSENT ORDER 

I. TERMS OF MANUFACTURE IMPORT, PROCESSING, 

DISTRIBUTION IN COMMERCE USE AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

The Great L.akes Chemical Corporation ("the Company") is prohibited. from. 

rnanufactuting, importing, processing, distributing in commerce, using, or disposing of'thc: 

chemical substance Ethane, 2-bromo-l .l-difluoro- ("the PMISf-substance") (P-04-244) 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, sr_..d the 

completion of EPA's review of, and regulatory action based on, that information,, exceptunder tile 

following conditions : 

TESTING 

(a) Section 8(e) Reportin~ Any information on the PMN substance which reasonably supports 

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

environment required to be reported under EPA's section 8(e) policy statement at 43 Federal 

Register 11110 (March 16, 1978) as amended at 52 Federal Register 20083 (May 29, 1987), 

shall reference the appropriate PMN identification number for this substance and shall contain a 

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internet Address (URL) ® http ://www .epa .gov 

Recycled/Recyclable -Printed with Vegetable Oil Based Inks on 100% Postconsumer, Process Chlorine Free Recycled Paper 
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statement that the substance is subject to this Consent Order. Additional information regarding 

section 8(e) reporting requirements can be found in the reporting guide referenced at 68 Federal 

Register 33129 (June 3, 2003) . . 

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

Data Integrity Branch (2225A), Office of Enforcement and Compliance Assurance, U.S. 

Environmental Protection Agency, 1200 Pennsylvania Avenue, N.W., Washington, D.C. 20460, 

of the following information within 10 days of scheduling any study required to be performed 

pursuant to this Order, or within 15 days after the effective date of this Order, whichever is later: 

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

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

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

EPA may contact regarding the study. 

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

the substance is subject to this Consent Order. 

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

performed pursuant to this Order must be conducted according to TSCA Good Laboratory 

Practice Standards at 40 CFR Part 792 and using methodologies generally accepted at the time 

the study is initiated. Before starting to conduct any such study, the Company must obtain 

approval of test protocols from EPA by submitting written protocols. EPA will respond to the 

Company within 4 weeks of receiving the written protocols. Published test guidelines specified 
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in paragrap h (d) provide general guidance for development of test protocols, but are not 

themselves acceptable protocols. 

(d) Triggered Testing Requirements. The Company is prohibited from manufacturing or 

importing the PMN substance beyond the following aggregate manufacture and import volumes 

("the production limits"), unless the Company conducts the following studies on the P1VIN 

substance and submits all final reports and underlying data in accordance with the conditions 

specified in this Testing section. 

Production Limit Study Guideline 

1 kilograms Cardiac Sensitization protocol to be 

provided by the 

Company 

Systemic/Developmental Toxicity OECD 422 

in rats by the inhalation route but with 

a 10 week dosing period prior 

to mating. 

kilograms Reproductive Toxicity OECD 415 

in rats by the inhalation route. 

kilograms Carcinogenicity OPPTS 870.4200 

in rats by the inhalation route. 

(e) Test Reports. The Company shall: (1) conduct each study in good faith; with due care, and 

in a scientifically valid manner; (2) promptly furnish to EPA the results of any interim phase of 

each study; and (3) submit, in triplicate (with an additional sanitized copy, if confidential 

business information is involved), the final report of each study and all underlying data ("the 

report and data") to EPA no later than 14 weeks prior to exceeding the applicable production 

if 
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limit. The final report shall contain the contents specified in 40 CFR 792.185 . Underlying data 

shall be submitted to EPA in accordance with the applicable "Reporting", "Data and Reporting", 

and "Test Report" subparagraphs in the applicable test guidelines . However, for purposes of this 

Consent Order, the word "should" in those subparagraphs shall be interpreted to mean "shall" to 

make clear that the submission of such information is mandatory. EPA will require the 

submission of raw data such as slides and laboratory notebooks only if EPA finds, on the basis 

of professional judgment, that an adequate evaluation of the study cannot take place in the 

absence of these items. 

(f) Testing Waivers. The Company is not required to conduct a study specified in paragraph (d) 

of this Testing section if notified in ting by EPA that it is unnecessary to conduct that study. 

For example, based on the results of the systemic/developmental toxicity test, EPA will 

determine whether the reproductive toxicity study is required. However, if the reproductive 

toxicity study is waived, the production volume limit for the carcinogenicity study will 

accordingly become L_ l kilograms. 

(g) Equivocal Data. If EPA finds that the data generated by a study are scientifically equivocal, 

the Company may continue to manufacture and import the PMN substance beyond the 

applicable production limit. To seek relief from any other restrictions of this Order, the 

Company may make a second attempt to obtain unequivocal data by reconducting the study 
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under the conditions specified in paragraphs (b), (c), and (e)(1) and (2). The testing 

requirements may be modified, as necessary to permit a reasoned evaluation of the risks 

presented by the PMN substance, only by mutual consent of EPA and the Company. 

(h) EPA Determination of Invalid Data. (1) Except as described in subparagraph (h)(2), if, 

within 6 weeks of EPA's receipt of a test report and data, the Company receives written notice 

that EPA finds that the data generated by a study are scientifically invalid, the Company is 

prohibited from further manufacture and import of the PMN substance beyond the applicable 

production limit. 

(2) The Company may continue to manufacture and import the PMN substance beyond 

the applicable production limit only if so notified, in writing, by EPA in response to the 

Company's compliance with either of the following subparagraphs (h)(2)(i) or (h)(2)(ii) . 

(i) The Company may reconduct the study in compliance with paragraphs (b), 

(c), and (e)(1) and (2). If there is sufficient time to reconduct the study and submit the report 

and data to EPA at least 14 weeks before exceeding the production limit as required by 

subparagraph (e)(3), the Company shall comply with subparagraph (e)(3) . If there is insufficient 

time for the Company to comply with subparagraph (e)(3), the Company may exceed the 

production limit and shall submit the report and data in triplicate to EPA within a reasonable 

period of time, all as specified by EPA in the notice described in subparagraph (h)(1) . EPA will 

respond to the Company, in writing, within 6 weeks of receiving the Company's report and data. 
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(ii) The Company may, within 4 weeks of receiving from EPA the notice 

described in subparagraph (h)(1), submit to EPA a written report refuting EPA's finding. EPA 

will respond to the Company, in writing, within 4 weeks of receiving the Company's report . 

(i) Company Determination of Invalid Data. (1) Except as described iii subparagraph (i)(2), if 

the Company becomes aware that circumstances clearly beyond the control of the Company or 

laboratory will prevent, or have prevented, development of scientifically valid data under the 

conditions specified in paragraphs (c) and (e), the Company remains prohibited from further 

manufacture and import of the PMN substance beyond the applicable production limit. 

(2) The Company may submit to EPA, within 2 weeks of first becoming aware of such 

circumstances, a written statement explaining why circumstances clearly beyond the control of 

the Company or laboratory will cause or have caused development of scientifically invalid data. 

EPA will notify the Company of its response, in writing, within 4 weeks of receiving the 

Company's report . EPA's written response may either : 

(i) allow the Company to continue to manufacture and import the PMN 

substance beyond the applicable production limit, or 

(ii) require the Company to continue to conduct, or to reconduct, the study in 

compliance with paragraphs (b), (c), and (e)(1) and (2). If there is sufficient time to conduct or 

reconduct the study and submit the report and data to EPA at least 14 weeks before exceeding 

the production limit as required by subparagraph (e)(3), the Company shall comply with 

subparagraph (e)(3) . If there is insufficient time for the Company to comply with subparagraph 

(e)(3), the Company may exceed the production limit and shall submit the report and data in 
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triplicate to EPA within a reasonable period of time, all as specified by EPA in the notice 

described in subparagraph (i)(2) . EPA will respond to the Company, in writing, within 6 weeks 

of receiving the Company's report and data, as to whether the Company may continue to 

manufacture and import beyond the applicable production limit. 

(j) Unreasonable Risk. (1) EPA may notify the Company in writing that EPA finds that the 

data generated by a study are scientifically valid and unequivocal and indicate that, despite the 

terms of this Order, the PMN substance will or may present an unreasonable risk of injury to 

human health or the environment. EPA's notice may specify that the Company undertake certain 

actions concerning further testing, manufacture, import, processing, distribution, use and/or 

disposal of the PMN substance to mitigate exposures to or to better characterize the risks 

presented by the PMN substance. Within 2 weeks from receipt of such a notice, the Company 

must cease all manufacture, import, processing, distribution, use and disposal of the PMN 

substance, unless either : 

(2) within 2 weeks from receipt of the notice described in subparagraph (j)(1), the 

Company complies with such requirements as EPA's notice specifies; or 

(3) within 4 weeks from receipt of the notice described iii subparagraph (j)(1), the 

Company submits, to EPA a written report refuting EPA's finding and/or the appropriateness of 

any additional requirements imposed by EPA. The Company may continue to manufacture, 

import, process, distribute, use and dispose of the PMN substance in accordance with the terms 

of this Order pending EPA's response to the Company's written report. EPA will respond to the 

Company, in writing, within 4 weeks of receiving the Company's report . Within 2 weeks of 
receipt of EPA's written response, the Company shall comply with any requirements imposed by 

EPA's response or cease all manufacture, import, processing, distribution, use and disposal of 

the PMN substance. 

(k) Other Requirements . Regardless of the satisfaction of any other conditions in this Testing 

section, the Company must continue to obey all the terms of this Consent Order until otherwise 

notified in writing by EPA. The Company may, based upon submitted test data or other relevant 

information, petition EPA to modify or revoke provisions of this Consent Order pursuant to Part 

IV. of this Consent Order. 

PROTECTION IN THE WORKPLACE 

(a) During manufacturing, processing, and use of the PMN substance at any site controlled by 

the Company, 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)(3) of 

this section, is provided with, and is required to wear, at a minimum, a NIOSH-approved 

respirator with an assigned protection factor (APF) of 75, from one of the categories listed in 

subparagraph (a)(2) of this section, and the respirator is used in accordance with 29 CFR 

1910.134 and 42 CFR Part 84. 

(2) Authorized Respirators. The following NIOSH-approved respirators meet the 

minimum requirements for subparagraph (a)(1) of this section: 
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(i) NIOSH-certified supplied-air respirator operated in pressure demand or other 

positive pressure mode and equipped with a tight-fitting full facepiece with an assigned 

protection factor of 75 . 

(3) Physical Form. The following forms of airborne chemical substances are listed for 

subparagraphs (a)(1) of this section: 

(i) Vapor. . 

(ii) Gas. 

(b) Low Concentrations in Mixtures. If the PMN substance is present in the work area only as a 

mixture, the Company is exempt from the provisions of this protection in the workplace section 

if the concentration of the PMN substance in the mixture does not exceed 1 .0 percent by weight 

or volume, or 0.1 percent by weight or volume if paragraph (g) of the Hazard Communication 

Program section of this Order identifies cancer as a potential human health hazard of the PMN 

substance. This exemption does not apply if the Company has reason to believe that during 

intended use or processing in the work area, the PMN substance in the mixture may be 

reconcentrated above the 1 .0 or 0.1 percent level, whichever is applicable. 

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. 
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(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 monitoring results in accordance with this New Chemical Exposure 

Limit section; and 

(iii) based on those monitoring results, select, provide, and ensure use 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 monitoring conducted in accordance with this New Chemical Exposure 

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). 
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(b) Exposure Limit. 

(1) General. The following new chemical exposure limit (NCEL) for the PNIN 

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 PNIN 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 PNIN substance in excess of 0.5 mg/m3 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 equal the 8-hour TWA in paragraph (i) 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, the 

Occupational Safety and Health Administration (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 PNIN 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 this Consent Order are not 

negated by any pre-existing OSHA PEL applicable to the PMN substance . 
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(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 

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), and (9). 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: "NCEL Sampling 

and Analytical Method for PMN # ," after-which the correct PNIN number for this chemical 

substance shall be stated . 

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

(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). 
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(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 . [Certain provisions of the TSCA GLPS applicable to 

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

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

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

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

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

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 
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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 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)(11) shall be evaluated using a two-sample t-test with unequal variances, 
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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 

average of each set of six samples must be within 10% of the true value. If the average of each 

set of six samples is not within 10% of the true value, then the sample storage time between 

collection and analysis must be reduced until the average of each set of six samples is within 

10% of the true value. 

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

following: 

(i) General. The sampling and analytical method, and all 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 limit ("LQL") of one half the NCEL to an upper quantitation limit ("UQL") of at 

least twice the NCEL. If the Company obtains a 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 Ouantitation Limit Sijznal-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 
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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. (A) For method development and validation (but 

not subsequent 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). (B) During each week of both method development/validation and 

subsequent monitoring, the Company shall conduct both an initial instrument calibration and a 

continuing calibration. The Company shall perform at least one continuing calibration sample at 

the NCEL concentration, and at least one additional calibration sample per every 10 samples 

analyzed. The continuing calibration sample shall fall within + 25% of the initial calibration 

value. 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. (A) 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 
-17- 

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. (B) 

During each subsequent 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 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% mustbe obtained for each of the six samples. 
-18-

(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 Accuracv 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 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 

presence of other chemicals, lighting, humidity, 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 
-19-

(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 lightsensitive 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) ComparabiliW. 

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 monitoring data. The Company is ultimately responsible for 

ensuring the validity of its monitoring data. 

(d) Monitoring Potential Ex op sure. 

(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) . (The action level may be exceeded without penalty; its 

purpose pertains solely to determination of the requisite monitoring frequency.) 

(ii) Representative Exposure Groups. Whenever 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 
-20- 

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 

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

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

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

inapplicable to the NCEL "requirements.] However, compliance with TSCA GLPS is not 

required where 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) 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 
-21- 

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 monitoring reveal an 

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

repeat the 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 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 6 month period does not constitute grounds for postponement 

of the 6 month deadline to conduct monitoring. 

(ii) If any representative samples taken during the initial monitoring reveal an 

airborne concentration above the TWA, the Company shall repeat the 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 

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 

monitoring. 

(iii) The Company may alter the 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 
-22-

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 monitoring reveal an 

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

exposure group, except when additional 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 monitoring 

followed by any periodic or additional monitoring required by subsection (d) of this New 

Chemical Exposure Limit section: 
-23-

(a) change in the production volume, process, control equipment, 

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

substance; 

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

cause new or additional exposures to the PMN substance; and 

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

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

(ii) In no event is the additional monitoring requirement in paragraph (d)(5)(i) 

intended to delay implementation of any necessary cleanup or other remedial action. During any 

such operations that may occur before commencing additional 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 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 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 
-24-

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 (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 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 
p. 33 
-25- 

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 in accordance with 29 CFR 1910.134 and 42 CFR Part 84. When the 

Company has not yet actually 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. 

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

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 P1Vl.N substance by inhalation use at least the respiratory protection which corresponds in 

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

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

GAS/VAPOR RESPIRATOR TABLE 

Measured 

Concentration 

of PMN Substance 

<_ NCEL 

<_ 10 x NCEL 

Reguired Respiratory Protection 

~ No respiratory protection is required. 

IfData on Cartridge Service Life Testing has been Reviewed and 

Approved bv EPA: 

~ NIOSH-certified air-purifying, tight-fitting full-face respirator 

equipped with the appropriate gas/vapor cartridges (organic vapor, acid 

gas, or substance-specific). 
-26-

" NIOSH-certified powered air-purifying respirator equipped with a 

loose fitting hood or helmet and equipped with the appropriate gas/vapor 

cartridges (organic vapor, acid gas, or substance-specific). 

_< 25 x NCEL IfData on Cartridge Service Life Testing has been Reviewed and 

Approved by EPA: 

" NIOSH-certified air-purifying, tight-fitting full-face respirator 

equipped with the appropriate gas/vapor cartridges (organic vapor, acid 

gas, or substance-specific). 

" NIOSH-certified powered air-purifying respirator equipped with a . 

loose-fitting hood or helmet and the appropriate gas/vapor cartridges 

(organic vapor, acid gas, or substance-specific). 

5 50 x NCEL Data on Cartrid, 

AppYoved by EPA: 

" NIOSH-certified air-purifying, tight-fitting full-face respirator 

equipped with the appropriate gas/vapor cartridges (organic vapor, acid 

gas, or substance-specific). 

IfNo Cartridge Service Life Testing is Available: 

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

continuous flow mode and equipped with a tight-fitting full facepiece. 

S 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 . 
p. 36 
-27- 

> 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 monitoring conducted at a workplace in accordance 

with subsection (d) of this New Chemical Exposure Limit section, the Company shall not, at that 

workplace, use the respiratory protection required by the Protection in the Workplace section of 

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

Before the Company may make any reduction in any respiratory protection selected pursuant to 

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

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

accordance with paragraph (e)(2) . Where 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 
-28-

accepted statistical methods . If the Company obtains a 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 19C supplied-air respirator listed in this subsection 

(e). 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 monitoring (as discussed in 

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

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

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

professional judgment of a qualified expert. 

(f) NCEL Record-keeping. 

(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); 
-29-

(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 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; . 

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

(vii) Notification of monitoring results required by paragraph (d)(8) ; 

(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; 
-30- 

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

communication program, including an existing program established under the Occupational 

Safety and Health Administration (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) 
-31-

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 nonroutine 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. 

(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: 

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

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

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

recognized. 
-32-

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

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

substance. 

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

identified in paragraph (g) 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 P1V1N 

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

use of the employee who performs the transfer. 

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

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: 

(A) The information prescribed in subparagraph (b)(1)(i) of this section. 
-33- 

(B) 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 Occupational Safety 

and Health Administration (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 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) . 
-34-

(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 are claimed confidential, a generic chemical name must be 

used. 

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

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

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

potential for fire, explosion; and reactivity . 

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

(g) 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. 
-35-

(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. 

(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 
-36-

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 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. 
p. 47 
-37- 

(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 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 (g) of this section. 

(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. 
-38-

(e) Low Concentrations in Mixtures. If the PMN substance is present in the work area only as a 

mixture, the Company is exempt from the provisions of this section if the concentration of the 

PMN substance in the mixture does not exceed 1 .0 percent by weight or volume, or 0.1 percent 

by weight or volume if paragraph (g) of this section identifies cancer as a potential human health 

hazard of the PMN substance. However; this exemption does not apply if the Company has 

reason to believe that during intended use or processing in the work area, the PMN substance in 

the mixture may be reconcentrated above the 1 .0 or 0.1 percent level, whichever is applicable . 

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

existing programs and procedures satisfy the requirements of this section. 

(g) 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) internal organ effects. 

(ii) reproductive effects. 

(iii) cancer . 

(iv) developmental effects. 

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

(i) avoid breathing the substance. 

(ii) avoid ingestion. 
-39-

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

or below an 8-hour time-weighted average of 0.5 Mg/M3 

(3) The human 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." 

MANUFACTURING 

(a)(1) The Company shall not cause, encourage, or suggest the manufacture or import of the 

PMN substance by any other person. 

(2) Sunset Following SNUR. Subparagraph (a)(1) shall expire 75 days after 

promulgation of a final significant new use rule ("SNUR") governing the PMN substance under 

section 5(a)(2) of TSCA unless the Company is notified on or before that day of an action in a 

Federal Court seeking judicial review of the SNUR. If the Company is so notified, 

subparagraph (a)(1) shall not expire until EPA notifies the Company in writing that all Federal 

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

(3) Notice of SNUR. When EPA promulgates a final SNUR for the PMN substance and 

subparagraph (a)(1) expires in accordance with subparagraph (a)(2), the Company shall notify 

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

substance of the existence of the SNUR. 

USE 

(a) The Company shall not use the PMN substance other than as a chemical intermediate for a 

herbicide. 
-40-

DISTRIBUTION 

(a) Distribution Requirements. Except as provided in paragraph (b), the Company shall . 

distribute the PMN substance outside the Company, including for disposal, only to a person who 

has agreed in writing prior to the date of distribution, to : 

(1) Not further distribute the PMN substance to any other person, including for disposal, 

until after the PMN substance has been completely reacted (cured). , 

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

Company in the Protection in the Workplace and the New Chemical Exposure Limit sections of 

this Order. 

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

Company in the Hazard Communication Program section of this Order. 

(4) Not use the PMN substance other than as a chemical intermediate for a herbicide. 

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

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

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

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

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

the PMN substance may be distributed only to the Company or a person who has given the 

Company the written agreement required by paragraph (a). 

(2) Any human exposure or environmental release resulting from opening the sealed 

containers and removing or washing out the PMN substance may occur only while the PMN 
-41-

substance is in the possession and control of the Company or a person who has given the 

Company the written agreement required by paragraph (a) . , 

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

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

to comply with any of the conditions specified in paragraph (a) of this Distribution section or, 

after paragraph (a)(1) expires in accordance with subparagraph (d)(1), has engaged in a 

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

submitting a significant new use notice to EPA, the Company shall cease supplying the 

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

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

the recipient has failed to comply with any of the conditions specified in paragraph (a) of this 

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

submitting a significant new use notice to EPA. 

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

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

aware of the terms of paragraph (a) of this Distribution section and will comply with those 

terms, or is aware of the terms of the significant new use rule for the PMN substance and will 

not engage in a significant new use without submitting a significant new use notice to EPA. 

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

(c)(2) of this Distribution section, the Company obtains knowledge that the recipient has failed 

to comply with any of the conditions specified in paragraph (a) of this Distribution section, or 

has engaged in a significant new use of the PMN substance without submitting a significant new 
-42-

use notice to EPA, the Company shall cease supplying the PNIN substance to that recipient, shall 

notify EPA of the failure to comply, and shall resume supplying the PMN substance to that 

recipient only upon written notification from the Agency. 

(d) Sunset Following SNUR. (1) Paragraph (a)(1) of this Distribution section shall expire 75 

days after promulgation of a final SNUR for the PMN substance under section 5(a)(2) of TSCA, 

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

judicial review of the SNUR. If the Company is so notified, paragraph (a)(1) of this Distribution 

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

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

(2) When EPA promulgates a final SNUR for the PMN substance and paragraph (a)(1) 

of this Distribution section expires in accordance with subparagraph (d)(1), the Company shall 

notify each person to whom it distributes the PNIN substance of the existence of the SNUR. 

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

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

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

the SNUR for this PMN substance in either the Federal Register or the Code of Federal 

Regulations. After promulgation of a SNUR and expiration of subparagraph (a)(1), such notice 

may substitute for the written agreement required in the introductory clause of paragraph (a); so 

that, if the Company provides such notice to the persons to whom it distributes the PMN 

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

specified in paragraph (a). 
-43-

Il . RECORD-KEEPING 

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

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

section 11 of TSCA: 

(1) Records documenting the manufacture and importation volume of the PMN 

substance and the corresponding dates of manufacture and import ; 

(2) Records documenting volumes of the substance purchased in the United States by 

processors of the substance, names and addresses of suppliers and corresponding dates of 

purchase. 

(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; 

(5) Records required by paragraph F. of the New Chemical Exposure Limits section of 

this Order, if applicable ; 

(6) Records documenting establishment and implementation of the hazard 

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

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

Order; 

(8) Copies of material safety data sheets required by the Hazard Communication 

Program section of this Order; 
-44-

(9) Records documenting compliance with any applicable manufacturing, use, and 

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

including distributees' written agreement to comply with the Distribution 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, imported, processed or used. 

(b) Applicability. The provisions of this Record-keeping 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. 

III. 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 
-45-

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 is not required to submit a new PMN to EPA. 

(c) Definitions. The following definitions apply to this Successor Liability section of the Order: 

(1) "Successor in Interest" means a person outside the Company who has acquired the 

Company's full interest in the rights to manufacture 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(3) . 
-46-

(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. 

(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 and time 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 and time of the transfer described above. 
-47-

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

Order effective as of the date and time 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. 

IV. 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 
-48-

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 . 
-49-

V. EFFECT OF CONSENT ORDER 

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, does 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 TS CA. 

Date Wardner G. Penberthy, Xcting Director 

Chemical Control Division 

Office of Pollution Prevention and Toxics 

5 

Date 

Company: 

Name: ~-/~, t~(/ ~I117v 

Title: 
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 International Union of Pure and Applied 

Chemistry or 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. 
-2- 

"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 

labelled 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 

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, nor 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. 
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 

Si2 = E(X;j - X;)2/(n ; - 1), i=1, 2 

Form the ratio 

T = (XI - X2)/(WI + Wz)vz 

Compute degrees of freedom 

f= (Wl + WZ)2/[WlZ/(nl - 1) + W22/(n2 

- 1)] 

where, 

W,=S12/n,,i=1,2 

X1= Average of the results from the company laboratory 

X2= Average of the results from the independent laboratory 

n, = Number of samples analyzed by the company laboratory 

n2= Number of samples analyzed by the independent laboratory . 
-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 a 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 n,=6 X2=100.40~ n2=6 

S1' = 278 .72 W1=46.25 S22 = 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 
-3- 

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

S1' = 65.59 Wl = 10 .93 S22 

= 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. 
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. Assuamption 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(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. 
-2- 

TOXIC SUBSTANCES CONTROL ACT 

SECTION S(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

Company (Transferor) PNIN 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 
-3- 

Successor's Technical Contact 

TOXIC SUBSTANCES CONTROL ACT 

SECTION 5(e) CONSENT ORDER 

NOTICE OF TRANSFER 

(continued) 

City, State, Zip Code 

Phone 
p. 70