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BUSINESS INFORMATION 

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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: 

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Consent Order and Determinations Supporting Consent Order 
-11-

TABLE OF CONTENTS 

Preamble 

I. Introduction 

IT. Summary of Terms of the Order 

ill. Contents of PMN 

IV. EPA's Assessment of Exposure and Risk 

V. EPA's Conclusions of Law 

VI. Information Required to Evaluate Human Health 

Consent Order 

I. Scope of Applicability and Exemptions 

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

Pending Submission and Evaluation of Information 

ill. Record-keeping 

IV. Requests for Pre-Inspection Information 

V. Successor Liability Upon Transfer of Consent Order 

VI. Modification and Revocation of Consent Order 

VII. Effect of Consent Order 

Attachment A Definitions 

Attachment B- Statistical Analysis of NCELs Analytical Method Verification Results 

Attachment C - Notice of Transfer of Consent Order 
-mPREAMBLE 

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") P04-834 for the chemical substance [ 

] (the "PMN substance") submitted by Arch 

Chemicals ("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 certain toxicity testing at least 14 weeks before manufacturing or importing a total of 

[ ] kilograms (Tier I) and [ ] (Tier m of the PMN substance; 

(2) provide personal protective equipment to its workers to prevent dermal exposure; 
-IV-

(3) provide respirators with a minimum Assigned Protection Factor (APF) of 25 to its workers to 

prevent inhalation exposure; 

(4) 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 0.05 mg/m3 as an 8-

hour time-weighted average, verified by actual exposure monitoring data (To pursue this option, a 

sampling and analytical method must be developed by the Company, verified by an independent thirdparty laboratory, and submitted to EPA.); 

(5 ) label containers of the PMN substance and provide Material Safety Data Sheets (MSDSs) and 

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

(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. 

III. CONTENTS OF PMN 

Confidential Business Information Claims (Bracketed in the Preamble and Order): Chemical identity, 

production volume, other information 

Chemical Identity: 

Specific: [ 

Generic: HDI Biuret, hydroxyethyl methacrylate prepolymer 
-vUse: As an ingredient in 2-component polyurethane coatings 

Maximum 12-Month Production Volume: [ ] kg/year 

Test Data Submitted with PMN: none 

IV. EPA'S ASSESSMENT OF EXPOSURE AND RISK 

The following are EPA's predictions regarding the probable human toxicity of and exposure to 

the PMN substance, based on the information currently available to the Agency. 

Human Health Effects Summary: 

Toxicological Endpoints and Basis for Concern: The concerns for the PMN substance are potential 

dermal and respiratory sensitization and pulmonary toxicity and carcinogenicity from the PMN 

substance if inhaled. Based on conflicting animal and human data for respiratory sensitization, the 

Agency has determined that there is presently not a reliable animal model for testing diisocyanates for 

potential respiratory sensitization. At this time, it is assumed that all diisocyanates may be potential 

human respiratory sensitizers. See www.epa.gov/oppt/newchems/chemcat.htm 

Exposure and Environmental Release Summary: 

Manufacture Process Use 

#Sites Not Applicable (N/ A) NIA 50 

#of Workers with Exposure (Total) NIA N/A 1,000 

Exposure (days/year) N/A N/A 250 

Dermal Exposure N/A N/A 1,700 (liquid at 20% PMN 

(mglday) concentration) 

Inhalation Exposure NIA N/A 48 (worst-case) 

(mglday) 0.2 (typical) 

Drinking Water Exposure N/A N/A .00405 

(mglday/day) 
-VlRisk to Workers: 

Based on Structural Activity Relaionship (SAR) analysis derived from test data on structurally 

similar diisocyanates, there is a risk to workers for dermal and pulmonary sensitization and irritation and 

possible pulmonary toxicity and carcinogenicity from the PMN substance if inhaled. 

NIOSH Assigned Protection Factor (APF): 

New Chemical Exposure Limit: 0.05 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 pulmonary sensitization and irritation in addition to 

possible pulmonary carcinogenicity from exposure of humans to the PMN substance. EPA therefore 

concludes, pursuant to § 5( e )(1 )(A)(i) of TSCA, that the information available to the Agency is 

insufficient to permit a reasoned evaluation of the human health effects of the PMN substance. 

(b) In light of the potential risk of pulmonary sensitization and irritation in addition to possible 

pulmonary carcinogenicity posed by the uncontrolled manufacture, import, processing, distribution in 

commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 

5(e)(l)(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. 
(c) In light of the estimated production volume of, and human exposure to, the PMN substance, EPA 

has further concluded, pursuant to§ 5(e)(l)(A)(ii)(II) of TSCA, that the PMN substance will be 

produced in substantial quantities and there may be significant (or substantial) human exposure to the 

substance. 

VI. INFORMATION REQUIRED TO EVALUATE HUMAN HEALTH EFFECTS 

Triggered Testing. The Order prohibits the Company from exceeding a specified production 

volume unless the Company submits the information described in the Testing section of this Order in 

accordance with the conditions specified in the Testing section. 
CONSENT ORDER 

I. SCOPE OF APPLICABILITY AND EXEMPTIONS 

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

distribution in commerce, use and disposal of the chemical substance [ 

] 

(P04-834) ("the PMN substance") in the United States by Arch Chemicals Inc.("the Company"), 

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

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

substance is exempt from the requirements of this Order (except the requirements in the Recordkeeping 

and Successor Liability Upon Transfer Of Consent Order sections) only to the extent that (1) these 

activities are conducted in full compliance with all applicable requirements of the following exemptions, 

and (2) such compliance is documented by appropriate recordkeeping as required in the 

Recordkeeping section of this Order. 

( 1) Completely Reacted (Cured). The requirements of this Order do not apply to quantities of 

the PMN substance that have been completely reacted (cured). 
2 

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

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

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

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

this Order). This exemption is not available if the Company has reason to believe that, during intended 

activities, the PMN substance in the mixture may be reconcentrated above the 1.0 or 0.1 percent level, 

whichever applies. 

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

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

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

40 CFR 720.3(s). However, once the Company begins to manufacture the PMN substance for use in 

the United States, no further activity by the Company involving the PMN substance is exempt as "solely 

for export" even if some amount of the PMN substance is later exported. At that point, the 

requirements of this Order apply to all activities associated with the PMN substance while in the 

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

PMN substance that are destined for export are subject to terms of the Order, and count towards any 

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

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

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

quantities solely for research and development in accordance with TSCA §5(h)(3), 40 CFR 720.3(cc), 

and 40 CFR 720.36. 
3 

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

produced, without separate commercial intent, only as a "byproduct" as defined at 40 CFR 720.3(d) 

and in compliance with 40 CFR 720.30(g). 

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

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

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

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

(TME) under TSCA §5(h)(l) and 40 CFR 720.38 or a Low Volume Exemption (LVE) or Low 

Release and Exposure Exemption (LoREX) under TSCA §5(h)(4) and 40 CFR 723.50(c)(l) and (2) 

respectively, any such exemption is automatically rendered null and void as of the effective date of this 

Consent Order. 

II. TERMS OF MANUFACTURE. IMPORT. PROCESSING, 

DISTRIBUTION IN COMMERCE, USE, AND DISPOSAL 

PENDING SUBMISSION AND EVALUATION 

OF INFORMATION 

PROHIBITION 

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

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

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

the human health effects of the substance, and the completion of EPA's review of, and regulatory action 
4 

based on, that information, except in accordance with the conditions described in this Order. 

TESTING 

(a) Section 8(e) Reporting. Reports of information on the PMN substance which reasonably supports 

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

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

11110 (March 16, 1978), 68 Federal Register 33129 (June 3, 2003), and 70 Federal Register 2162 

(January 12, 2005), shall reference the appropriate PMN identification number for this substance and 

contain a 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 56 

Federal Register 28458 (June 20, 1991). 

(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; 

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

may contact regarding the study; and 
5 

( 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 in the relevant scientific community at 

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

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

within 4 weeks of receiving the written protocols. Published test guidelines specified in paragraph (d) 

provide general guidance for development of test protocols, but are not themselves acceptable 

protocols. EPA approval of a test protocol does not mean pre-acceptance of test results. 

(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 PMN substance and submits all final 

reports and underlying data in accordance with the conditions specified in this Testing section. 

Production Limit (kilograms) 

Tier 1: [ ] 

Tier II: [ ] 

Dermal sensitization test 

90-day subchronic inhalation 

Toxicity test in rodents 

Guideline 

(OPPTS 

870.2600) 

(OPPTS 

870.3465) 
6 

(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 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 writing by EPA that it is unnecessary to conduct that study. 

(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 under the conditions specified in 
7 

paragraphs (b), (c), and (e)(l) 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)(l) 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. 

(ii) The Company may, within 4 weeks of receiving from EPA the notice described in 
8 

subparagraph (h)(l), 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 in 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 
9 

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 (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: 

(A) within 2 weeks from receipt of the notice described in subparagraph (j)(l), the Company 

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

(B) within 4 weeks from receipt of the notice described in subparagraph (j)(l), 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 
10 

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 N. of this Consent 

Order. 

PROTECTION IN THE WORKPLACE 

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

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

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

establish a program whereby: 

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

in the work area to the PMN substance through direct handling of the substance or through contact 

with equipment on which the substance may exist, or because the substance becomes airborne in a 

form listed in subparagraph (a)(5) of this section, is provided with, and is required to wear, personal 

protective equipment that provides a barrier to prevent dermal exposure to the substance in the specific 

work area where it is selected for use. Each such item of personal protective equipment must be 
11 

selected and used in accordance with OSHA dermal protection requirements at 29 CFR 1910.132, 

1910.133, and 1910.138. 

(2) Specific Dermal Protective Equipment. The dermal protective equipment required by 

subparagraph (a)(l) of this section must include, but is not limited to, the following items are required: 

(i) Gloves. 

(ii) Full body chemical protective clothing. 

(iii) Chemical goggles or equivalent eye protection. 

(iv) Clothing which covers any other exposed areas of the arms, legs and torso. 

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

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

dermal exposure during normal and expected duration and conditions of exposure within the work area 

by any one or a combination of the following: 

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

clothing and the construction of the clothing to establish that the protective clothing will be impervious 

for the expected duration and conditions of exposure. The testing must subject the chemical protective 

clothing to the expected conditions of exposure, including the likely combinations of chemical 

substances to which the clothing may be exposed in the work area. Permeation testing shall be 

conducted according to the American Society for Testing and Materials (ASTM) F739 "Standard Test 

Method for Resistance of Protective Clothing Materials to Permeation by Liquids or Gases." Results 

shall be reported as the cumulative permeation rate as a function of time, and shall be documented in 

accordance with ASTM F739 using the format specified in ASTM Fll94-89 "Guide for Documenting 
12 

the Results of Chemical Permeation Testing on Protective Clothing Materials." Gloves may not be used 

for a time period longer than they are actually tested and must be replaced at the end of each work shift 

during which they are exposed to the PMN substance. 

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

or supplier of the chemical protective clothing, or of the material used in construction of the clothing, to 

establish that the chemical protective clothing will be impervious to the PMN substance alone and in 

likely combination with other chemical substances in the work area. 

(4) 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)(5) of this section, is 

provided with, and is required to wear, at a minimum, a NIOSH-certified Category I respirator 

(Assigned Protection Factor 2 25), from the respirators listed in subparagraph (a)(6) of this section, 

and the respirator is used in accordance with OSHA and NIOSH respiratory protection requirements 

at 29 CFR 1910.134 and 42 CFR Part 84. All respirators must be issued, used, and maintained 

according to an appropriate respiratory protection program under the Occupational Safety and Health 

Administration (OSHA) requirements in 29 CFR 1910.134. 

(5)Physical States. The following physical states of airborne chemical substances are listed for 

subparagraphs (a)(l) and (4) of this section: 

(i) Combination GasNapor and Particulate (gas and liquid/solid physical states are both 

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

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

requirements for subparagraph (a)(4) of this section: 
13 

!{Data on Cartridge Service Lite Testing has been Reviewed and Approved by 

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

the appropriate combination cartridges. Cartridges should be tested and approved for the gas/vapor 

substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and should include a 

particulate filter (NlOO if oil aerosols are absent, RIOO, or PlOO). 

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

fitting hood or helmet and the appropriate combination cartridges. Cartridges should be tested and 

approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) 

and should include HEP A filters. 

(III) NIOSH-certified powered air-purifying respirator equipped with a tightfitting facepiece (full-face) and the appropriate combination cartridges. Cartridges should be tested and 

approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) 

and should include HEP A filters. 

(IV) NIOSH-certified supplied-air respirator operated in pressure demand or 

continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (full-face). 

!{No Cartridge Service Life Testing is Available: 

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

continuous flow mode and equipped with a hood or helmet, or tight-fitting facepiece (full-face). 

NEW CHEMICAL EXPOSURE LIMIT 

(a) Alternative to Requirements of Respirator Section. 
14 

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

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

exposures whenever practicable. 

(2) Whenever a person is reasonably likely to be exposed to the PMN substance by inhalation, 

as an alternative to compliance with the respirator requirements in the Protection in the Workplace 

section of this Order, the Company may comply with the requirements of this New Chemical Exposure 

Limit section. However, before the Company may deviate from the respirator requirements in the 

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

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

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

section; 

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

Limit section; and 

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

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

Exposure Limit section by persons who are reasonably likely to be exposed to the PMN substance by 

inhalation. 

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

results of actual exposure monitoring conducted in accordance with this New Chemical Exposure 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 
15 

Chemical Exposure Limit section). 

(b) Exposure Limit. 

(1) General. The following new chemical exposure limit (NCEL) for the PMN substance is an 

interim level determined by EPA based on the limited information available to the Agency at the time of 

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

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

is exposed to an airborne concentration of the PMN substance in excess of 0.05 mg/m3 (the NCEL) as 

an 8-hour time-weighted average, without using a respirator in accordance with subsection (e) of this 

New Chemical Exposure Limit section. 

(ii) Non-8-Hour Work-shifts. For non-8-hour work-shifts, the NCEL for that workshift (NCELn) shall be determined by the following equation: NCELn = NCEL x (8/n) x [(24-n)/16], 

where n =the number of hours in the actual work-shift. 

(2) Automatic Sunset. If, subsequent to the effective date of this Order, 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 PMN substance and the OSHA PEL is not challenged in court within 60 days of its 

promulgation, then any respirator requirements in the Protection in the Workplace section of this Order 

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

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

requirements of this Consent Order are not negated by any pre-existing OSHA PEL applicable to the 
16 

PMN substance. 

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

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

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

monitoring conducted pursuant to subsection (d) of this New Chemical Exposure Limit section, only the 

following requirements apply: (c)(4)(i), (4)(ii), (4)(iv)(B), (4)(v)(B), (8), 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 of the first page: "NCEL Sampling and Analytical Method for PMN # P04-

834," after-which the correct PMN number for this chemical substance shall be stated. 

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

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

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

the other requirements in this subsection (c)(3). It is the Company's responsibility to ensure that the 
17 

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

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

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

person who may have developed the method for the Company. 

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

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

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

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

Standards (GLPS) at 40 CFR Part 792. [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 
18 

the same time, and under the same conditions. One set of six samples shall immediately be analyzed by 

the Company, the other set of six samples shall be analyzed by the Laboratory using the method 

developed by or for the Company. 

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

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

perform a sample storage study as follows: 

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

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

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

solids and liquids with very low vapor pressure, by injecting the PMN substance onto a sample 

collection device. The triplicate samples shall be collected on identical collection media, at the same 

time, and under the same conditions. One set of six samples shall immediately be analyzed by the 

Company. 

(ll) 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 
19 

samples analyzed by the Laboratory and the Company as required in either paragraph (c)(3)(v) or 

(c)(3)(vi)(ll) shall be evaluated using a two-sample t-test with unequal variances, and the two sides of 

the critical regions shall not exceed a 5% significance level. (See Attachment B - Statistical Analysis of 

NCELs Analytical Method Verification Results.) The 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 exposure monitoring data 

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

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

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

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

analytical method must be capable of reliably quantifying from a lower quantitation limit ("LQL") of one 

half the NCEL to an upper quantitation limit ("UQL") of at least twice the NCEL. If the Company 

obtains an exposure monitoring sample that is more than 10% above the actual UQL of the analytical 

method, the Company must comply with paragraph (e)( 4 )(i). 

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

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

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

possible, even if the required amplification is beyond that used in routine analysis of samples. (If 
20 

baseline noise cannot be obtained, another reference must be selected. This may be a peak considered 

to be noise caused by the reagent matrix.) The sampling preparation method must be specified and the 

detection limit for the analytical procedure must be reported as mass per injection for chromatographic 

techniques. 

(iv) Instrument Calibration. 

(I) Initial Calibration. For method development and validation (but not 

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

standards with a linear correlation of 0.95 -- these five (5) calibration standards must consist of one 

standard at each of the following concentrations: one half the NCEL (0.5 x NCEL); between one half 

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

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

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

development/validation and subsequent exposure monitoring, the Company shall conduct both an initial 

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

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

10 samples analyzed. The continuing calibration sample shall fall within± 25% of the initial calibration 

value. If not, then the initial calibration must be repeated, and any samples associated with that outlying 

calibration check must be re-analyzed. 

(v) Calculated Percent Recovery. 

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

must calculate the percent of the PMN substance recovered by the analytical method from a sample 
21 

containing a known quantity of the PMN substance. The sample shall be taken either from a controlled 

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

conditions or, for solids and liquids with very low vapor pressure, by injecting the PMN substance onto 

a sample collection device. (Such a sample is referred to as a "matrix spike"). The calculated percent 

recovery for each matrix spike shall be greater than or equal to 75% and less than or equal to 125%. 

Spike concentrations for the PMN substance must be included in the sampling and analytical method 

submitted to EPA. 

(II) Subsequent Calculation. During each subsequent exposure monitoring 

episode or campaign, at least 1 matrix spike, prepared by injecting the PMN substance onto a sample 

collection device, shall be analyzed. (This matrix spike must be prepared at the NCEL concentration.) 

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

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

capable of collecting the new chemical in solid, liquid or vapor phase with minimal loss. The sampling 

device's capacity (air volume and collected analyte mass) must be specified. For 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 
22 

PMN substance at least the NCEL concentration must be prepared. A recovery of at least 75% must 

be obtained for each of the six samples. 

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

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

0.1 05, including allowance of 0.05 for error due to sampling. 

(6) Interpretation of Accuracy and Precision Data. 

(i) If a single matrix spike recovery is less than 75% recovery or greater than 125% or 

the estimated precision is greater than 0.105, then the Company must re-prepare the matrix spike, resample, 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 temperature, 

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

be monitored. 

(8) Changes Affecting Validity. If the workplace environment changes from the initial 

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

invalidate the accuracy of the method, then the Company must comply with the respirator requirements 
23 

in the Protection in the Workplace section of this Order, unless the Company re-validates the method 

to confirm that the requirements for accuracy and precision in paragraphs (c)(4) and (5) are met. 

Examples of possible changes include but are not limited to: introduction of a new chemical substance 

to the workplace which may interfere with the analysis of the new chemical; introduction of light to the 

workplace which may interfere with a light-sensitive PMN substance; or introduction of 

water/increased humidity to the workplace which could react with the PMN substance and cause 

difficulties in collection and analysis. 

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

the NCEL. 

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

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

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

ensuring the validity of its exposure monitoring data. 

(d) Monitoring Potential Exposure. 

( 1) General. 

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

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

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

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

level without penalty. The purpose of the action level is solely to determine the requisite monitoring 
24 

frequency. 

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

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

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

the PMN substance would be if respirators were not worn. The Company shall do so by sampling the 

breathing zone air of at least one person that represents, and does not underestimate, the potential 

exposure of every person performing the same or substantially similar operations in each work shift, in 

each job classification, in each work area (hereinafter identified as an "exposure group") where 

inhalation exposure to the PMN substance is reasonably likely to occur. The exposure of each person 

need not be itself directly sampled if that exposure is represented by sampling the exposure of another 

person in the same exposure group. 

(iii) Good Laboratory Practice Standards. Determinations of potential inhalation exposure 

shall be made according to TSCA Good Laboratory Practice Standards at 40 CFR Part 792 and the 

sampling and analytical method developed pursuant to subsection (c) of this New 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 exposure monitoring samples are 

analyzed by a laboratory accredited by either: (A) the American Industrial Hygiene Association 

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

program approved in advance in writing by EPA. 
25 

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

shall be determined on the basis of samples representing the full shift exposure for each exposure group. 

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

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

accurately determine the airborne concentration of the PMN substance for each exposure group in 

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

(3) Periodic Monitoring. 

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

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

the exposure monitoring for that exposure group at least every 6 months. If the PMN substance is not 

manufactured, processed, or used at all during a given 6 month calendar period, the Company is not 

required to conduct exposure monitoring until manufacture, processing, or use of the PMN substance is 

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

than the 6 month period does not constitute grounds for postponement of the 6 month deadline to 

conduct exposure monitoring. 

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

airborne concentration above the TWA, the Company shall repeat the exposure monitoring for that 

exposure group at least every 3 months. If the PMN substance is not manufactured, processed, or 

used at all during a given 3 month calendar period, the Company is not required to conduct exposure 

monitoring until manufacture, processing, or use of the PMN substance is resumed. However, 
26 

cessation of manufacturing, processing and use of the PMN substance for less than the 3 month period 

does not constitute grounds for postponement of the 3 month deadline to conduct exposure monitoring. 

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

every 6 months for any exposure group for whom two consecutive measurements taken at least 7 days 

apart indicate that the potential exposure has decreased to the TWA or below, but is at or above the 

action level. Where the PMN substance is manufactured, processed, or used in batches of duration 

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

the measurements accurately reflect the highest peak exposures and variability in exposure. 

( 4) Termination of Monitoring. 

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

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

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

New Chemical Exposure Limit section. 

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

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

are below the action level, the Company may discontinue the monitoring for that exposure group, 

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

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

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

the measurements accurately reflect the highest peak exposures and variability in exposure. 
27 

(5) Additional Monitoring. 

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

any of the events listed below in this paragraph (d)(5)(i), conduct the initial exposure monitoring 

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

Chemical Exposure Limit section: 

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

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

em spills, leaks, ruptures or other breakdowns occur that may reasonably 

cause new or additional exposures to the PMN substance; and 

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

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

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

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

cleanup or remedial operations that may occur before commencing additional exposure monitoring, the 

Company shall ensure that potentially exposed persons use at least the respiratory protection specified 

in subsection (e) for the measured airborne concentration, or more protective respiratory equipment 

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

(6) Notification of Monitoring Results. 

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

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

monitoring. The notice shall identify the NCEL, the exposure monitoring results, and any corresponding 
28 

respiratory protection required by subsection (e). Affected persons shall be notified in writing either 

individually or by posting the information in an appropriate and accessible location. 

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

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

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

actions to be taken to reduce exposure. 

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

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

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

procedures and conditions for a specific "exposure group" (defined in paragraph (d)(l)(ii)), then that 

exposure group is exempt from this New Chemical Exposure Limit section (except paragraph (d)(5) 

"Additional Monitoring" and subsection (f) "NCEL 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. 
29 

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

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

airborne concentration of the PMN substance for any person who is reasonably likely to be exposed to 

the PMN substance by inhalation exceeds the NCEL, the Company shall provide those persons the 

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

Workplace section of this Order), and shall ensure that the respirators are used (including training, fit 

testing, and maintenance) in accordance with OSHA and NIOSH respiratory protection requirements 

at 29 CFR 1910.134 and 42 CFR Part 84. When the Company has not yet measured the airborne 

concentration of the PMN substance at a workplace in accordance with this New Chemical Exposure 

Limit section, the Company shall comply with the respirator requirements in the Protection in the 

Workplace section of this Order at that workplace. 

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

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

the Company shall select, provide, and ensure that persons who are reasonably likely to be exposed to 

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

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

corresponds to a concentration higher than measured). 

[(Data 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 

combination cartridges. Cartridges should be tested and approved for the gas/vapor substance 

(i.e., organic vapor, acid gas, or substance-specific cartridges) and should include a particulate 
30 

filter (NIOO if oil aerosols are absent, RIOO, or PIOO). 

,.. NIOSH-certified powered air-purifying respirator equipped with a loose fitting hood or 

helmet and the appropriate combination cartridges. Cartridges should be tested and approved 

for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific cartridges) and 

should include HEP A filters . 

... NIOSH-certified powered air-purifying respirator equipped with a tight-fitting facepiece 

(full-face) and the appropriate combination cartridges. Cartridges should be tested and 

approved for the gas/vapor substance (i.e., organic vapor, acid gas, or substance-specific 

cartridges) and should include HEP A filters. 

,.. NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow 

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

lfNo Cartridge Service Life Testing is Available: 

,.. NIOSH-certified supplied-air respirator operated in pressure demand or continuous flow 

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

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

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

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

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

Order (unless it is the same as required by this New Chemical Exposure Limit section). Before the 
31 

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 accepted statistical 

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

actual upper quantitation limit (UQL) of the analytical method, the Company must ensure that its 

workers wear at least a NIOSH-certified supplied-air respirator operated in pressure demand or other 

positive pressure mode and equipped with a tight-fitting full facepiece. Any reductions in this 

respiratory protection must comply with paragraph (e)(3). The Company may submit an improved 

analytical method provided that it complies fully with subsection (c) of this New Chemical Exposure 

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

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

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

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

protection specified above in this subsection (e) for the measured airborne concentration, or more 
32 

protective respiratory equipment deemed appropriate by the best professional judgment of a qualified 

expert. 

(f) NCEL Recordkeeping. 

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

rather than the respirator requirements in the Protection in the Workplace section of this Order, the 

Company shall maintain the following records until 30 years after the date they are created, and shall 

make them available for inspection and copying by EPA in accordance with section 11 of TSCA: 

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

accuracy over time as required by section (c); 

(ii) Records documenting compliance with the analytical method verification 

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

verification results obtained by both laboratories; 

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

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

Association (AlliA) 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 AlliA or the written approval from EPA. 

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

sample taken; 

(v) Records documenting the name, address, work shift, job classification, and work 
33 

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

represent; 

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

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

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

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

substance; 

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

cause new or additional exposure; 

substance; 

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

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

(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, 
34 

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) SNUR at 40 

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

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

under paragraph (c) of this section. The list may be compiled for the workplace or for individual work 

areas. If the Company is required either by another Order issued under section 5( e) of TSCA, or by a 

TSCA section 5(a)(2) SNUR at 40 CFR Part 721, subpart E, to maintain a list of substances, the lists 

shall be combined with the list under this subparagraph. 

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

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

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

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

substance in the Company's workplace and of the provisions of this Order if employees of the 
35 

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: 

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

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

(IT) The identity by which the PMN substance may be commonly recognized. 

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

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

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

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

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

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

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

conveys information specified by subparagraph (b )(I )(i) of this section. Any written materials must be 

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

(iii) The Company need not label portable containers into which the PMN substance is 

transferred from labeled containers, and which are intended only for the immediate use of the employee 
36 

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 relabeled with the information specified in subparagraph (b)( 1 )(i) of this section. 

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

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

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

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

(IT) 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 
37 

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). 

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

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

label within 3 months from the time the Company becomes aware of the new information. If the PMN 

substance is not being manufactured, imported, processed, or used in the Company's workplace, the 

Company must add the new information to the label before the PMN substance is reintroduced into the 

workplace. 

(c) Material Safety Data Sheets. 

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

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

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

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

and common name 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). 
38 

(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 (t) of this 

section. 

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

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

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

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

required by this Order, or alternative control measures which EPA has determined under 40 CFR 

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

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

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

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

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

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

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

spills and leaks. 

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

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

(x) Emergency first aid procedures known to the Company. 

(xi) The date of preparation of the MSDS or of its last revision. 
39 

(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 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. 
40 

(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. 

(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)( I) of 

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

(2) The training provided to employees shall include: 

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

PMN substance in or from an employee's work area (such as exposure monitoring conducted by the 
41 

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

released). 

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

specified in paragraph (f) of this section. 

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

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

and the environment from exposure to the PMN substance, including appropriate work practices, 

emergency procedures, personal protective equipment, engineering controls, and other measures to 

control worker exposure and/or environmental release required under this Order, or alternative control 

measures which EPA has determined under 40 CFR 721.30 provide the same degree of protection as 

the specified control measures. 

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

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

this section and guidance on obtaining and using appropriate hazard information. 

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

existing programs and procedures satisfy the requirements of this section. 

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

human health and environmental hazard and precautionary statements shall appear on each label as 

specified in paragraph (b) and the MSDS as specified in paragraph (c) of this section: 
42 

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

(i) skin irritation. 

(ii) respiratory complications. 

(iii) cancer. 

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

(i) avoid skin contact. 

(ii) avoid breathing the substance. 

(iii) avoid ingestion. 

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

below an 8-hour time-weighted average of 0.05 mglm3

• 

(v) use skin protection. 

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

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

details." 

MANUFACTURING 

(a)(l) Prohibition. 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)(l) 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 
43 

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)(l) 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)(l) 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. 

DISTRIBUTION 

(a) Distribution Requirements. Except after the PMN has been completely reacted (cured), or as 

provided in subparagraph (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. 

(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 
44 

(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 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)(l) expires in accordance with subparagraph (d)(l), 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. 
45 

(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 use notice to EPA, the 

Company shall cease supplying the PMN 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)(l) 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. Ifthe Company is so notified, paragraph (a)(l) 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)(l) of this 

Distribution section expires in accordance with subparagraph (d)(l), the Company shall notify each 
46 

person to whom it distributes the PMN 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)(l), 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). 

III. RECORDKEEPING 

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

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

11 ofTSCA: 

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

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

satisfy all the statutory and regulatory recordkeeping requirements applicable to the exemption being 

claimed by the Company. Any amounts or batches of the PMN substance eligible for the export only 

exemption in Section I, Paragraph (b)(3) of this Order, are exempt from all the requirements in this 

Recordkeeping section, if the Company maintains, for 5 years from the date of their creation, copies of 

the export label and export notice to EPA, required by TSCA sections 12(a)(l)(B) and 12(b), 
47 

respectively. Any amounts or batches of the PMN substance eligible for the research and development 

exemption in Section I, Paragraph (b)( 4) of this Order, are exempt from all the requirements in this 

Recordkeeping section, if the Company maintains, for 5 years from the date of their creation, the 

records required by 40 CFR 720.78(b). For any amounts or batches of the PMN substance claimed 

to be eligible for any other exemption described in Section I, Paragraph (b) of this Order, the Company 

shall keep records demonstrating qualification for that exemption as well as the records specified in 

paragraphs (2) and (3) below, but is exempt from the other recordkeeping requirements in this 

Recordkeeping section; 

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

the corresponding dates of manufacture and import; 

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

different) of all persons outside the site of manufacture or import to whom the Company directly sells or 

transfers the PMN substance, the date of each sale or transfer, and the quantity of the substance sold or 

transferred on such date; 

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

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

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

of this Order; 

(6) Records documenting the determinations required by the Protection in the Workplace 

section of this Order that chemical protective clothing is impervious to the PMN substance; 

(7) Records required by paragraph (f). of the New Chemical Exposure Limits section of this 
48 

Order, if applicable; 

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

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

(9) Copies of labels required under the Hazard Communication Program section of this Order; 

( 1 0) Copies of material safety data sheets required by the Hazard Communication Program 

section of this Order; 

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

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

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

(12) Records documenting compliance with any applicable disposal requirements under the 

Disposal section of this Order, including method of disposal, location of disposal sites, dates of 

disposal, and volume of PMN substance disposed. Where the estimated disposal volume is not 

known to the Company and is not reasonably ascertainable by the Company, the Company must 

maintain other records which demonstrate establishment and implementation of a program that ensures 

compliance with any applicable disposal requirements; 

(13) Records documenting establishment and implementation of procedures that ensure 

compliance with any applicable water discharge limitation in the Release to Water section of this Order; 

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

section of this Order, if applicable; and 

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

substance is manufactured or imported. 
49 

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

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

customers. 

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

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

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

and Budget (OMB), and EPA so informs the Company. The "collection of information" required in this 

TSCA §5(e) Consent Order has been approved under currently valid OMB Control Number 2070-

0012. 

IV. REQUESTS FOR PRE-INSPECTION INFORMATION 

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

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

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

advance to request information pertinent to the scheduling and conduct of such inspections. Such 

requests may be written or oral. The types of information that EPA may request may include, but are 

not limited to, the following: 

(i) Expected dates and times when the PMN substance will be in production within the 

subsequent 12 months; 
50 

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

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

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

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

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

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

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

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

conducting an inspection for that purpose. 

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

time, but in no event later than 30 days after receiving EPA's request. When requested in writing by 

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

.reasonably ascertainable by the Company at the time of the request, the Company's response shall 

demonstrate a good faith effort to provide reasonably accurate and detailed answers to all of EPA's 

requests. 

(c) Confidential Business Information. Any Confidential Business Information (CBI) that the Company 

submits to EPA pursuant to paragraph (b) shall be protected in accordance with § 14 of TSCA and 40 

CFR Part 2. 
51 

V. SUCCESSOR LIABILITY UPON TRANSFER OF CONSENT ORDER 

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

this Order may be transferred when the Company transfers its interests in the PMN subst;mce, 

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)(l) ofTSCA and 40 CFR part 720 before 

commencing manufacture or import of the PMN substance. 

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

EPA receives a NOC, the Successor in Interest shall comply with the terms of this Order and shall not 

be required to submit a new PMN to EPA 

(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 
52 

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 CPR 

720.22(a)(3). 

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

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

in Interest. 

(d) Notices. 

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

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

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

Order. 

(2) Notice to EPA. Within 10 business days of the effective date of the transfer, the Company 

shall, by registered mail, submit the fully executed Notice of Transfer document to: U.S. Environmental 

Protection Agency, New Chemicals Branch (7405), 1200 Pennsylvania Avenue, N.W., Washington, 

D.C. 20460. 

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

Successor in Interest at its principal place of business, and at all sites where the PMN substance is 

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

inspection pursuant to Section 11 of TSCA, must state the effective date of transfer, and must contain 
53 

provisions which expressly transfer liability for the PMN substance under the terms of this Order from 

the Company to the Successor in Interest. 

(e) Liability. 

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

effective date of the transfer described above. 

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

effective as of the date of transfer. 

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

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

during the time in which the Company manufactured, processed, used, distributed in commerce, or 

disposed of the PMN substance pursuant to the terms of this Consent Order. 

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

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

("test trigger"), the aggregate volume of the PMN substance manufactured and imported by the 

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

Interest. 

VI. MODIFICATION AND REVOCATION OF CONSENT ORDER 

The Company may petition EPA at any time, based upon new information on the human health 
54 

or environmental effects of, or human exposure to or environmental release of, the PMN substance, to 

modify or revoke substantive provisions of this Order. The exposures and risks identified by EPA 

during its review of the PMN substance and the information EPA determined to be necessary to 

evaluate those exposures and risks are described in the preamble to this Order. However, in 

determining whether to amend or revoke this Order, EPA will consider all relevant information available 

at the time the Agency makes that determination, including, where appropriate, any reassessment of the 

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

other information or analysis, and any other relevant information. 

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

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

significant or substantial human exposure or substantial environmental release in the absence of data 

sufficient to permit a reasoned evaluation of the health or environmental effects of the PMN substance. 

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

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

modification is useful, appropriate, and consistent with the structure and intent of this Order as issued. 
55 

VII. 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)(l)(C) ofTSCA, to receive service of this Order no later than 45 days 

before the end of the review period pursuant to section S(e)(l)(B) ofTSCA, and to challenge the 

validity of this Order in any subsequent action. Consenting to the entry of this Order, and agreeing to 

be bound by its terms, do not constitute an admission by the Company as to the facts or conclusions 

underlying the Agency's determinations in this proceeding. This waiver does not affect any other rights 

that the Company may have under TSCA. 

/6- ;:;z- oc? 

Date i 

Chemical Control Division 

Office of Pollution Prevention and Taxies 

Company: Arch Chemicals, Inc. 
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. 
2 

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

mixture containing that substance. 

"Immediate use." A chemical substance is for the "immediate use" of a person if it is under the 

control of, and used only by, the person who transferred it from a labeled container and will only be 

used by that person within the work shift in which it is transferred from the 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 
3 

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 longterm 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. 
ATTACHMENTB 

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 

• Form the ratio 

• Compute degrees of freedom 

where, 

X1 = Average of the results from the company laboratory 

X2 = Average of the results from the independent laboratory 

n1 =Number of samples analyzed by the company laboratory 

n2 =Number of samples analyzed by the independent laboratory. 
2 

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

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

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

In general, f may not be a integer. Use interpolation to obtain the 97.5 percentile point of at 

distribution with f degrees of freedom. 

EXAMPLES -- The following examples (based on simulated data) illustrate the method: 

Example 1 

X1 = 83.30 n1 = 6 

Data Set 1 

80.56 

100.01 

86.04 

52.61 

84.85 

95.75 

S1

1 

= 278.72 w 1 = 46.25 

Absolute value ofT = 2.467 

X2 = 100.40 

Sl = 9.26 

f = 5.33 

Data Set 2 

97.11 

102.13 

99.83 

97.83 

105.44 

100.04 

n2 = 6 

The t table shows that the 97.5 percentile point is 2.571 and 2.447 for 5 and 6 degrees of 

freedom, respectively. For 5.33 degrees of freedom, the 97.5 percentile point will be approximately 

2.530 which is greater than the absolute value ofT, 2.467. Hence, the means of two data sets are not 

significantly different at the 5% level. 

However, if this problem had been treated as an ordinary two-sample t test, the means would be 

significantly different at the 5% level because the absolute ofT is greater than 2.228, the 97.5 percentile 

point for the t distribution with 10 degrees of freedom. 

Example 2 

Data Set 1 

82.87 

101.85 

87.44 

Data Set 2 

108.05 

96.51 

100.04 
99.68 

101.15 

99.21 

Absolute value ofT = 2.2~.54 

3 

104.37 

S/ = 27.25 

104.33 

110.32 

107.00 

The t table shows that for 8 and 9 degrees of freedom the 97.5 percentile point is 2.306 and 

2.262, respectively. For 8.54 degrees of freedom the 97.5 percentile point will be approximately 2.282 

which is less than the absolute value ofT, 2.290. Hence, the means of two data sets are significantly 

different at the 5% level. 
Company (Transferor) 

ATTACHMENT C 

NOTICE OF TRANSFER 

OF 

TOXIC SUBSTANCES CONTROL ACT 

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1. Transfer of Manufacture Rights. Effective on , the Company did sell or otherwise 

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Transfer. 
2 

TOXIC SUBSTANCES CONTROL ACT 

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